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Trial Outcomes & Findings for Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT02096055)

NCT ID: NCT02096055

Last Updated: 2024-08-27

Results Overview

Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count \>/= 1.0 x 10\^9/L and platelet count \>/= 100 x 10\^9/L, and normal bone marrow differential (\</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of \< 100 x 109/L or ANC \< 1.0 x 109/L

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Up to 4 years, 3 months

Results posted on

2024-08-27

Participant Flow

Recruitment Period: April 2014 to July 2018

Participant milestones

Participant milestones
Measure
Arm I (Guadecitabine) x 5 Days
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Overall Study
STARTED
13
9
13
9
Overall Study
COMPLETED
13
9
13
9
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm I (Guadecitabine) x 5 Days
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=9 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
n=9 Participants
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Total
n=44 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Age, Categorical
>=65 years
13 Participants
n=99 Participants
9 Participants
n=107 Participants
13 Participants
n=206 Participants
9 Participants
n=7 Participants
44 Participants
n=31 Participants
Age, Continuous
73 years
n=99 Participants
76 years
n=107 Participants
75 years
n=206 Participants
76 years
n=7 Participants
75 years
n=31 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
4 Participants
n=107 Participants
4 Participants
n=206 Participants
2 Participants
n=7 Participants
12 Participants
n=31 Participants
Sex: Female, Male
Male
11 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
7 Participants
n=7 Participants
32 Participants
n=31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
White
11 Participants
n=99 Participants
8 Participants
n=107 Participants
13 Participants
n=206 Participants
9 Participants
n=7 Participants
41 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
2 Participants
n=31 Participants
Region of Enrollment
United States
13 participants
n=99 Participants
9 participants
n=107 Participants
13 participants
n=206 Participants
9 participants
n=7 Participants
44 participants
n=31 Participants

PRIMARY outcome

Timeframe: Up to 4 years, 3 months

Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count \>/= 1.0 x 10\^9/L and platelet count \>/= 100 x 10\^9/L, and normal bone marrow differential (\</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of \< 100 x 109/L or ANC \< 1.0 x 109/L

Outcome measures

Outcome measures
Measure
Arm I (Guadecitabine) x 5 Days
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=9 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
n=9 Participants
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Number of Participants With a Complete Response
5 Participants
5 Participants
10 Participants
0 Participants

PRIMARY outcome

Timeframe: Up to 4 years, 3 months

Population: Zero participants in the guadecitabine + Cladribine arm had a Complete Response.

The date of Complete Response to the date of loss of response or last follow-up.

Outcome measures

Outcome measures
Measure
Arm I (Guadecitabine) x 5 Days
n=5 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=5 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=10 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Remission Duration
7.4 Months
Interval 1.2 to 12.6
14.2 Months
Interval 5.7 to 19.0
5.3 Months
Interval 1.4 to 37.0
—

PRIMARY outcome

Timeframe: Up to 4 years, 3 months

Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. Time from date of treatment start until the date of first objective documentation of disease-relapse.

Outcome measures

Outcome measures
Measure
Arm I (Guadecitabine) x 5 Days
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=9 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
n=9 Participants
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Leukemia-free Survival
4.2 Months
Interval 2.1 to 13.9
10.0 Months
Interval 0.5 to 21.7
7.4 Months
Interval 2.0 to 39.5
4.3 Months
Interval 1.1 to 28.9

PRIMARY outcome

Timeframe: Up to 4 years, 3 months

Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.

Outcome measures

Outcome measures
Measure
Arm I (Guadecitabine) x 5 Days
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=9 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
n=9 Participants
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Survival
13.1 Months
Interval 3.3 to 28.8
13.0 Months
Interval 0.5 to 43.8
15.4 Months
Interval 2.0 to 47.0
11.9 Months
Interval 1.9 to 28.9

PRIMARY outcome

Timeframe: Up to 4 years, 3 months

The most frequently reported adverse events will be determined by the Principal Investigator. The number of participants who experienced the most frequent grade 3 or 4 adverse events will be reported.

Outcome measures

Outcome measures
Measure
Arm I (Guadecitabine) x 5 Days
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=9 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=13 Participants
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
n=9 Participants
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.
Infection/Sepsis
4 Participants
8 Participants
8 Participants
9 Participants
Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.
Febrile Neutropenia
5 Participants
2 Participants
4 Participants
9 Participants
Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.
Fatigue
0 Participants
0 Participants
3 Participants
0 Participants

Adverse Events

Arm I (Guadecitabine) x 5 Days

Serious events: 9 serious events
Other events: 13 other events
Deaths: 2 deaths

Arm II (CLOSED) (Guadecitabine) x 10 Days

Serious events: 7 serious events
Other events: 7 other events
Deaths: 1 deaths

Arm III (Guadecitabine, Idarubicin)

Serious events: 10 serious events
Other events: 13 other events
Deaths: 1 deaths

Arm IV (CLOSED) (Guadecitabine, Cladribine)

Serious events: 6 serious events
Other events: 9 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
Arm I (Guadecitabine) x 5 Days
n=13 participants at risk
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=9 participants at risk
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=13 participants at risk
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
n=9 participants at risk
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Cardiac disorders
Acute Coronary Syndrome
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Blood and lymphatic system disorders
Anemia
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Atrial Fibrillation
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Back Pain
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 2 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Breast Infection
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 2 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary Hemorrhage
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Catheter related infection
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Chest Pain
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Death
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Dehydration
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Diarrhea
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Nervous system disorders
Dizziness
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 4 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Injury, poisoning and procedural complications
Fall
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Fatigue
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Blood and lymphatic system disorders
Neutropenic Fever
30.8%
4/13 • Number of events 7 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 3 • Up to 4 years, 3 months
30.8%
4/13 • Number of events 5 • Up to 4 years, 3 months
66.7%
6/9 • Number of events 9 • Up to 4 years, 3 months
General disorders
Fever
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Hepatobiliary disorders
Gallbladder infection
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Musculoskeletal and connective tissue disorders
Muscle Weakness
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Heart Failure
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 3 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Vascular disorders
Hypotension
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Ileus
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Infection
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Lung infection
30.8%
4/13 • Number of events 4 • Up to 4 years, 3 months
33.3%
3/9 • Number of events 3 • Up to 4 years, 3 months
23.1%
3/13 • Number of events 3 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Myocardial Infarction
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Musculoskeletal and connective tissue disorders
Myositis
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Nausea
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Non-Cardiac Chest Pain
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Pain Extremity
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Respiratory failure
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Nervous system disorders
Seizure
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Sepsis
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Sinus bradycardia
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Sinusitis
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Skin Infection
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Infections and infestations
Soft tissue infection
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Supraventricular tachycardia
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Vascular disorders
Thromboembolic Event
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 2 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Renal and urinary disorders
Urinary Retention
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Urinary tract infeciton
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months

Other adverse events

Other adverse events
Measure
Arm I (Guadecitabine) x 5 Days
n=13 participants at risk
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm II (CLOSED) (Guadecitabine) x 10 Days
n=9 participants at risk
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC
Arm III (Guadecitabine, Idarubicin)
n=13 participants at risk
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV
Arm IV (CLOSED) (Guadecitabine, Cladribine)
n=9 participants at risk
INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC
Immune system disorders
Allergy
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Blood and lymphatic system disorders
Anemia
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Gastrointestinal disorders
Anorexia
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Cardiac disorders
Atrial Fibrillation
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Renal and urinary disorders
Bladder Spasms
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Bloating
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Injury, poisoning and procedural complications
Bruising
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Cardiac Ischemia/Infarction
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
General disorders
Chest Pain
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Cholecystitis
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Colitis
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Psychiatric disorders
Confusion
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Cardiac disorders
Congestive Heart Failure
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Constipation
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
46.2%
6/13 • Number of events 6 • Up to 4 years, 3 months
44.4%
4/9 • Number of events 4 • Up to 4 years, 3 months
General disorders
Constitutional Symptoms
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
33.3%
3/9 • Number of events 4 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Metabolism and nutrition disorders
Dehydration
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Skin and subcutaneous tissue disorders
Dermatology Skin/Other
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 2 • Up to 4 years, 3 months
Gastrointestinal disorders
Diarrhea
30.8%
4/13 • Number of events 4 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
46.2%
6/13 • Number of events 6 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Nervous system disorders
Dizziness
0.00%
0/13 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
23.1%
3/13 • Number of events 3 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/13 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Renal and urinary disorders
Dysuria
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Edema Limb
23.1%
3/13 • Number of events 3 • Up to 4 years, 3 months
44.4%
4/9 • Number of events 4 • Up to 4 years, 3 months
53.8%
7/13 • Number of events 7 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Investigations
Elevated Alanine Aminotransferase
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Investigations
Elevated Aspartate Aminotransferase
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Fatigue
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
30.8%
4/13 • Number of events 4 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
General disorders
Fever
7.7%
1/13 • Number of events 2 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Flatulence
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Flu-like syndrome
0.00%
0/13 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Vascular disorders
Flushing
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Heartburn
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Hemorrhage
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
15.4%
2/13 • Number of events 3 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Investigations
Hyperbillirubinemia
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
Metabolism and nutrition disorders
Hypomagnesemia
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Vascular disorders
Hypotension
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Infections and infestations
Infection
23.1%
3/13 • Number of events 5 • Up to 4 years, 3 months
77.8%
7/9 • Number of events 14 • Up to 4 years, 3 months
61.5%
8/13 • Number of events 15 • Up to 4 years, 3 months
66.7%
6/9 • Number of events 11 • Up to 4 years, 3 months
Psychiatric disorders
Insomnia
30.8%
4/13 • Number of events 4 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
30.8%
4/13 • Number of events 4 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Nervous system disorders
Memory Impairment
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Mucositis
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
55.6%
5/9 • Number of events 5 • Up to 4 years, 3 months
Musculoskeletal and connective tissue disorders
Muscle weakness
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other (Specify)
0.00%
0/13 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Nausea
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
23.1%
3/13 • Number of events 3 • Up to 4 years, 3 months
55.6%
5/9 • Number of events 5 • Up to 4 years, 3 months
Nervous system disorders
Neurology-Other (Specify)
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Nervous system disorders
Neuropathy
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 2 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Investigations
Neutropenia
15.4%
2/13 • Number of events 3 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Blood and lymphatic system disorders
Neutropenic Fever
30.8%
4/13 • Number of events 6 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 2 • Up to 4 years, 3 months
30.8%
4/13 • Number of events 4 • Up to 4 years, 3 months
77.8%
7/9 • Number of events 10 • Up to 4 years, 3 months
Gastrointestinal disorders
Obstruction GI
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Pain
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
30.8%
4/13 • Number of events 6 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Vascular disorders
Phlebitis
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Pleural effusion
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Skin and subcutaneous tissue disorders
Pruritus/itching
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Skin and subcutaneous tissue disorders
Rash/desquamation
38.5%
5/13 • Number of events 5 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
15.4%
2/13 • Number of events 2 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 2 • Up to 4 years, 3 months
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation--Select
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Nervous system disorders
Seizure
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Sinus Bradycardia
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
General disorders
Sweating
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Nervous system disorders
Syncope
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Investigations
thrombocytopenia
15.4%
2/13 • Number of events 3 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Vascular disorders
Thrombosis/embolism (vascular access-related)
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
22.2%
2/9 • Number of events 3 • Up to 4 years, 3 months
30.8%
4/13 • Number of events 4 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Nervous system disorders
Tremor
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Skin and subcutaneous tissue disorders
Ulceration
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Renal and urinary disorders
Urinary frequency/urgency
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Cardiac disorders
Ventricular arrhythmia--Select
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
Gastrointestinal disorders
Vomiting
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/13 • Up to 4 years, 3 months
11.1%
1/9 • Number of events 1 • Up to 4 years, 3 months
Investigations
Weight Loss
0.00%
0/13 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months
7.7%
1/13 • Number of events 1 • Up to 4 years, 3 months
0.00%
0/9 • Up to 4 years, 3 months

Additional Information

Hagop Kantarjian, MD/Chair

The University of Texas MD Anderson Cancer Center

Phone: 713-792-7026

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place