Trial Outcomes & Findings for Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT00795002)
NCT ID: NCT00795002
Last Updated: 2018-08-07
Results Overview
Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.
COMPLETED
PHASE2
78 participants
1 year
2018-08-07
Participant Flow
All newly diagnosed adults diagnosed with AML were considered for participation.Enrolled on study between November 20, 2008 and July 20, 2010.
2 patients on each arm consented to study, but were screen failures and did not start treatment.
Participant milestones
| Measure |
Arm I
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
|
Arm II
Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
37
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm I
n=39 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
|
Arm II
n=39 Participants
Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
|
Total
n=78 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
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 54 • n=99 Participants
|
59 years
STANDARD_DEVIATION 53 • n=107 Participants
|
60 years
STANDARD_DEVIATION 58 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
39 participants
n=107 Participants
|
78 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy
Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.
Outcome measures
| Measure |
Arm I
n=37 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
|
Arm II
n=37 Participants
Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
|
|---|---|---|
|
Complete Response
|
24 participants
|
29 participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy. Toxicity defined as death from any cause within 60 days of starting FLAM.
Toxicity defined as death from any cause within 60 days of starting FLAM.
Outcome measures
| Measure |
Arm I
n=37 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
|
Arm II
n=37 Participants
Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
|
|---|---|---|
|
Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: 39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy.
This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.
Outcome measures
| Measure |
Arm I
n=37 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
|
Arm II
n=37 Participants
Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
|
|---|---|---|
|
Disease-free Survival
|
13.6 months
Interval 10.1 to
The 95% confidence interval is reported as 10.1 to infinity (10.1-inf)
|
12.0 months
Interval 9.2 to
The 95% confidence interval is reported as 9.2 to infinity (9.2-inf)
|
Adverse Events
Arm I
Arm II
Serious adverse events
| Measure |
Arm I
n=39 participants at risk
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
|
Arm II
n=39 participants at risk
Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
|
|---|---|---|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
10.3%
4/39 • Number of events 4 • 1 cycle of therapy
|
10.3%
4/39 • Number of events 4 • 1 cycle of therapy
|
|
Gastrointestinal disorders
Oral and/or Gastrointestinal mucositis
|
5.1%
2/39 • Number of events 2 • 1 cycle of therapy
|
5.1%
2/39 • Number of events 2 • 1 cycle of therapy
|
|
Cardiac disorders
Cardiac dysfunction
|
5.1%
2/39 • Number of events 2 • 1 cycle of therapy
|
5.1%
2/39 • Number of events 2 • 1 cycle of therapy
|
Other adverse events
| Measure |
Arm I
n=39 participants at risk
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
|
Arm II
n=39 participants at risk
Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
|
|---|---|---|
|
General disorders
General disorders-other
|
2.6%
1/39 • Number of events 1 • 1 cycle of therapy
|
2.6%
1/39 • Number of events 1 • 1 cycle of therapy
|
Additional Information
Judith Karp, MD
The Sidney Kimmel Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60