Trial Outcomes & Findings for Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia (NCT NCT04435691)
NCT ID: NCT04435691
Last Updated: 2026-04-23
Results Overview
The Maximum tolerated dose of Magrolimab, administered with Azacitidine 75 mg/m2 D1-7, and Venteoclax 400mg D1-28 will be selected at the end of the Phase 1b portion based on safety data.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Up to 12 cycles
Results posted on
2026-04-23
Participant Flow
no patient in phase 1b had any dose limiting toxicity (DLT), hence dose level '0" was selected as the recommended phase 2 dose (RP2D) and used for the phase 2 portion of the study
Participant milestones
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
104
|
|
Overall Study
COMPLETED
|
6
|
104
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
n=6 Participants
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
n=104 Participants
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=60 Participants
|
43 Participants
n=56 Participants
|
47 Participants
n=116 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=60 Participants
|
61 Participants
n=56 Participants
|
63 Participants
n=116 Participants
|
|
Age, Continuous
|
57 years
n=60 Participants
|
69 years
n=56 Participants
|
68 years
n=116 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=60 Participants
|
45 Participants
n=56 Participants
|
49 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=60 Participants
|
59 Participants
n=56 Participants
|
61 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=60 Participants
|
11 Participants
n=56 Participants
|
11 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=60 Participants
|
80 Participants
n=56 Participants
|
86 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
8 Participants
n=56 Participants
|
8 Participants
n=116 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=60 Participants
|
104 participants
n=56 Participants
|
110 participants
n=116 Participants
|
PRIMARY outcome
Timeframe: Up to 12 cyclesThe Maximum tolerated dose of Magrolimab, administered with Azacitidine 75 mg/m2 D1-7, and Venteoclax 400mg D1-28 will be selected at the end of the Phase 1b portion based on safety data.
Outcome measures
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
n=6 Participants
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
|---|---|---|
|
Maximum Tolerated Dose of the Combination Drugs (Phase Ib)
Magrolimab D1-4
|
1 mg/kg
|
—
|
|
Maximum Tolerated Dose of the Combination Drugs (Phase Ib)
Magrolimab D8
|
15 mg/kg
|
—
|
|
Maximum Tolerated Dose of the Combination Drugs (Phase Ib)
Magrolimab D11, 15 & 22
|
30 mg/kg
|
—
|
|
Maximum Tolerated Dose of the Combination Drugs (Phase Ib)
Magrolimab Cycle 2 weekly
|
30 mg/kg
|
—
|
|
Maximum Tolerated Dose of the Combination Drugs (Phase Ib)
Magrolimab Cycle 3+ every 2 weeks
|
30 mg/kg
|
—
|
PRIMARY outcome
Timeframe: Within 3 months of treatment initiationResponse is Complete Remission (CR) plus Complete remission with incomplete count recovery (CRi). Complete remission is peripheral blood counts, no circulating blasts, Neutrophil count \> 1.0 x 10\^9 L, Platelet count \> 100 x 10\^9/L and Bone marrow aspirate and biopsy \</=5% blasts no auer rods and no extramedullary leukemia. CRi is defined as peripheral blood counts, no circulating blasts, Neutrophil count \< 1.0 x 0\^9/L, OR platelet count\< 100 x 10\^9/L and Bone marrow aspirate and biopsy \</= 5% blasts, no auer rods and no extramedullary leukemia.
Outcome measures
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
n=6 Participants
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
n=104 Participants
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
|---|---|---|
|
Participants With a Response (Complete Remission + Complete Remission With Incomplete Count Recovery)
|
3 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: Up to 4 years, 7 months and 15 days.Time from date of treatment start until the date of failure or death from any cause.
Outcome measures
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
n=6 Participants
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
n=104 Participants
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
|---|---|---|
|
Event-free Survival
|
3.0 Months
Interval 2.0 to 19.2
|
4.2 Months
Interval 0.4 to 36.0
|
PRIMARY outcome
Timeframe: Up to 4 years, 7 months and 15 days.Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
n=6 Participants
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
n=104 Participants
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
|---|---|---|
|
Overall Survival
|
3.9 Months
Interval 3.8 to 21.5
|
6.5 Months
Interval 0.4 to 36.0
|
Adverse Events
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Ph II (Azacitidine, Venetoclax, Magrolimab)
Serious events: 87 serious events
Other events: 103 other events
Deaths: 84 deaths
Serious adverse events
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
n=6 participants at risk
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
n=104 participants at risk
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
3.8%
4/104 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Bacteremia
|
33.3%
2/6 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
12.5%
13/104 • Number of events 14 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Bladder spasm
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Bone infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Brain abscess
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Surgical and medical procedures
Desensitization of Bactrim
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 8 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
2.9%
3/104 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
2.9%
3/104 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
3/6 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
19.2%
20/104 • Number of events 27 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Fever
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
2.9%
3/104 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Gum infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Vascular disorders
Hematoma
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
2.9%
3/104 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Surgical and medical procedures
inguinal hernia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
3.8%
4/104 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Lung infection
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
34.6%
36/104 • Number of events 44 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Pain
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Reproductive system and breast disorders
Penile infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Eye disorders
Right subconjuctival hemorrhage
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
12.5%
13/104 • Number of events 15 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
3.8%
4/104 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Spinal cord compression
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Stroke
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
subcutaneous abscess (biopsy site)
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Injury, poisoning and procedural complications
Subcutaneous abscess biopsy site.
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
1.9%
2/104 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
|
Vascular disorders
thrombectomy
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
3.8%
4/104 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Viremia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Vulval infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
Other adverse events
| Measure |
Phase I MTD Treatment (Azacitidine, Venetoclax, Magrolimab)
n=6 participants at risk
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
Ph II (Azacitidine, Venetoclax, Magrolimab)
n=104 participants at risk
Participants in phase 2 were treated at the recommended phase 2 dose determined from the phase I portion of the study. Azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV 75 mg/m2 D1-7
Magrolimab: Given IV
1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11,15, 22 30 mg/kg weekly for Cycle 2 30 mg/kg Q2weeks for Cycle 3+
Venetoclax: Given PO 400mg D1-D28
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 13 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
10.6%
11/104 • Number of events 13 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
5.8%
6/104 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
12.5%
13/104 • Number of events 16 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
28.8%
30/104 • Number of events 49 • Up to 4 years, 7 months and 15 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
13.5%
14/104 • Number of events 16 • Up to 4 years, 7 months and 15 days.
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
14.4%
15/104 • Number of events 20 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
45.2%
47/104 • Number of events 76 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
43.3%
45/104 • Number of events 71 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
3/6 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
62.5%
65/104 • Number of events 117 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
26.0%
27/104 • Number of events 33 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
51.9%
54/104 • Number of events 100 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
55.8%
58/104 • Number of events 99 • Up to 4 years, 7 months and 15 days.
|
|
Vascular disorders
Hypotension
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
31.7%
33/104 • Number of events 45 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 8 • Up to 4 years, 7 months and 15 days.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
9.6%
10/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
26.0%
27/104 • Number of events 33 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Lethargy
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Lung infection
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
13.5%
14/104 • Number of events 14 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
25.0%
26/104 • Number of events 29 • Up to 4 years, 7 months and 15 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
16.3%
17/104 • Number of events 23 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
12.5%
13/104 • Number of events 15 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
43.3%
45/104 • Number of events 68 • Up to 4 years, 7 months and 15 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 9 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Neuralgia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
23.1%
24/104 • Number of events 31 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
13.5%
14/104 • Number of events 14 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Pain
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
12.5%
13/104 • Number of events 18 • Up to 4 years, 7 months and 15 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 14 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
10.6%
11/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Paresthesia
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
15.4%
16/104 • Number of events 17 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
15.4%
16/104 • Number of events 22 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
8.7%
9/104 • Number of events 10 • Up to 4 years, 7 months and 15 days.
|
|
Endocrine disorders
Polyuria and Polydipsia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
10.6%
11/104 • Number of events 14 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
21.2%
22/104 • Number of events 26 • Up to 4 years, 7 months and 15 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
5.8%
6/104 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
16.3%
17/104 • Number of events 19 • Up to 4 years, 7 months and 15 days.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Rectal mucositis
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
13.5%
14/104 • Number of events 15 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Rectal ulcer
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
14.4%
15/104 • Number of events 19 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Right foot cellulitis
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
9.6%
10/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Cardiac disorders
Sinus tachycardia
|
83.3%
5/6 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
29.8%
31/104 • Number of events 51 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
8.7%
9/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
9.6%
10/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
10.6%
11/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Spinal cord compression
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
stentrophomonas maltophilia bacteremia
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
5.8%
6/104 • Number of events 8 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Thrush
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
8.7%
9/104 • Number of events 10 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
6.7%
7/104 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
15.4%
16/104 • Number of events 19 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
9.6%
10/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
10.6%
11/104 • Number of events 11 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Urinary urgency
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
5.8%
6/104 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
urine frequency increased
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
30.8%
32/104 • Number of events 36 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
White blood cell decreased
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
16.3%
17/104 • Number of events 31 • Up to 4 years, 7 months and 15 days.
|
|
Injury, poisoning and procedural complications
Wound right lower extremity
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
0.00%
0/104 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
38.5%
40/104 • Number of events 61 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
4/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
30.8%
32/104 • Number of events 36 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
37.5%
39/104 • Number of events 52 • Up to 4 years, 7 months and 15 days.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 8 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
47.1%
49/104 • Number of events 67 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Dizziness
|
83.3%
5/6 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
26.9%
28/104 • Number of events 36 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
6.7%
7/104 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
34.6%
36/104 • Number of events 45 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
8.7%
9/104 • Number of events 9 • Up to 4 years, 7 months and 15 days.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
5.8%
6/104 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Edema face
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
6.7%
7/104 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Edema limbs
|
83.3%
5/6 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
40.4%
42/104 • Number of events 60 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
3/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
17.3%
18/104 • Number of events 28 • Up to 4 years, 7 months and 15 days.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
8.7%
9/104 • Number of events 9 • Up to 4 years, 7 months and 15 days.
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
16.3%
17/104 • Number of events 18 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Fatigue
|
100.0%
6/6 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
25.0%
26/104 • Number of events 30 • Up to 4 years, 7 months and 15 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
26.9%
28/104 • Number of events 35 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Fever
|
33.3%
2/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
42.3%
44/104 • Number of events 68 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Gait disturbance
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
14.4%
15/104 • Number of events 16 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
16.3%
17/104 • Number of events 18 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Generalized muscle weakness
|
66.7%
4/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
26.9%
28/104 • Number of events 30 • Up to 4 years, 7 months and 15 days.
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
40.4%
42/104 • Number of events 50 • Up to 4 years, 7 months and 15 days.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
5.8%
6/104 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
16.3%
17/104 • Number of events 21 • Up to 4 years, 7 months and 15 days.
|
|
Hepatobiliary disorders
Hepatomegaly
|
16.7%
1/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
0.96%
1/104 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
14.4%
15/104 • Number of events 20 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
18.3%
19/104 • Number of events 24 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Chills
|
50.0%
3/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
15.4%
16/104 • Number of events 18 • Up to 4 years, 7 months and 15 days.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 8 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
26.9%
28/104 • Number of events 38 • Up to 4 years, 7 months and 15 days.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 6 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
46.2%
48/104 • Number of events 79 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
36.5%
38/104 • Number of events 57 • Up to 4 years, 7 months and 15 days.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
11.5%
12/104 • Number of events 18 • Up to 4 years, 7 months and 15 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 8 • Up to 4 years, 7 months and 15 days.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 2 • Up to 4 years, 7 months and 15 days.
|
27.9%
29/104 • Number of events 33 • Up to 4 years, 7 months and 15 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
4/6 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
26.0%
27/104 • Number of events 34 • Up to 4 years, 7 months and 15 days.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
18.3%
19/104 • Number of events 19 • Up to 4 years, 7 months and 15 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • Number of events 3 • Up to 4 years, 7 months and 15 days.
|
27.9%
29/104 • Number of events 39 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
21.2%
22/104 • Number of events 28 • Up to 4 years, 7 months and 15 days.
|
|
General disorders
Back pain
|
66.7%
4/6 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
21.2%
22/104 • Number of events 27 • Up to 4 years, 7 months and 15 days.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
4.8%
5/104 • Number of events 5 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • Number of events 4 • Up to 4 years, 7 months and 15 days.
|
61.5%
64/104 • Number of events 106 • Up to 4 years, 7 months and 15 days.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
7.7%
8/104 • Number of events 19 • Up to 4 years, 7 months and 15 days.
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Number of events 1 • Up to 4 years, 7 months and 15 days.
|
6.7%
7/104 • Number of events 8 • Up to 4 years, 7 months and 15 days.
|
|
Injury, poisoning and procedural complications
Bruising
|
83.3%
5/6 • Number of events 7 • Up to 4 years, 7 months and 15 days.
|
14.4%
15/104 • Number of events 15 • Up to 4 years, 7 months and 15 days.
|
|
Blood and lymphatic system disorders
BUN INCREASED
|
0.00%
0/6 • Up to 4 years, 7 months and 15 days.
|
9.6%
10/104 • Number of events 14 • Up to 4 years, 7 months and 15 days.
|
Additional Information
Naval Daver MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place