Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04435691|
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : November 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia||Drug: Azacitidine Biological: Magrolimab Drug: Venetoclax||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase IB/II Study of Magrolimab in Combination With Azacitidine and Venetoclax for the Treatment of Patients With Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||July 28, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: 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.
Given SC or IV
Other Name: Hu5F9-G4
- Maximum tolerated dose of the combination drugs (phase Ib) [ Time Frame: 28 days ]
- Response rate (complete remission + complete remission with incomplete count recovery) (phase II) [ Time Frame: Within 3 months of treatment initiation ]Will be monitored simultaneously. Will be estimated along with 95% credible intervals. Chi-square tests or Fisher's exact test will be used to evaluate the association between patient's prognostic factor and response.
- Incidence of adverse events (phase II) [ Time Frame: Within 3 months of treatment initiation ]Toxicities are defined as drug-related non-hematological grade >= 3 adverse events.
- Event-free survival (phase II) [ Time Frame: Time duration from the start of treatment to disease progression/death or censored at last follow-up while on the drug, assessed up to 100 days ]Kaplan-Meier method will be used.
- Duration of response (phase II) [ Time Frame: Up to 100 days ]Kaplan-Meier method will be used.
- Overall survival (phase II) [ Time Frame: Up to 100 days ]Kaplan-Meier method will be used.
- Change in gene expression (phase II) [ Time Frame: Baseline up to 100 days ]Paired t-tests will be used.
- Change in clinical variables (phase II) [ Time Frame: Baseline up to 100 days ]Paired t-tests will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435691
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Naval G. Daver 713-794-4392 firstname.lastname@example.org|
|Principal Investigator: Naval G. Daver|
|Principal Investigator:||Naval G Daver||M.D. Anderson Cancer Center|