Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)
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|ClinicalTrials.gov Identifier: NCT03699384|
Recruitment Status : Withdrawn (Study sponsor discontinued support)
First Posted : October 9, 2018
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Minimal Residual Disease||Drug: Azacitidine Drug: Avelumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open label, phase I/II prospective clinical trial.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)|
|Actual Study Start Date :||October 3, 2018|
|Actual Primary Completion Date :||February 18, 2019|
|Actual Study Completion Date :||February 18, 2019|
Experimental: Azacitidine and Avelumab
All enrolled patients will receive 1 cycle of AZA followed by cycles of combination AZA+Avelumab.
AZA 75 mg/m^2 SC or IV D 1-7 28 day cycle x 1
Avelumab 10mg/kg IV D1, D15, 28d cycle Until progression or MRD If MRD-, tx x 1 yr or go to allo SCT
- Number of patients with dose limiting toxicities as assessed by CTCAE v4.0 [ Time Frame: 1 year ]Up to 6 pre-allo SCT patients who are evaluable for DLT will be enrolled, with the first 3 patients enrolled in a sequential manner with a 1-week interval between the start of dosing for each patient. If the regimen appears tolerable in the first 3 patients (i.e., ≤ 1 of the first 3 patients enrolled experiences a DLT), then the next 3 patients will be enrolled concurrently. If more than 1 out of 6 in the pre-alloSCT group has a DLT, the trial will stop accrual. The combination will be considered safe in pre-allo SCT patients if one or no patient has a DLT out of the six patients. If the combination is safe in pre-alloSCT patients, additional pre-alloSCT patients will begin enrollment for the expanded phase II portion of the study, and accrual of 6 post-alloSCT patients for separate safety evaluation will begin. Toxicity will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- sustained MRD negativity (Phase II) [ Time Frame: 1 year ]This is defined as the time from the first dose of azacitidine to a patient"s confirmed MRD negativity on the second bone marrow.
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): NCT03699384
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Aaron Goldberg, MD, PhD||Memorial Sloan Kettering Cancer Center|