Lirilumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT02399917|
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Biphenotypic Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia||Drug: Azacitidine Other: Laboratory Biomarker Analysis Biological: Lirilumab||Phase 2|
I. To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of lirilumab in combination with 5-azacytidine (azacitidine) in patients with refractory/relapsed acute myeloid leukemia (AML). (Part A, Lead-In Phase) II. To determine the overall response rate (ORR) of lirilumab in combination with 5-azacytidine in patients with refractory/relapsed AML. (Part B, Phase II)
I. To determine the duration of response, disease-free survival (DFS), and overall survival (OS) of patients with refractory/relapsed AML treated with this combination.
II. To determine the safety of lirilumab in combination with 5-azacytidine in patients with refractory/relapsed AML.
I. To study immunological and molecular changes in the peripheral blood and bone marrow in response to lirilumab and 5-azacytidine therapy.
II. To determine induction of hypomethylation and deoxyribonucleic acid (DNA) damage during therapy with this combination and its correlation with response.
Patients receive azacitidine subcutaneously (SC) or intravenously (IV) over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and up to 90 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase II Study of Lirilumab (BMS-986015) in Combination With 5-Azacytidine (Vidaza) for the Treatment of Patients With Refractory/Relapsed Acute Myeloid Leukemia|
|Actual Study Start Date :||April 20, 2015|
|Actual Primary Completion Date :||July 12, 2018|
|Actual Study Completion Date :||July 12, 2018|
Experimental: Treatment (azacitidine, lirilumab)
Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given SC or IV
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose of azacitidine, defined as the dose at which =< 1/6 patients experience dose limiting toxicity (Part A, Lead-In Phase) [ Time Frame: Up to 28 days ]
- Objective response rate (ORR), defined as complete remission (CR) + CR with incomplete platelet recovery + CR with incomplete count recovery + partial response + marrow clearance of blasts + hematological improvement (Part B, Phase II) [ Time Frame: Up to 3 months ]ORR will be monitored using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung. The target ORR with the experimental treatment is 30%. This regimen of the combination treatment will be considered worthy of further investigation if it elicits an increase in ORR to 30% with acceptable toxicity.
- Toxicity rate [ Time Frame: Up to 30 days after completion of study treatment ]Toxicity will be monitored simultaneously using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung. A > 30% therapy related grade 3/4 toxicity rate is considered unacceptable.
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): NCT02399917
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naval Daver||M.D. Anderson Cancer Center|