Study of Ibrutinib in Subjects With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT02351037|
Recruitment Status : Terminated (Study data do not support development in AML.)
First Posted : January 30, 2015
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML)||Drug: Ibrutinib Drug: Ibrutinib + LD-AraC Drug: Ibrutinib+Azacitidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Open-Label Phase 2a Study of Ibrutinib Monotherapy or in Combination With Either Cytarabine or Azacitidine in Subjects With Acute Myeloid Leukemia|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Ibrutinib Monotherapy Cohort
Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.
Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
Other Name: Cohort 1
Experimental: Ibrutinib + LD-AraC Combination Cohort
Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Drug: Ibrutinib + LD-AraC
Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Other Name: Cohort 2
Experimental: Ibrutinib+Azacitidine Combination Cohort
Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).
Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
Other Name: Cohort 3
- Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines [ Time Frame: When the last subject enrolled completes approximately 12 months of treatment. ]Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/µL]) or thrombocytopenia (<100 x 109/L [100 000/µL]) ; Morphologic leukemia-free state, Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts > 5%; or reappearance of blasts in the blood; or development of extramedullary disease.
- Safety and Tolerability of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine [ Time Frame: Up to 30 days following the last dose of study drug. ]Number of Participants with Adverse Events and number of patients with lab abnormalities.The safety profile of ibrutinib was evaluated based on the incidence of adverse events (AEs) as well as clinically significant laboratory abnormalities and vital signs, and other malignancies. The safety evaluations performed in this study were standard and/or were required based on the safety data available from other clinical and preclinical settings.
- Relapse-free Survival (RFS), Event-free Survival (EFS) and Overall Survival (OS) [ Time Frame: When the last subject enrolled completes approximately 12 months of treatment ]To evaluate clinical efficacy by assessing relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).
- Clinical Benefit Rate - as Defined as the Proportion of Subjects Who Achieve CR, CRi, Morphologic Leukemia-free State, or Partial Remission (PR) [ Time Frame: When the last subject enrolled completes approximately 12 months of treatment ]To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).
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): NCT02351037
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|United States, Illinois|
|The University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|United States, New York|
|Montefiore Einstein Center for Cancer Research|
|Bronx, New York, United States, 10461|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Jorge Cortes, MD||M.D. Anderson Cancer Center|