Study of Ibrutinib in Subjects With Acute Myeloid Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02351037
Phase
PHASE2
Status
Terminated

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
  • Ibrutinib + LD-AraC — DRUG
    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.
  • Ibrutinib+Azacitidine — DRUG
    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).

Study Details

The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse standard chemotherapy.

Key Dates

Start date
Feb 28, 2015
Status verified
Jul 2018
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib Monotherapy Cohort
    Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.
  • 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.
  • 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).

Primary Outcome Measure

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. ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UC Davis Medical CenterSacramentoCalifornia95817-
The University of Chicago Medical CenterChicagoIllinois60637-
University of IowaIowa CityIowa52242-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-
Roswell Park Cancer InstituteBuffaloNew York14263-
Montefiore Einstein Center for Cancer ResearchThe BronxNew York10461-
MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUC Davis Medical Center· Sacramento, CAThe University of Chicago Medical Center· Chicago, ILUniversity of Iowa· Iowa City, IASidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDRoswell Park Cancer Institute· Buffalo, NY

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