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Completed

NCT Number: NCT02265731

Study Evaluating Venetoclax in Subjects With Hematological Malignancies

This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have histologically documented diagnosis of NHL (and exhausted options considered standard of care) as defined in the World Health Organization classification scheme and relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. Participants with other lymphoproliferative diseases can be considered in consultation with the AbbVie medical monitor
  • Relapsed or refractory multiple myeloma participants must have been previously treated with at least one prior line of therapy and have measurable disease
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma participants must have relapsed or be refractory to standard treatments such as fludarabine based regimens or alkylator based regimens
  • Untreated AML subjects or Relapsed or refractory AML subjects must have been previously treated with at least one prior line of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1; adequate bone marrow independent of growth factor support per local laboratory reference range; and adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening
  • Participants with a history of autologous or allogenic stem cell transplantation must have adequate blood counts independent of growth factor support and have recovered from any transplant-related toxicity(s) and be at least 100 days post-autologous transplant (multiple myeloma) or 6 month post-autologous transplant (NHL) prior to first dose of study drug or at least 6 months post-allogenic transplant (multiple myeloma) prior to first dose of study drug and not have active graft-versus-host disease (GVHD), i.e., requiring treatment

Exclusion criteria

  • NHL participants who have undergone an allogeneic stem cell transplant or were diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia
  • Participant tested positive for HIV
  • Participant has a cardiovascular disability status of New York Heart Association Class greater or equal to 2
  • Participant has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
  • Participant received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.

Treatment and study plan

Azacitadine

Drug

75 mg/m2 by IV infusion or subcutaneous dosing

Venetoclax

Drug

Step-up doses of venetoclax to the designated cohort dose

rituximab / IDEC-C2B8

Drug

375 mg/m2 on Week 6

Primary outcomes

  1. Number of participants having treatment-emergent adverse events

    Time frame: Approximately 2 years

    Collect all adverse events at each visit

  2. Time to maximum plasma concentration (Tmax) of venetoclax

    Time frame: Approximately 8 days

  3. Maximum plasma concentration (Cmax) of venetoclax

    Time frame: Approximately 8 days

  4. Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax

    Time frame: Approximately 8 days

  5. Objective Response Rate (Phase 2)

    Time frame: Approximately 48 months

    The proportion of participants with response (e.g., partial, complete response) using IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).

Secondary outcomes

  1. Objective Response Rate (Phase 1)

    Time frame: Approximately 48 months

    The proportion of participants with response (e.g., partial, complete response) using IWG (International Working Group) response criteria for NHL participants, IMWG (International Myeloma Working Group) response criteria for multiple myeloma participants, IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants or IWG (International Working Group) criteria for AML participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).

  2. Minimal Residual Disease (MRD)

    Time frame: Approximately 2 years

  3. Duration of Response

    Time frame: Approximately 48 months

    Duration of response is defined as the number of days from the participant's initial response (e.g., partial, complete response per disease-appropriate response criteria) to the day that disease progression is objectively documented.

  4. Time to disease progression

    Time frame: Approximately 48 months

    Time to disease progression is defined as the number of days from the date the subject started the study drug to the date of the subject's progression (all events of progression will be included).

  5. complete response or remission (CR) rate

    Time frame: Approximately 48 months

    CR rate will be defined as the proportion of participants who achieved a complete response or remission (CR) or complete response with incomplete bone marrow recovery or complete remission with incomplete count recovery (CRi) per the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.

  6. Partial response or remission (PR) rate

    Time frame: Approximately 48 months

    PR rate will be defined as the proportion of subjects who achieved a nodular PR (nPR) or PR per the 2008 IWCLL criteria.

  7. Progression Free Survival (PFS)

    Time frame: Approximately 48 months

    Duration of progression-free survival (PFS) will be defined as the number of days from the date of first dose to the date of earliest disease progression or death.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Oct 16, 2014
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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