Study Evaluating Venetoclax in Subjects With Hematological Malignancies

Sponsor
AbbVie
Study ID
NCT02265731
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)
  • Chronic Lymphocytic Leukemia (CLL)
  • Multiple Myeloma (MM)
  • Non-Hodgkin Lymphoma (NHL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

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

Interventions

Study Details

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

Key Dates

Start date
Sep 22, 2014
Status verified
Jul 2021
Primary completion
Mar 12, 2021
Completion
Mar 12, 2021

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Phase 1)
    Step-up doses of venetoclax to the designated cohort dose administered in participants with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL) or multiple myeloma (MM)
  • Experimental: Arm B (Phase 1)
    Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
  • Experimental: Arm C (Phase 1)
    Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML)
  • Experimental: Arm D (Phase 2)
    Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL

Primary Outcome Measure

Number of participants having treatment-emergent adverse events [ Time Frame: Approximately 2 years ]

Related Studies