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Study Evaluating Venetoclax in Subjects With Hematological Malignancies

NCT02265731 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-08-02

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

azacitadine

75 mg/m2 by IV infusion or subcutaneous dosing

DRUG

venetoclax

Step-up doses of venetoclax to the designated cohort dose

DRUG

rituximab / IDEC-C2B8

375 mg/m2 on Week 6

DRUG

rituximab / IDEC-C2B8

500 mg/m2 Week 10 Day 1 and thereafter

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-22
Primary Completion
2021-03-12
Completion
2021-03-12

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02265731 on ClinicalTrials.gov