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A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)

NCT01671904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-10-14

No results posted yet for this study

Summary

This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V.

Conditions

Interventions

DRUG

Bendamustine

Participants will receive intravenous (IV) infusion of bendamustine (90 or 70 milligrams per square meter \[mg/m\^2\]) on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.

DRUG

Obinutuzumab

Participants will receive IV infusion of obinutuzumab (100 milligrams \[mg\]) on Day 1 of Cycle 1; 900 mg administered on Day 2 of Cycle 1; and 1000 mg administered on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.

DRUG

Rituximab

Participants will receive IV infusion of rituximab (375 mg/m\^2) on Day 1 of Cycle 1 and 500 mg/m\^2 administered on Day 1 of Cycles 2-6.

DRUG

Venetoclax

Participants will receive multiple doses of venetoclax orally once daily.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-13
Primary Completion
2018-08-17
Completion
2020-08-11

Countries

  • United States
  • France
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01671904 on ClinicalTrials.gov