A Phase II, Multicenter, Randomized, Controlled, Open-label Study of the Safety, Efficacy and Pharmacokinetics of ABT-263 in Combination With Dose-intensive Rituximab, or Dose-intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)

Genentech, Inc.0 sites118 target enrollmentAugust 2010

ConditionsChronic Lymphocytic Leukemia

InterventionsABT-263 rituximab

DrugsABT-263 rituximab

Overview

Phase: Phase 2
Intervention: ABT-263
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Genentech, Inc.
Enrollment: 118
Primary Endpoint: Progression-free survival
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

June 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Previously untreated, CD20-positive B-cell CLL
•ECOG performance status of 0 or 1
•Life expectancy \> 6 months
•Willingness and capability to be accessible for follow-up until study termination or death
•For patients of reproductive potential (both males and females), use of a reliable means of contraception

Exclusion Criteria

•Prolymphocytic leukemia
•Richter's transformation to an aggressive B-cell malignancy (e.g., DLBCL)
•Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of progression at baseline
•Patients with a history of other malignancies within 2 years prior to study entry except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade, localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy alone with curative intent
•Prior treatment with rituximab, ABT-263 or other pro-apoptotic agents
•Current or recent (within the 28 days prior to initiation of study treatment) participation in another experimental drug study
•Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to treatment onset or anticipation of the need for major surgery during the course of the study
•Active infection requiring parenteral antibiotics or antiviral or antifungal agents at the onset of study treatment
•Receipt of primary or booster vaccination with live-virus vaccines for up to 6 months prior to initiation of study treatment
•Patients receiving therapeutic anticoagulation with heparin or warfarin or patients receiving any drugs or herbal supplements that are known to inhibit platelet function (including low-dose aspirin) within 7 days of the first dose of ABT-

Arms & Interventions

C

Intervention: ABT-263

A

Intervention: rituximab

B

Intervention: ABT-263

B

Intervention: rituximab

C

Intervention: rituximab

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])

Secondary Outcomes

ORR as assessed by a blinded, independent review(Approximately 40 months from FPI)
Duration of response as assessed by a blinded, independent review(Approximately 40 months from FPI)
Overall survival (OS)(From randomization until death due to any cause (approximately 4 years after Last Patient In))
Duration of response(Approximately 40 months from FPI)
Overall response rate (ORR)(Approximately 40 months from FPI)
Complete response (CR) rate(Approximately 40 months from FPI)
Progression-free survival as assessed by a blinded, independent review(From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI))
CR rate as assessed by a blinded, independent review(Approximately 40 months from FPI)