CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Bendamustine +2 moredrug
Likely dose
Bendamustine 90 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00974233
NCT00974233Phase 2Completed
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Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL

University of Wisconsin, Madison·interventional·Posted Sep 10, 2009·Updated Dec 2, 2019

In Brief

A Phase 2 clinical trial evaluating Bendamustine, Rituximab, and 1 other intervention for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Completed, enrolled 34 participants across 10 sites.

Detailed Summary

The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2009
Enrollment StartOct 1, 2009
Primary CompletionJul 1, 2013
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.8 years ago

Interventions

Bendamustinedrug

90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles

Rituximabdrug

375 mg/m2 Day 1 every 28 days for 6 cycles

Lenalidomidedrug

5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.