CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Rituximab +3 morebiological
Likely dose
Rituximab 100 mgfrom 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/NCT00602836
NCT00602836Phase 2Completed

Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab Followed by Consolidation With Lenalidomide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Mayo Clinic·interventional·Posted Jan 28, 2008·Updated Jan 27, 2020

In Brief

A Phase 2 clinical trial evaluating Rituximab, Cyclophosphamide, and 2 other interventions for Leukemia and Lymphoma. Completed, enrolled 45 participants across 3 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with pentostatin, cyclophosphamide, and lenalidomide works in treating patients with previously untreated B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2010
Study CompletionSep 12, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

Rituximabbiological

Cycle 1: 100 mg by IV on day 1, 375 mg/m\^2 by IV on day 2 Cycle 2-6: 375 mg/m\^2 by IV on day 1 (every 21 days)

Cyclophosphamidedrug

600 mg/m\^2 by IV on day 1 of cycles 1-6 (every 21 days)

Lenalidomidedrug

Cycle 7: 5 mg orally daily on days 1-28 Cycle 8: 10 mg orally daily on days 1-28 as tolerability permits Cycle 9 and beyond: 10 mg orally daily on days 1-28

Pentostatindrug

2 mg/m\^2 by IV on day 1 of cycles 1-6 (every 21 days)