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Combination of Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL)

NCT01446133 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-22

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control CLL. The safety of this drug combination will also be studied.

Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.

Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.

Conditions

Interventions

DRUG

Rituximab

375 mg/m2 by vein on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2.

DRUG

Lenalidomide

10 mg/day by mouth daily beginning on Day 9 of cycle 1.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Alessandra Ferrajoli, MD,BS · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-12
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01446133 on ClinicalTrials.gov