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Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma

NCT01829568 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-13

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving lenalidomide and ibrutinib together with rituximab may work well in treating follicular lymphoma.

Conditions

  • Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage III Grade 3 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 3 Follicular Lymphoma

Interventions

DRUG

Ibrutinib

Given PO

DRUG

Lenalidomide

Given PO

BIOLOGICAL

Rituximab

Given IV

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Chaitra S Ujjani · Alliance for Clinical Trials in Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-26
Primary Completion
2015-05-11
Completion
2026-06-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01829568 on ClinicalTrials.gov