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Rituximab With or Without Lenalidomide in Treating Patients With Previously Untreated Follicular Lymphoma

NCT01307605 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-06-27

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell 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. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known whether rituximab is more effective when given alone or together with lenalidomide in treating patients with follicular lymphoma.

PURPOSE: This randomized phase II trial is studying rituximab to see how well it works compared with giving rituximab together with lenalidomide in treating patients with previously untreated follicular lymphoma.

Conditions

Interventions

BIOLOGICAL

Rituximab

Rituximab (MabThera®) will be administered for a maximum of 8 infusions at weeks 1, 2, 3, 4 and again at weeks 12, 13, 14, 15 if the first restaging at week 10 (+/- 1 week) shows a partial response with at least more than 25% reduction in sum of product of diameters

DRUG

lenalidomide

Lenalidomide will be administered as 15 mg flat dose daily, starting 14 days before first and stopping 14 days after last rituximab administration.

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Emanuele Zucca, MD · Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

  • Eva K. Kimby, MD, PhD · Karolinska Institutet

  • Felicitas Hitz, MD · Cantonal Hospital of St. Gallen

  • Bjorn Ostenstad, MD · Ullevaal University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-09
Primary Completion
2014-06-20
Completion
2023-01-25

Countries

  • Norway
  • Sweden
  • Switzerland

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 NCT01307605 on ClinicalTrials.gov