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Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.

NCT00963534 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-03-12

No results posted yet for this study

Summary

In phase I: Establishing maximally tolerated dose of lenalidomide in combination with bendamustine and rituximab.

In phase II: Evaluation of progression free survival with treatment with lenalidomide, bendamustine and rituximab

Conditions

Interventions

DRUG

lenalidomide, bendamustine, rituximab

Phase I: Maximally tolerable dose of lenalidomide will be determined, starting with 5 mg per day, and up to maximally 25 mg per day. This treatment is given in combination with bendamustine and rituximab. Phase II: Determination of progression free survival with treatment with lenalidomide (dosing determined in phase I) in combination with bendamustine and rituximab.

DRUG

lenalidomide, bendamustine, rituximab

lenalidomide: day 1-21, maximum 13 cycles bendamustine: days 1-2, cycle 1-6 rituximab: day1, cycle 1-6

Sponsors & Collaborators

  • Mundipharma Pte Ltd.

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Lund University Hospital

    lead OTHER

Principal Investigators

  • Mats Jerkeman, MD, PhD · University Hospital Lund, Sweden

  • Jan Sundberg, RN · University Hospital Lund, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT00963534 on ClinicalTrials.gov