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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mundipharma Pte Ltd.
Celgene Corporation
Roche Pharma AG
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00963534
First received: August 20, 2009
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Mantle Cell Lymphoma
Drug: lenalidomide, bendamustine, rituximab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • MTD of lenalidomide (phase I) Progression free survival (phase II) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lenalidomide, bendamustine, rituximab 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

Detailed Description:

This trial consists of both a phase I portion and a phase II portion. In phase I, the MTD of lenalidomide is determined, starting with 5 mg/day given up to maximally 25 mg/day. In combination with this treatment, bendamustine and rituximab are given at fixed doses.

The phase I portion follows a sequential dose escalation, 3+3 design. Initially, three subjects are started treatment with dose regimen 1 (5 mg/day). After the third subject completed two cycles of treatment, if no DLT has occured, the next group of three subjects are treated at the next dose level of lenalidomide (10 mg/day). If one of the three initial subjects experiences a DLT, the cohort is expanded to six subjects. If less than two out of the six subjects experiences a DLT, then the next higher dose group is initiated. If two or more subjects experiences a DLT, no higher dose levels will be tested and the MTD dose has been exceeded.

Additional subjects are enrolled at the MTD on the phase II portion of the trial.

The above described treatment with lenalidomide, bendamustine and rituximab are given in 6 cycles, cycle length 22 days. Lenalidomide is given day 1-21, bendamustine day 1-2 and rituximab day 1. During the following maintenance treatment, single treatment with lenalidomide will be given with the same dose of lenalidomide (25 mg/day) for 7 cycles, whether in phase I or phase II portion of the trial.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 65 years, or age under 65 years, unable to tolerate high dose chemotherapy with autologous stem cell support
  • Histologically confirmed mantle cell lymphoma, stage II-IV at time of diagnosis
  • No previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma
  • WHO Performance Status 0-3
  • Written informed concent
  • Female subjects of childbearing potential must agree to use and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, through study drug therapy and for 4 weeks after the end of study drug therapy
  • Male subjects must agree to use condoms throughout study drug therapy if their partner is of childbearing potential, and has no contraception, and agree to not donate semen during study drug therapy and for one week after end of study drug therapy
  • All subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation, and agree not to share study medication with another person

Exclusion Criteria:

  • Impaired liver function
  • ANC less than 1.0 x 10 9, unless caused by bone marrow infiltration by lymphoma
  • Platelet count less than 60 x 10 9, unless caused by bone marrow infiltration by lymphoma
  • Creatinine clearance below 50 ml/min (cockcroft formula))
  • Known HIV positivity
  • Known seropositivity for HCV, HBsAG, anti-HBc, or other active infection uncontrolled by treatment
  • Psychiatric illness or condition which could interfere with the subject´s ability to understand the requirements of the study
  • Requirement of corticosteroid therapy at a dose over 10 mg prednisolone/day
  • Pregnant or lactating females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963534

Locations
Denmark
Rigshospitalet, Department of Hematology
Copenhagen, Denmark
Herlev Hospital
Copenhagen, Denmark
Århus University Hospital
Århus, Denmark
Finland
Helsinki University Central Hospital
Helsinki, Finland
Norway
Haukeland University Hospital, Department of Oncology
Bergen, Norway
Norwegian Radium Hospital
Oslo, Norway
Ulleval University Hospital, Department of Oncology
Oslo, Norway
University Hospital of Stavanger, Department of Haematology and Oncology
Stavanger, Norway
University Hospital of Tromso, Department of Oncology
Tromso, Norway
Sweden
Sahlgrenska University Hospital, Department of Hematology
Göteborg, Sweden, 413 45
University Hospital Linköping, Department of Hematology
Linköping, Sweden, 581 85
Sunderbyn Hospital, Department of Medicine
Luleå, Sweden, 971 80
University Hospital Lund, Department of Oncology
Lund, Sweden, 221 85
Karolinska University Hospital, Department of Hematology
Stockholm, Sweden, 171 76
Sundsvall Hospital, Department of Medicine
Sundsvall, Sweden, 851 86
University Hospital of Norrland, Department of Oncology
Umeå, Sweden, 981 85
Uppsala University Hospital, Department of Oncology
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Lund University Hospital
Mundipharma Pte Ltd.
Celgene Corporation
Roche Pharma AG
Investigators
Principal Investigator: Mats Jerkeman, MD, PhD University Hospital Lund, Sweden
Study Director: Jan Sundberg, RN University Hospital Lund, Sweden
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT00963534     History of Changes
Other Study ID Numbers: NLG-MCL4
Study First Received: August 20, 2009
Last Updated: September 25, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University Hospital:
Mantle cell lymphoma
Lenalidomide
Bendamustine
Rituximab
Nordic Lymphoma Group
MTD for lenalidomide
Untreated patients
Patients with mantle cell lymphoma, age over 65 years

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine
Rituximab
Lenalidomide
Nitrogen Mustard Compounds
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014