Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma. (LENA-BERIT)
This study is currently recruiting participants.
Verified November 2012 by Lund University Hospital
Sponsor:
Lund University Hospital
Collaborators:
Mundipharma
Celgene Corporation
Roche Pharma AG
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00963534
First received: August 20, 2009
Last updated: November 14, 2012
Last verified: November 2012
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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. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963534
Contacts
| Contact: Mats Jerkeman, MD PhD | +46 46 17 10 00 | mats.jerkeman@med.lu.se |
| Contact: Jan Sundberg, RN | +46 46 17 70 34 | jan.sundberg@skane.se |
Locations
| Denmark | |
| Rigshospitalet, Department of Hematology | Recruiting |
| Copenhagen, Denmark | |
| Contact: Christian Geisler, MD christian.geisler@regionh.dk | |
| Principal Investigator: Christian Geisler, MD | |
| Herlev Hospital | Not yet recruiting |
| Copenhagen, Denmark | |
| Contact: Michael Pedersen, MD micped06/her@exchange.ka | |
| Principal Investigator: Michael Pedersen, MD | |
| Århus University Hospital | Not yet recruiting |
| Århus, Denmark | |
| Contact: Herluf Bentzen, MD hanbe@as.aaa.dk | |
| Principal Investigator: Hans Herluf Bentzen, MD | |
| Finland | |
| Helsinki University Central Hospital | Recruiting |
| Helsinki, Finland | |
| Contact: Riikka Räty, MD riikka.raty@hus.fi | |
| Principal Investigator: Riikka Räty, MD | |
| Norway | |
| Haukeland University Hospital, Department of Oncology | Not yet recruiting |
| Bergen, Norway | |
| Contact: Oystein Fluge, MD oystein.fluge@helse-bergen.no | |
| Principal Investigator: Oystein Fluge, MF | |
| Norwegian Radium Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Arne Kolstad, MD arne.kolstad@radiumhospitalet.no | |
| Principal Investigator: Arne Kolstad, MD | |
| Ulleval University Hospital, Department of Oncology | Not yet recruiting |
| Oslo, Norway | |
| Contact: Bjorn Ostenstad, MD bjorn.ostenstad@ulleval.no | |
| Principal Investigator: Bjorn Ostenstad, MD | |
| University Hospital of Stavanger, Department of Haematology and Oncology | Recruiting |
| Stavanger, Norway | |
| Contact: Peter Meyer, MD mepe@sir.no | |
| Principal Investigator: Peter Meyer, MD | |
| University Hospital of Tromso, Department of Oncology | Not yet recruiting |
| Tromso, Norway | |
| Contact: Martin Maisenholder, MD martin.maisenholder@unn.no | |
| Principal Investigator: Martin Maisenholder, MD | |
| Sweden | |
| Sahlgrenska University Hospital, Department of Hematology | Recruiting |
| Göteborg, Sweden, 413 45 | |
| Contact: Herman Nilsson-Ehle, MD herman.n-ehle@vgregion.se | |
| Principal Investigator: Herman Nilsson-Ehle, MD | |
| University Hospital Linköping, Department of Hematology | Recruiting |
| Linköping, Sweden, 581 85 | |
| Contact: Ingemar Lagerlöf, MD ingemar.lagerlof@lio.se | |
| Principal Investigator: Ingemar Lagerlöf, MD | |
| Sunderbyn Hospital, Department of Medicine | Recruiting |
| Luleå, Sweden, 971 80 | |
| Contact: Lena Brändefors, MD lena.brandefors@nll.se | |
| Principal Investigator: Lena Brandefors, MD | |
| University Hospital Lund, Department of Oncology | Recruiting |
| Lund, Sweden, 221 85 | |
| Contact: Mats Jerkeman, MD, PhD +46 46 17 10 00 mats.jerkeman@med.lu.se | |
| Contact: Jan Sundberg, RN +46 46 17 70 34 jan.sundberg@skane.se | |
| Principal Investigator: Mats Jerkeman, MD, PhD | |
| Karolinska University Hospital, Department of Hematology | Recruiting |
| Stockholm, Sweden, 171 76 | |
| Contact: Eva Kimby, MD eva@kimby.se | |
| Principal Investigator: Eva Kimby, MD | |
| Sundsvall Hospital, Department of Medicine | Recruiting |
| Sundsvall, Sweden, 851 86 | |
| Contact: Maria Strandberg, MD maria.strandberg@lvn.se | |
| Principal Investigator: Maria Strandberg, MD | |
| University Hospital of Norrland, Department of Oncology | Recruiting |
| Umeå, Sweden, 981 85 | |
| Contact: Martin Erlanson, MD martin.erlanson@onkologi.umu.se | |
| Principal Investigator: Martin Erlanson, MD, PhD | |
| Uppsala University Hospital, Department of Oncology | Recruiting |
| Uppsala, Sweden, 751 85 | |
| Contact: Anna Laurell, MD anna.laurell@akademiska.se | |
| Principal Investigator: Anna Laurell, MD, PhD | |
Sponsors and Collaborators
Lund University Hospital
Mundipharma
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: | November 14, 2012 |
| 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 May 23, 2013