Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
LENA-BERIT
1 other identifier
interventional
51
4 countries
17
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2009
Longer than P75 for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMarch 12, 2018
March 1, 2018
7.9 years
August 20, 2009
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MTD of lenalidomide (phase I) Progression free survival (phase II)
2 years
Study Arms (1)
lenalidomide, bendamustine, rituximab
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund University Hospitallead
- Mundipharma Pte Ltd.collaborator
- Celgenecollaborator
- Roche Pharma AGcollaborator
Study Sites (17)
Århus University Hospital
Aarhus, Denmark
Herlev Hospital
Copenhagen, Denmark
Rigshospitalet, Department of Hematology
Copenhagen, Denmark
Helsinki University Central Hospital
Helsinki, Finland
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
Tromsø, Norway
Sahlgrenska University Hospital, Department of Hematology
Gothenburg, 413 45, Sweden
University Hospital Linköping, Department of Hematology
Linköping, 581 85, Sweden
Sunderbyn Hospital, Department of Medicine
Luleå, 971 80, Sweden
University Hospital Lund, Department of Oncology
Lund, 221 85, Sweden
Karolinska University Hospital, Department of Hematology
Stockholm, 171 76, Sweden
Sundsvall Hospital, Department of Medicine
Sundsvall, 851 86, Sweden
University Hospital of Norrland, Department of Oncology
Umeå, 981 85, Sweden
Uppsala University Hospital, Department of Oncology
Uppsala, 751 85, Sweden
Related Publications (1)
Albertsson-Lindblad A, Kolstad A, Laurell A, Raty R, Gronbaek K, Sundberg J, Pedersen LB, Ralfkiaer E, Karjalainen-Lindsberg ML, Sundstrom C, Ehinger M, Geisler C, Jerkeman M. Lenalidomide-bendamustine-rituximab in patients older than 65 years with untreated mantle cell lymphoma. Blood. 2016 Oct 6;128(14):1814-1820. doi: 10.1182/blood-2016-03-704023. Epub 2016 Jun 27.
PMID: 27354719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mats Jerkeman, MD, PhD
University Hospital Lund, Sweden
- STUDY DIRECTOR
Jan Sundberg, RN
University Hospital Lund, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 21, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
March 12, 2018
Record last verified: 2018-03