search
Back to results

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

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
lenalidomide, bendamustine, rituximab
lenalidomide, bendamustine, rituximab
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle cell lymphoma, Lenalidomide, Bendamustine, Rituximab, Nordic Lymphoma Group, MTD for lenalidomide, Untreated patients, Patients with mantle cell lymphoma, age over 65 years

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev Hospital
  • Rigshospitalet, Department of Hematology
  • Århus University Hospital
  • Helsinki University Central Hospital
  • Haukeland University Hospital, Department of Oncology
  • Norwegian Radium Hospital
  • Ulleval University Hospital, Department of Oncology
  • University Hospital of Stavanger, Department of Haematology and Oncology
  • University Hospital of Tromso, Department of Oncology
  • Sahlgrenska University Hospital, Department of Hematology
  • University Hospital Linköping, Department of Hematology
  • Sunderbyn Hospital, Department of Medicine
  • University Hospital Lund, Department of Oncology
  • Karolinska University Hospital, Department of Hematology
  • Sundsvall Hospital, Department of Medicine
  • University Hospital of Norrland, Department of Oncology
  • Uppsala University Hospital, Department of Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lenalidomide, bendamustine, rituximab

Arm Description

Outcomes

Primary Outcome Measures

MTD of lenalidomide (phase I) Progression free survival (phase II)

Secondary Outcome Measures

Full Information

First Posted
August 20, 2009
Last Updated
March 9, 2018
Sponsor
Lund University Hospital
Collaborators
Mundipharma Pte Ltd., Celgene, Roche Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00963534
Brief Title
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
Acronym
LENA-BERIT
Official Title
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
Collaborators
Mundipharma Pte Ltd., Celgene, Roche Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
Mantle cell lymphoma, Lenalidomide, Bendamustine, Rituximab, Nordic Lymphoma Group, MTD for lenalidomide, Untreated patients, Patients with mantle cell lymphoma, age over 65 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lenalidomide, bendamustine, rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lenalidomide, bendamustine, rituximab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
lenalidomide, bendamustine, rituximab
Intervention Description
lenalidomide: day 1-21, maximum 13 cycles bendamustine: days 1-2, cycle 1-6 rituximab: day1, cycle 1-6
Primary Outcome Measure Information:
Title
MTD of lenalidomide (phase I) Progression free survival (phase II)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Jerkeman, MD, PhD
Organizational Affiliation
University Hospital Lund, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Sundberg, RN
Organizational Affiliation
University Hospital Lund, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Herlev Hospital
City
Copenhagen
Country
Denmark
Facility Name
Rigshospitalet, Department of Hematology
City
Copenhagen
Country
Denmark
Facility Name
Århus University Hospital
City
Århus
Country
Denmark
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Haukeland University Hospital, Department of Oncology
City
Bergen
Country
Norway
Facility Name
Norwegian Radium Hospital
City
Oslo
Country
Norway
Facility Name
Ulleval University Hospital, Department of Oncology
City
Oslo
Country
Norway
Facility Name
University Hospital of Stavanger, Department of Haematology and Oncology
City
Stavanger
Country
Norway
Facility Name
University Hospital of Tromso, Department of Oncology
City
Tromso
Country
Norway
Facility Name
Sahlgrenska University Hospital, Department of Hematology
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
University Hospital Linköping, Department of Hematology
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Sunderbyn Hospital, Department of Medicine
City
Luleå
ZIP/Postal Code
971 80
Country
Sweden
Facility Name
University Hospital Lund, Department of Oncology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska University Hospital, Department of Hematology
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Sundsvall Hospital, Department of Medicine
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
University Hospital of Norrland, Department of Oncology
City
Umeå
ZIP/Postal Code
981 85
Country
Sweden
Facility Name
Uppsala University Hospital, Department of Oncology
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27354719
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs