Mantle Cell LymphomaPhase 1/2LENA-BERITNCT00963534
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
A Phase 1/2 study testing lenalidomide, bendamustine, rituximab in people with Mantle Cell Lymphoma, run by Lund University Hospital at 17 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- lenalidomide, bendamustine, rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Sep 2009to Aug 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Sweden8 sites
Sahlgrenska University Hospital, Department of Hematology
Gothenburg, 413 45
University Hospital Linköping, Department of Hematology
Linköping, 581 85
Sunderbyn Hospital, Department of Medicine
Luleå, 971 80
University Hospital Lund, Department of Oncology
Lund, 221 85
Karolinska University Hospital, Department of Hematology
Stockholm, 171 76
Sundsvall Hospital, Department of Medicine
Sundsvall, 851 86
University Hospital of Norrland, Department of Oncology
Umeå, 981 85
Uppsala University Hospital, Department of Oncology
Uppsala, 751 85
Norway5 sites
Haukeland University Hospital, Department of Oncology
Bergen
Norwegian Radium Hospital
Oslo
Ulleval University Hospital, Department of Oncology
Oslo
University Hospital of Stavanger, Department of Haematology and Oncology
Stavanger
University Hospital of Tromso, Department of Oncology
Tromsø
Denmark3 sites
Århus University Hospital
Aarhus
Herlev Hospital
Copenhagen
Rigshospitalet, Department of Hematology
Copenhagen
About this study
Official title: Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial
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
Read the 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.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- lenalidomide, bendamustine, rituximab
- Keywords
- Mantle cell lymphoma, Lenalidomide, Bendamustine, Rituximab, Nordic Lymphoma Group, MTD for lenalidomide, Untreated patients, Patients with mantle cell lymphoma, age over 65 years
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomide, bendamustine, rituximabDrug
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, bendamustine, rituximabDrug
lenalidomide: day 1-21, maximum 13 cycles bendamustine: days 1-2, cycle 1-6 rituximab: day1, cycle 1-6
| Study group | Role | What they receive |
|---|---|---|
| lenalidomide, bendamustine, rituximab | Experimental | Not described Receives: Drug: lenalidomide, bendamustine, rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of lenalidomide (phase I) Progression free survival (phase II)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Pte Ltd., Celgene, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Mats Jerkeman, MD, PhD, Principal investigator, University Hospital Lund, SwedenJan Sundberg, RN, Study director, University Hospital Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963534
- Sponsor's protocol ID
- NLG-MCL4
- Acronym
- LENA-BERIT
- Status last verified
- Mar 2018
- First submitted
- 20 Aug 2009
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27354719
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial
- ClinicalTrials.gov ID
- NCT00963534
- Acronym / sponsor ID
- LENA-BERIT / NLG-MCL4
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Mundipharma Pte Ltd., Celgene, Roche Pharma AG
- Study start
- Sep 2009 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lenalidomide, bendamustine, rituximab | Experimental | Drug: lenalidomide, bendamustine, rituximab |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomide, bendamustine, rituximabPhase 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, bendamustine, rituximablenalidomide: day 1-21, maximum 13 cycles bendamustine: days 1-2, cycle 1-6 rituximab: day1, cycle 1-6 | Drug | lenalidomide, bendamustine, rituximab |
Primary outcome
MTD of lenalidomide (phase I) Progression free survival (phase II)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Derived from this study: PubMed 27354719Albertsson-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats Jerkeman, MD, PhD principal investigator
University Hospital Lund, Sweden
Jan Sundberg, RN study director
University Hospital Lund, Sweden
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lenalidomide, bendamustine, rituximab in people with Mantle Cell Lymphoma, run by Lund University Hospital at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Sweden, Norway, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD of lenalidomide (phase I) Progression free survival (phase II) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00963534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.