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Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial


Phase 1/Phase 2
65 Years
N/A
Open (Enrolling)
Both
Mantle Cell Lymphoma

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Trial Information

Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mats Jerkeman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Lund, Sweden

Authority:

Sweden: Medical Products Agency

Study ID:

NLG-MCL4

NCT ID:

NCT00963534

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle cell lymphoma
  • Lenalidomide
  • Bendamustine
  • Rituximab
  • Nordic Lymphoma Group
  • MTD for lenalidomide
  • Untreated patients
  • Patients with mantle cell lymphoma, age over 65 years
  • Lymphoma
  • Lymphoma, Mantle-Cell

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