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Clinical Trials/NCT01472562
NCT01472562
Completed
Phase 2

Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Weill Medical College of Cornell University4 sites in 1 country38 target enrollmentStarted: July 29, 2011Last updated:
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ConditionsMantle Cell Lymphoma
Interventionslenalidomiderituximab
Drugslenalidomide

Overview

Phase
Phase 2
Status
Completed
Enrollment
38
Locations
4
Primary Endpoint
Overall Response Rate
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This is a phase II, multicenter study to determine the efficacy and safety of first-line lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received no prior systemic therapy.

Detailed Description

Induction Phase (week 1 - 48):

  • Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
  • Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance Phase (week 49 - progression of disease):

  • Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
  • Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Response Assessment

  • Year 1-2: Conventional restaging CT scan (or MRI) with IV contrast every 3 months from cycle 1 day 1 of the study.
  • Year 3 onwards: Conventional restaging CT scan (or MRI) with IV contrast every 6 months until progression.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Understand and voluntarily sign an informed consent form.
  • •Age \> = 18 years at the time of signing the informed consent form.
  • •Able to adhere to the study visit schedule and other protocol requirements.
  • •Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with cyclin D1 overexpression by immunohistochemistry, and a characteristic immunophenotypic profile with CD5(+), CD23(-), CD20(+), and CD10(-). In tumor tissues with negative cyclin D1, evidence of cyclin D2 or D3 overexpression by immunohistochemistry will be acceptable.
  • •No prior systemic therapy for lymphoma including chemotherapy or immunotherapy. Patients may have received involved-field radiation therapy which has been discontinued at least 4 weeks prior to treatment in this study.
  • •Patient has measurable disease as defined by a tumor mass \> 1.5 cm in one dimension.
  • •Low and intermediate-risk disease as defined by MIPI score.
  • •Subject who the investigator considers that chemotherapy is not indicated.
  • •ECOG performance status of \< = 2 at study entry.
  • •Laboratory test results within these ranges:

Exclusion Criteria

  • •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • •Pregnant or breast feeding females.
  • •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • •Use of any other experimental drug or therapy within 28 days of baseline.
  • •Patient on corticosteroids within two weeks prior to study entry, except for prednisone \< = 10 mg/day or equivalent for purposes other than treating MCL.
  • •Known hypersensitivity to thalidomide.
  • •Any prior use of lenalidomide.
  • •Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
  • •Known central nervous system (CNS) involvement by lymphoma.
  • •Patient at high risk for deep vein thrombosis not willing to take DVT prophylaxis.

Arms & Interventions

all patients

Experimental

Induction Phase (week 1 - 48):

  • Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
  • Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance Phase (week 49 - progression of disease):

  • Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
  • Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Intervention: lenalidomide (Drug)

all patients

Experimental

Induction Phase (week 1 - 48):

  • Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
  • Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance Phase (week 49 - progression of disease):

  • Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
  • Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Intervention: rituximab (Biological)

Outcomes

Primary Outcomes

Overall Response Rate

Time Frame: 30 months

The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.

Secondary Outcomes

  • Number of Participants With Progression-free Survival(10 years)
  • Time to Next Treatment(10 years)
  • Safety as Measured by Number of Subjects Who Experience an Adverse Event While on Study Treatment(6 years)
  • Number of Participants With Overall Survival(10 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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