Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

NCT01472562 | Completed Phase 2 Results

• 1 other identifier: 1103011566
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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.

Conditions

Mantle Cell Lymphoma

Keywords

mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

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

  30 months

Secondary Outcomes (4)

• Number of Participants With Progression-free Survival

  10 years

• Number of Participants With Overall 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

Study Arms (1)

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.

Drug: lenalidomide; Biological: rituximab

Interventions

lenalidomide DRUG

Induction phase: 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. Maintenance phase: Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.

Also known as: revlimid

all patients

rituximab BIOLOGICAL

Induction phase: 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: Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Also known as: rituxan

all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count \> = 1000 /mm³
• Platelet count \> = 75,000 /mm³
• Calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula • Total bilirubin \< = 2 x ULN
• AST (SGOT) and ALT (SGPT) \< = 3 x ULN.
• Disease free of prior malignancies for \> = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or localized prostate cancer.

You may not qualify if:

• 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.
• Patient has had major surgery within the last 3 weeks

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Celgene: collaborator

Study Sites (4)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Yamshon S, Chen GZ, Gribbin C, Christos P, Shah B, Schuster SJ, Smith SM, Svoboda J, Furman RR, Leonard JP, Martin P, Ruan J. Nine-year follow-up of lenalidomide plus rituximab as initial treatment for mantle cell lymphoma. Blood Adv. 2023 Nov 14;7(21):6579-6588. doi: 10.1182/bloodadvances.2023010606.

  PMID: 37682791 DERIVED

• Ruan J, Martin P, Christos P, Cerchietti L, Tam W, Shah B, Schuster SJ, Rodriguez A, Hyman D, Calvo-Vidal MN, Smith SM, Svoboda J, Furman RR, Coleman M, Leonard JP. Five-year follow-up of lenalidomide plus rituximab as initial treatment of mantle cell lymphoma. Blood. 2018 Nov 8;132(19):2016-2025. doi: 10.1182/blood-2018-07-859769. Epub 2018 Sep 4.

  PMID: 30181173 DERIVED

• Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. doi: 10.1056/NEJMoa1505237.

  PMID: 26535512 DERIVED

Related Links

• HemOnc clinical trials listing at Weill Cornell Medical College

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jia Ruan M.D, Ph.D
• Organization: Weill Cornell Medicine

amr2017@med.cornell.edu

646.962.2064

Study Officials

• Jia Ruan, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: November 16, 2011
• Study Start: July 29, 2011
• Primary Completion: April 1, 2014
• Study Completion: July 30, 2023
• Last Updated: July 16, 2024
• Results First Posted: April 7, 2017

Record last verified: 2024-07

Locations

US (4)