Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

NCT00179673 | Completed Phase 2 Results

• 1 other identifier: CC-5013-NHL-001
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 15

Brief Summary

Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28-day cycle. Treatment will continue for up to 52 weeks or until disease progression; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progression free survival following discontinuation from the treatment phase

Conditions

Non-Hodgkins Lymphoma

Keywords

NHL; CC5013; Non-Hodgkins Lymphoma; revlimid; cc-5013; celgene

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response

  Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. Cru: Criteria for CR above but with 1 or more of the following: • A residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) • Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.

  From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

Secondary Outcomes (4)

• Percentage of Participants With Tumor Control

  From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

• The Duration of Response

  From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

• Progression Free Survival (PFS)

  From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

• Number of Participants With Adverse Events (AEs)

  From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Also known as: Revlimid, CC-5013

Lenalidomide

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 greater than or equal to 18 years at the time of signing the informed consent form
• Able to adhere to the study visit schedule and other protocol requirements
• Biopsy-proven non-Hodgkin's lymphoma
• Indolent lymphoma the following histologies are acceptable: a. Follicular center lymphoma, grades 1, 2; b. Extranodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT) type, c. Nodal marginal zone B-cell lymphoma d. Splenic marginal zone B-cell lymphoma, e. Small lymphocytic lymphoma (SLL), f. Lymphoplasmacytoid lymphoma
• Relapsed or refractory to previous therapy for lymphoma. Participants must have received at least one prior treatment regimen such as radiation, immunotherapy, chemotherapy, or radioimmunotherapy, and be ineligible or unwilling to undergo an autologous stem cell transplant. There is no limit on the number of prior therapies
• Participants must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

You may not qualify if:

• Any of the following laboratory abnormalities
• Absolute neutrophil count (ANC) \<1,500 cells/mm\^3 (1.5 x 10\^9/L)
• Platelet count \<100,000/mm\^3 (100 x 10\^9/L)
• Serum creatinine \>2.5 mg/dL (221 mmol/L)
• Serum Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) \>5.0 x upper limit of normal (ULN)
• Serum total bilirubin \>2.0 mg/dL (34 mmol/L)
• Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• All participants with Central Nervous System (CNS) disease with the exception of those subjects whose CNS disease has been treated with chemotherapy, radiotherapy or surgery and remains asymptomatic, with no active CNS disease, as shown by lumbar puncture, computerized tomography (CT) scan or Magnetic resonance imaging (MRI), for at least 6 months.
• Prior history of malignancies other than non-Hodgkin's lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the participant has been free of the disease for \> or equal to 1 year.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from signing the informed consent form.
• Known positive for human immunodeficiency virus (HIV).
• Pregnant or lactating females.
• Prior \> or equal to grade 3 allergic reaction/hypersensitivity to thalidomide.
• Prior \> or equal to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
• Prior use of lenalidomide.

Sponsors & Collaborators

• Celgene: lead
• Prologue Research International: collaborator

Study Sites (15)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Alta Bates Cancer Center

Berkeley, California, 94704, United States

Location

Pacific Coast Hematology/Oncology Medical Group, Onc.

Fountain Valley, California, 92708, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Harvard University

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska

Omaha, Nebraska, 68198-6805, United States

Location

New York Medical Center, MBCCOP

The Bronx, New York, 10466, United States

Location

Signal Point Hematology/Oncology

Middletown, Ohio, 45042, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Gunderson Clinic, Ltd.

La Crosse, Wisconsin, 54601, United States

Location

BC Community Oncology Trialist

Burnaby, British Columbia, V5H 4K7, Canada

Location

BC Community Oncology

North Vancouver, British Columbia, V7L 2P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Manager, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

888-260-1599

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 13, 2025
• Results First Posted: October 14, 2013

Record last verified: 2025-05

Locations

US (11); CA (4)