Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma

NCT00478959 | Completed Phase 2

• 1 other identifier: CC-5013-HL
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.

Conditions

Hodgkin Disease

Keywords

Lenalidomide; Revlimid; Hodgkin's; Hodgkin; Hodgkin's Lymphoma; Hodgkin's Disease; Lymphoma

Outcome Measures

Primary Outcomes (1)

• To assess the response rate (CR + CRu + PR) of Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma

  CT scans performed every two months while on therapy

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma.

Drug: Lenalidomide (Revlimid®)

Interventions

Lenalidomide (Revlimid®) DRUG

25mg PO daily for 21 out of 28days per cycle

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed Hodgkin's lymphoma that is relapsed or refractory (repeat biopsy is not mandatory) and is no longer eligible for curative treatment
• \</=3 prior chemotherapy regimens (in patients without a prior ASCT)
• Patients with disease progression after ASCT will be eligible if they have received \</= 1 additional chemotherapy regimen post-ASCT
• ECOG Performance Status 0-2
• Adequate hematological function:
• Absolute granulocyte count \> 1.0 x 10 to the 9/L
• Platelet count \> 75 x 10 to the 9/L
• Adequate renal and hepatic functions:
• Serum creatinine \< 1.25 x UNL or a calculated creatinine clearance \> 50 mL/min
• Serum bilirubin \< 1.5 x UNL and AST/ALT \< 3 x UNL
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. (See Appendix B Pregnancy Testing Guidelines and Acceptable Birth Control Methods.)
• Able to take aspirin (325 mg daily) as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
• Written Informed Consent must be given according to ICH/GCP and national/local regulations

You may not qualify if:

• Prior treatment with Lenalidomide or Thalidomide
• Use of any other experimental therapy within the 28 days prior to baseline assessment
• Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C
• Pregnant or Lactating women
• Other significant medical problems such as uncontrolled hypertension, uncontrolled psychiatric symptoms disorders, serious infections, active peptic ulcer disease, or any other medical conditions that might be aggravated by treatment
• Second malignancy in the past five years with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
• Concurrent use of other anti-cancer agents or treatments.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Celgene Corporation: collaborator

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

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

Study Officials

• John Kuruvilla

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

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: May 24, 2007
• First Posted: May 25, 2007
• Study Start: December 1, 2006
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 18, 2020

Record last verified: 2020-09