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Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma
This study has been completed.

First Received on September 10, 2005.   Last Updated on November 30, 2006   History of Changes
Sponsor: Celgene Corporation
Collaborator: Prologue Research International
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00179673
  Purpose

Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until for up to 52 weeks or until disease progression, subjects who achieve a 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


Condition Intervention Phase
Non-Hodgkins Lymphoma
Drug: CC-5013
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To determine the activity of lenalidiomide in relapsed or refractory indolent non-Hodgkin’s lymphoma. Activity will be assessed by measuring the response rate, tumor control rate, duration of response and progression free survival.

Secondary Outcome Measures:
  • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory indolent NHL.

Estimated Enrollment: 40
Study Start Date: June 2005
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age greater than or equla to18 years at the time of signing the informed consent form
  3. Able to adhere to the study visit schedule and other protocol requirements
  4. Biopsy-proven non-Hodgkin s lymphoma
  5. Indolent lymphoma the following histologies are acceptable: a. Follicular center lymphoma, grades 1, 2, b. Extranodal marginal zone B-cell lymphoma of MALT type, c. Nodal marginal zone B-cell lymphoma d. Splenic marginal zone B-cell lymphoma, e. Small lymphocytic lymphoma, f. Lymphoplasmacytoid lymphoma
  6. Relapsed or refractory to previous therapy for lymphoma. Subjects 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
  7. Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
  8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 (see Appendix II).
  9. 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.

Exclusion Criteria:

  1. Any of the following laboratory abnormalities

    1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
    2. Platelet count <100,000/mm3 (100 x 109/L)
    3. Serum creatinine >2.5 mg/dL (221 mmol/L)
    4. Serum SGOT/AST or SGPT/ALT >5.0 x upper limit of normal (ULN)
    5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)
  2. 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.
  3. All subjects with 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, CT scan or MRI, for at least 6 months.
  4. 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 subject has been free of the disease for > or equal to 1 year.
  5. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  6. Known positive for HIV.
  7. Pregnant or lactating females.
  8. Prior > or equal to grade 3 (Appendix III: NCI CTCAE) allergic reaction/hypersensitivity to thalidomide.
  9. Prior > or equal to³ grade 3 (Appendix III: NCI CTCAE) rash or any desquamating (blistering) rash while taking thalidomide.
  10. Prior use of lenalidomide.
  11. Use of any standard or experimental anti-cancer drug therapy within 28 days of day 1 of study drug therapy.
  12. Known active Hepatitis C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179673

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Alta Bates Cancer Center
Berkeley, California, United States, 94704
Pacific Coast Hematology/Oncology Medical Group, Onc.
Fountain Valley, California, United States, 92708
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Harvard University
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198-6805
United States, New York
New York Medical Center, MBCCOP
Bronx, New York, United States, 10466
United States, Ohio
Signal Point Hematology/Oncology
Middletown, Ohio, United States, 45042
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
United States, Wisconsin
Gunderson Clinic, Ltd.
La Crosse, Wisconsin, United States, 54601
Canada, British Columbia
BC Community Oncology Trialist
Burnaby, British Columbia, Canada, V5H 4K7
BC Community Oncology
North Vancouver, British Columbia, Canada, V7L 2P9
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179673     History of Changes
Other Study ID Numbers: CC-5013-NHL-001
Study First Received: September 10, 2005
Last Updated: November 30, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
NHL
CC5013
Non-Hodgkins Lymphoma
revlimid
cc-5013
celgene

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012