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A Phase II Study of CC-5013 in Myelofibrosis
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: M.D. Anderson Cancer Center
Celgene Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00087672
  Purpose

The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also be studied.


Condition Intervention Phase
Myelofibrosis
Drug: CC-5013
Phase II

MedlinePlus related topics: Spleen Diseases
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of CC-5013 in Myelofibrosis

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To determine the efficacy of CC-5013 in myelofibrosis. [ Time Frame: July 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of CC-5013 in myelofibrosis. To determine the baseline levels of angiogenesis factors (TNF-alpha, VEGF, basic FGF) and correlate with outcome. [ Time Frame: July 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: July 2004
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
CC-5013
Drug: CC-5013
10 mg orally daily

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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Diagnosis of myelofibrosis or Philadelphia negative myeloproliferative disorder with myelofibrosis requiring therapy.
  • Disease-free of prior malignancies for greater than or equal to 2 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • ECOG performance status 0 to 3.
  • Total bilirubin less than or equal to 3.0 mg/dL (unless due to tumor) and serum creatinine less than or equal to 3.0 mg/dL (unless due to tumor).
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide 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. FCBP must also agree to ongoing pregnancy testing.
  • continued from above.....Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix K: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix I: Education and Counseling Guidance Document.
  • continued from above.....† A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Signed informed consent.

EXCLUSION CRITERIA

  • Use of any other experimental drug or therapy within 28 days of therapy, except in cases with rapidly progressive disease and/or recovery from all toxicity from previous therapy (does not apply to growth factors).
  • Platelet count less than 30,000.
  • Known prior clinically relevant hypersensitivity reaction or desquamating rash with thalidomide.
  • Prior therapy with CC-5013.
  • Pregnancy, suspected pregnancy or breast feeding females.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087672

Locations
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Jorge E Cortes, MD M.D. Anderson Cancer Center
  More Information

Website for The University of Texas M.D. Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes, M.D./ Professor )
Study ID Numbers: 2003-0648
Study First Received: July 12, 2004
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00087672  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Myelofibrosis
Phase 2

Study placed in the following topic categories:
Myeloid Metaplasia
Myelofibrosis-osteosclerosis
Lymphatic Diseases
Myelofibrosis
Hematologic Diseases
Metaplasia
Lenalidomide
Myeloproliferative Disorders
Bone Marrow Diseases

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Splenic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009