A Phase II Study of CC-5013 in Myelofibrosis

NCT00087672 | Completed Phase 2 Results

• 1 other identifier: 2003-0648
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelofibrosis

Keywords

Myelofibrosis; Philadelphia negative myeloproliferative disorder; CC-5013; Lenalidomide; Revlimid; Antiangiogenesis

Outcome Measures

Primary Outcomes (1)

• Efficacy of CC-5013 in Myelofibrosis

  Response evaluation, sustained for 2 weeks: Complete Remission (Neutrophil count between 1 to 10 x 10\^9/L without peripheral blasts in blood or bone marrow); Partial Hematologic Response/Partial Remission (Increase in neutrophil by 50% + above 10\^9/L for neutropenia); Hematologic Improvement (increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts) or No Response. If nine or \< patients respond to therapy (response other than 'No Response'), therapy declared ineffective. However, if 11 or \> patients respond to therapy, therapy considered efficacious.

  3 - 4 Months for all patients; 24 months for responders

Study Arms (1)

CC-5013

EXPERIMENTAL

Drug: CC-5013

Interventions

CC-5013 DRUG

10 mg orally (2 capsules) daily

Also known as: lenalidomide, Revlimid

CC-5013

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Website for The University of Texas M.D. Anderson Cancer Center

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic 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: Jorge Cortes, M.D./ Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-794-5783

Study Officials

• Jorge E Cortes, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 12, 2004
• First Posted: July 14, 2004
• Study Start: July 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 7, 2012
• Results First Posted: February 21, 2011

Record last verified: 2012-08

Locations

US (1)