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CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality
This study has been completed.
First Received: December 10, 2003   Last Updated: August 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00074126
  Purpose

RATIONALE: CC-5013 may slow the progression of myelodysplasia and allow the body to produce normal red blood cells.

PURPOSE: Phase II trial to study the effectiveness of CC-5013 in treating patients who require red blood cell transfusions for anemia caused by myelodysplastic syndrome associated with a cytogenetic abnormality.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: lenalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects With Myelodysplastic Syndromes Associated With a DEL (5q) Cytogenetic Abnormality

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2003
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of CC-5013, in terms of hematological improvement, in patients with red blood cell transfusion-dependent low- or intermediate-risk myelodysplastic syndromes and a del(5)(q31q33) cytogenetic abnormality.

Secondary

  • Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral CC-5013 on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of low- or intermediate-risk myelodysplastic syndromes (MDS) associated with a del(5)(q31q33) cytogenetic abnormality

    • Cytogenetic abnormality may be an isolated cytogenetic finding (the 5q- syndrome) OR may be associated with other cytogenetic abnormalities
  • Red blood cell (RBC) transfusion-dependent anemia defined as having received at least 2 units of RBCs within the past 8 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 500/mm^3
  • Platelet count at least 50,000/mm^3
  • No clinically significant anemia due to iron, B_12, or folate deficiency, autoimmune or hereditary hemolysis, or gastrointestinal bleeding
  • If marrow aspirate not evaluable for storage iron, the following criteria must be met:

    • Transferrin saturation at least 20%
    • Serum ferritin at least 50 ng/mL

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT no greater than 3.0 times upper limit of normal

Renal

  • Creatinine no greater than 2.5 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior grade 3 or greater allergic reaction or hypersensitivity to thalidomide
  • No prior grade 3 or greater rash or any desquamation (blistering) from thalidomide
  • No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study participation or giving informed consent or confound study results
  • No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior CC-5013
  • More than 7 days since prior hematopoietic growth factors
  • No concurrent epoetin alfa for MDS

Chemotherapy

  • More than 28 days since prior experimental or standard chemotherapy for MDS
  • No concurrent chemotherapy for MDS

Endocrine therapy

  • More than 28 days since prior chronic use (greater than 2 weeks in duration) of more than physiologic doses of corticosteroids
  • No concurrent androgens for MDS

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 28 days since prior experimental or standard immunosuppressive or cytoprotective agents for MDS
  • More than 28 days since other prior experimental or standard drugs or therapy for MDS
  • No other concurrent investigational agents for MDS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074126

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Stephen D. Nimer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
List AF, Dewald G, Bennett J, et al.: Hematologic and cytogenetic (CTG) response to lenalidomide (CC-5013) in patients with transfusion-dependent (TD) myelodysplastic syndrome (MDS) and chromosome 5q31.1 deletion: results of the multicenter MDS-003 study. [Abstract] J Clin Oncol 23 (Suppl 16): A-5, 2s, 2005.

Study ID Numbers: CDR0000343384, MSKCC-03085, CELGENE-CC-5013-MDS-003
Study First Received: December 10, 2003
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00074126     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes

Study placed in the following topic categories:
Preleukemia
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Lenalidomide
Chromosome Aberrations
Neoplasm Metastasis
Bone Marrow Diseases
Congenital Abnormalities

Additional relevant MeSH terms:
Disease
Precancerous Conditions
Hematologic Diseases
Antineoplastic Agents
Myelodysplastic Syndromes
Lenalidomide
Pharmacologic Actions
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses
Chromosome Aberrations
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 04, 2009