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A Multicenter, Single-Arm, Open-Label Study Of The Efficacy And Safety Of CC-5013 Monotherapy In RBC Transfusion-Dependent Subjects With Myelodysplastic Syndromes


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

A Multicenter, Single-Arm, Open-Label Study Of The Efficacy And Safety Of CC-5013 Monotherapy In RBC Transfusion-Dependent Subjects With Myelodysplastic Syndromes


OBJECTIVES:

Primary

- Determine the efficacy of CC-5013, in terms of hematopoietic improvement, in patients
with transfusion-dependent low- or intermediate-1-risk myelodysplastic syndromes.

Secondary

- Determine the safety of this drug in these patients.

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

Patients receive oral CC-5013 once daily on days 1-28. Treatment repeats every 28 days for
up to 24 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 136 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of low- or intermediate-1-risk myelodysplastic syndromes (MDS)

- No abnormality of chromosome 5 involving a deletion between bands q31 and q33

- Red blood cell (RBC) transfusion-dependent, defined as having received at least 2
units of RBCs within the past 8 weeks

- No proliferative (WBC ≥ 12,000/mm^3) chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count ≥ 500/mm^3

- Platelet count ≥ 50,000/mm^3

- No clinically significant anemia due to iron, B_12, or folate deficiencies,
autoimmune or hereditary hemolysis, or gastrointestinal bleeding* NOTE: *If a marrow
aspirate is not evaluable for storage iron, transferrin saturation must be ≥ 20% AND
ferritin ≥ 50 ng/mL

Hepatic

- AST and ALT ≤ 3.0 times upper limit of normal

- Bilirubin ≤ 2.0 mg/dL

Renal

- Creatinine ≤ 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 while taking thalidomide

- No other malignancy within the past 3 years except basal cell or squamous cell cancer
or carcinoma in situ of the cervix or breast

- No other serious medical condition, laboratory abnormality, or psychiatric illness
that would preclude giving informed consent or participating in the study

- Able to aspirate bone marrow

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior CC-5013

- More than 7 days since prior hematopoietic growth factors

- No concurrent red blood cell hematopoietic growth factors (e.g., epoetin alfa)

Chemotherapy

- More than 28 days since prior chemotherapy for MDS

- No concurrent chemotherapy for MDS

Endocrine therapy

- More than 28 days since prior chronic use (more than 2 weeks) of more than
physiologic doses of corticosteroids (dose equivalent to more than 10 mg/day of
prednisone)

- No concurrent corticosteroids except steroids for adrenal failure, hormones for
non-cancer-related conditions (e.g., insulin for diabetes), or intermittent
dexamethasone as an antiemetic

- No concurrent androgens

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 28 days since prior standard (i.e., immunosuppressive or cytoprotective
agents) therapy for MDS

- More than 28 days since prior experimental therapy

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Virginia Klimek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000352173

NCT ID:

NCT00077506

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • chronic myelomonocytic leukemia
  • previously treated myelodysplastic syndromes
  • de novo myelodysplastic syndromes
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • secondary myelodysplastic syndromes
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • Neoplasms
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021