Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088218
Recruitment Status : Completed
First Posted : July 23, 2004
Results First Posted : May 9, 2011
Last Update Posted : August 7, 2012
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: Clofarabine Drug: Ara-C Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Phase II Study of Clofarabine Alone Versus Clofarabine in Combination With Low-Dose Cytarabine in Previously Untreated Patients >= 60 Years With AML and High-Risk MDS
Study Start Date : July 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Active Comparator: Clofarabine
Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
Drug: Clofarabine
1-hour IV infusion 30 mg/m^2 daily times 5 days (Days 1-5)
Other Names:
  • Clolar
  • Clofarex

Active Comparator: Clofarabine Plus Ara-C
Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
Drug: Clofarabine
1-hour IV infusion 30 mg/m^2 daily times 5 days (Days 1-5)
Other Names:
  • Clolar
  • Clofarex

Drug: Ara-C
20 mg/m^2 subcutaneously daily times 14 days (Days 1-14). On Days 1 to 5 of each course, clofarabine will precede injection of ara-C by approximately 4 hours (+/- 1 hour).
Other Names:
  • Cytarabine
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrocloride

Primary Outcome Measures :
  1. Number of Participants With Response [ Time Frame: Every 2 to 8 weeks ]

    Participant responses are categorized as 'Complete Remission,' Complete Remission, No Platelet Recovery,' 'No Response.'

    Complete Remission: Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 109/L and platelet count > 100 x 109/L, and normal bone marrow differential (< 5% blasts); Complete Remission, No Platelet Recovery: Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 109/L.

    Blood draws once a week until remission then every 2 to 8 weeks during therapy.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously untreated AML and high-risk MDS ( > 10% blasts, or International Prognostic Scoring System (IPSS) intermediate-2). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
  • Age > 60 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  • Sign a written informed consent form.
  • Adequate liver function (total bilirubin < 2mg/dL,serum glutamic pyruvic transaminase (SGPT) or Serum glutamic oxaloacetic transaminase (SGOT) < x 4 upper limit of normal (ULN)) and renal function (serum creatinine < 2mg/dL).

Exclusion Criteria:

  • Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088218

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Study Chair: Stefan Faderl, MD The University of Texas MD Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00088218     History of Changes
Other Study ID Numbers: 2004-0183
First Posted: July 23, 2004    Key Record Dates
Results First Posted: May 9, 2011
Last Update Posted: August 7, 2012
Last Verified: April 2011

Keywords provided by M.D. Anderson Cancer Center:
Acute Myeloid Leukemia
High-Risk Myelodysplastic Syndrome

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs