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).

NCT00088218 | Completed Phase 2 Results

• 1 other identifier: 2004-0183
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Keywords

Acute Myeloid Leukemia; AML; High-Risk Myelodysplastic Syndrome; MDS; Clofarabine; Cytarabine; ara-C

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response

  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.

  Every 2 to 8 weeks

Study Arms (2)

Clofarabine

ACTIVE COMPARATOR

Clofarabine intravenous (IV) 30 mg/m\^2 daily times 5 days

Drug: Clofarabine

Clofarabine Plus Ara-C

ACTIVE COMPARATOR

Clofarabine IV 30 mg/m\^2 daily times 5 days + Ara-C 20 mg/m\^2 subcutaneously daily times 14 days.

Drug: Clofarabine; Drug: Ara-C

Interventions

Clofarabine DRUG

1-hour IV infusion 30 mg/m\^2 daily times 5 days (Days 1-5)

Also known as: Clolar, Clofarex

Clofarabine; Clofarabine Plus Ara-C

Ara-C DRUG

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).

Also known as: Cytarabine, Cytosar, DepoCyt, Cytosine arabinosine hydrocloride

Clofarabine Plus Ara-C

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Faderl S, Ravandi F, Huang X, Garcia-Manero G, Ferrajoli A, Estrov Z, Borthakur G, Verstovsek S, Thomas DA, Kwari M, Kantarjian HM. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood. 2008 Sep 1;112(5):1638-45. doi: 10.1182/blood-2007-11-124602. Epub 2008 Jun 18.

  PMID: 18565853 DERIVED

Related Links

• M.D. Anderson Cancer Center's website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Clofarabine; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Stefan Fader, M.D./Associate Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713/745-4613

Study Officials

• Stefan Faderl, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2004
• First Posted: July 23, 2004
• Study Start: July 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 7, 2012
• Results First Posted: May 9, 2011

Record last verified: 2011-04

Locations

US (1)