2 Arm Study of Clofarabine IV in MDS Patients

NCT00422032 | Completed Phase 2 Results DMC

• 1 other identifier: 2005-0535
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared. Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS. Secondary Objective: Compare response durations, survivals and side effects of the two schedules.

Conditions

Myelodysplastic Syndrome; Leukemia

Keywords

Myelodysplastic Syndrome; Leukemia; Clofarabine; MDS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response for Two Dose Schedules of Clofarabine

  Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils \>/= 1 \* 10\^9/L and platelet counts \>/= 100 \* 10\^9/L, and marrow blasts \</=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to \>/= 100 \* 10\^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).

  4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)

Study Arms (2)

15 mg/m^2 Clofarabine

EXPERIMENTAL

Lower Dose Clofarabine Group A: 15 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days

Drug: Clofarabine

30 mg/m^2 Clofarabine

EXPERIMENTAL

Higher Dose Clofarabine Group B: 30 mg/m\^2 IV over 1 hour daily for 5 days

Drug: Clofarabine

Interventions

Clofarabine DRUG

Group A: 15 mg/m\^2 IV over 1 hour daily for 5 days Group B: 30 mg/m\^2 IV over 1 hour daily for 5 days

Also known as: Clolar

15 mg/m^2 Clofarabine; 30 mg/m^2 Clofarabine

Eligibility Criteria

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

You may qualify if:

• Patients with MDS and \>/= 5% blasts or International Prognostic Scoring System (IPSS) risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (CMML).
• No prior intensive chemotherapy or high-dose ara-C (\> 1g/m2).
• Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
• Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
• Hydroxyurea is permitted for control of counts prior to treatment.
• Procrit, GCSF are allowed before therapy.
• Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate organ function including the following: Adequate liver function (bilirubin of \< 2mg/dl), and renal function (creatinine \< 2mg/dl), and SGPT (ALT) \< 3 \* upper limit of normal (ULN). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded).
• Signed informed consent.

You may not qualify if:

• Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Active and uncontrolled infections.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
• Prior clofarabine treatment.

Sponsors & Collaborators

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

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson's Website

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

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

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

Results Point of Contact

• Title: Hagop Kantarjian, MD / Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-792-7026

Study Officials

• Hagop Kantarjian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 15, 2007
• Study Start: January 1, 2006
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 27, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-06

Locations

US (1)