Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline AML and High-Risk MDS

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eisai Inc.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00778375
First received: October 21, 2008
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.


Condition Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Drug: Clofarabine
Drug: Cytarabine
Drug: Decitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clofarabine Plus Low-Dose Cytarabine Induction Followed by Consolidation of Clofarabine Plus Low-Dose Cytarabine Alternating With Decitabine in Frontline AML and High-Risk MDS

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Disease-free (DFS) time and overall survival (OS) [ Time Frame: Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. ] [ Designated as safety issue: No ]
    Disease-free survival (DFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; and Overall survival (OS): Time from date of treatment start until date of death due to any cause.

  • Complete remission (CR) rate [ Time Frame: Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. ] [ Designated as safety issue: No ]
    Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 109/L and platelet count > 100 times 109/L, and normal bone marrow differential (< 5% blasts)


Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clofarabine + Cytarabine + Decitabine
Clofarabine 20 mg/m^2 by vein as a 1- to 2-hour intravenous infusion daily for 5 days. Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. Decitabine 20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
Drug: Clofarabine
20 mg/m^2 by vein as a 1- to 2-hour intravenous infusion daily for 5 days.
Other Names:
  • Clolar®
  • Clorarex
Drug: Cytarabine
20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions.
Other Names:
  • Cytosar-U®
  • Ara-C
  • Arabinosylcytosine
Drug: Decitabine
20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
Other Name: Dacogen®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously untreated AML and high-risk MDS (>/= 10% blasts or >/= IPSS intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.
  2. Age >/= 60 years.
  3. ECOG performance status </= 2.
  4. Adequate hepatic (serum total bilirubin </= 1.5 x ULN, SGPT and/or SGOT </= 2.5 x ULN) and renal function (creatinine </= 1.5 mg/dL).
  5. Sign written informed consent

Exclusion Criteria:

  1. Cardiac ejection fraction < 40%.
  2. Prior therapy with clofarabine or decitabine.
  3. Active and uncontrolled disease/infection as judged by the treating physician.
  4. Pregnancy
  5. Acute promyelocytic leukemia (APL).
  6. Women of childbearing potential and men who do not practice contraception.
  7. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778375

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Farhad Ravandi-Kashani, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00778375     History of Changes
Other Study ID Numbers: 2007-0039, NCI-2012-01622
Study First Received: October 21, 2008
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
AML
MDS
Clofarabine
Ara-C
Cytarabine
Decitabine

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions
Clofarabine
Cytarabine
Decitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014