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

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	Eisai Inc. Genzyme
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00778375

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 II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia Myelodysplastic Syndromes

Drug Information available for: Cytarabine hydrochloride Clofarabine Cytarabine 5-Aza-2'-deoxycytidine

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Clofarabine + Cytarabine + Decitabine	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®

Arms

Assigned Interventions

Experimental: Clofarabine + Cytarabine + Decitabine

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:

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.
Age >/= 60 years.
ECOG performance status </= 2.
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).
Sign written informed consent

Exclusion Criteria:

Cardiac ejection fraction < 40%.
Prior therapy with clofarabine or decitabine.
Active and uncontrolled disease/infection as judged by the treating physician.
Pregnancy
Acute promyelocytic leukemia (APL).
Women of childbearing potential and men who do not practice contraception.
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

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

Investigators

Principal Investigator:

Stefan F. Faderl, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00778375 History of Changes
Other Study ID Numbers:	2007-0039
Study First Received:	October 21, 2008
Last Updated:	October 25, 2011
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, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Decitabine
Clofarabine

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012