Clofarabine Combinations in Relapsed/Refractory AML, MDS and Myeloid Blast Phase CML - Full Text View

Purpose

The goal of this clinical research study is to find the best safe dose for 2 different drug combinations. For this purpose, participants will either receive the combination of clofarabine plus idarubicin or clofarabine plus idarubicin and ara-C. Once the best safe dose for these drug combinations are found, the next goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with AML, high-grade MDS, or myeloid blast phase of CML who have relapsed following their initial therapy. The safety of these treatments will also be studied.

Condition	Intervention	Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Chronic Myeloid Leukemia	Drug: Clofarabine Drug: Idarubicin Drug: Ara-C	Phase II

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

ChemIDplus related topics:

Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride Clofarabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Prospective Randomized Ph I/II Study of Clofarabine + Ara-C vs Clofarabine + Idarubicin vs Clofarabine + Idarubicin + Ara-C in Patients With 1st Relapse or 1st Salvage of Primary Refractory(AML); and High-Grade (MDS) (>/= 10% Blasts); or With (CML) in Myeloid Blasts Phase as Front Line Therapy or in First Salvage.)

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

Primary Outcome Measures:

To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of clofarabine plus idarubicin, and clofarabine plus idarubicin and ara-C. [ Time Frame: July 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the complete response rate (CR and CRp) of clofarabine plus idarubicin and ara-C vs clofarabine and ara-C vs clofarabine and idarubicin. The primary efficacy endpoint will be success defined as the number of patients achieving CR/CRp. [ Time Frame: July 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	136
Study Start Date:	December 2003
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clofarabine + Ara-C	Drug: Clofarabine Clofarabine 40mg/m2 IV over 1h Drug: Ara-C Ara-C 1g/m2 IV over 2h
2: Experimental Clofarabine + Idarubicin	Drug: Clofarabine Clofarabine 40mg/m2 IV over 1h Drug: Idarubicin Idarubicin Drug: Ara-C Ara-C 1g/m2 IV over 2h
3: Experimental Clofarabine + Idarubicin + Ara-C	Drug: Clofarabine Clofarabine 40mg/m2 IV over 1h Drug: Idarubicin Idarubicin Drug: Ara-C Ara-C 1g/m2 IV over 2h

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Age >/= 18 years
Must be in first relapse of AML, or must receive treatment as first salvage in primary refractory AML; or have high-risk MDS (>/= 10% blasts) with not more than one prior regimen of chemotherapy (therapy with hematopoietic growth factors, biological or targeted therapies are not counted). Patients in CML myeloid blast phase may receive clofarabine as frontline therapy or in first salvage.
Total bilirubin </= 2mg/dL, SGPT </= 4 ULN, creatinine </= 2.0mg/dL.
ECOG performance status </= 2.
Signed informed consent.
Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as >= 1 year postmenopausal or surgically sterilized).

Exclusion:

Previous treatment with clofarabine.
Active, uncontrolled, systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment, or any severe, concurrent disease, which, in the judgment of the investigator and after discussion with the Principal Investigator, would make the patient inappropriate for study entry.
Symptomatic CNS involvement.
Patients who receive other chemotherapy. Patients must have been off previous therapy of >/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier following discussion with the Principal Investigator.
Cardiac ejection fraction </= 30%.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067028

Contacts


Contact: Stefan H Faderl, MD	713-745-4613	sfaderl@mdanderson.org

Locations


United States, Texas
	M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Contact: Stefan H Faderl, MD 713-745-4613 sfaderl@mdanderson.org
	Contact: Hagop M Kantarjian, MD 713-792-7026 hkantarj@mdanderson.org

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genzyme

Investigators


Principal Investigator:	Stefan H Faderl, MD	M.D. Anderson Cancer Center

More Information

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

Responsible Party:	The University of Texas M. D. Anderson Cancer Center ( Stefan Faderl M.D./Associate Professor )
Study ID Numbers:	ID03-0181
First Received:	August 8, 2003
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00067028
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Myeloid Leukemia

CML Myeloid Blast Phase

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Clofarabine

Ara-C

Idarubicin

Study placed in the following topic categories:

Clofarabine

Myelodysplastic syndromes

Blast Crisis

Precancerous Conditions

Chronic myelogenous leukemia

Hematologic Diseases

Myelodysplasia

Myelodysplastic Syndromes

Acute myelogenous leukemia

Myeloproliferative Disorders

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia

Idarubicin

Preleukemia

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Bone Marrow Diseases

Acute myelocytic leukemia

Cytarabine

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Neoplasms by Histologic Type

Disease

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Antibiotics, Antineoplastic

Immunosuppressive Agents

Antiviral Agents

Pharmacologic Actions

Neoplasms

Neoplastic Processes

Pathologic Processes

Syndrome

Therapeutic Uses

Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on September 04, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center Genzyme
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00067028