Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00044889

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed < one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia	Drug: clofarabine (IV formulation)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II, Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Study Start Date :

May 1, 2002

Actual Study Completion Date :

Mar 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
Diagnosis of AML according to FAB classification
Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory
A Karnofsky Performance Status (KPS) of greater than or equal to 60.
If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
Signed, written informed consent.
Ability to comply with study procedures and follow-up examinations.
Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration.
Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study.

Exclusion Criteria:

note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
Received previous treatment with CLOFARABINE.
Received more than two previous induction regimens or cycles for the treatment of AML.
Relapsed > 1 year.
Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
Are pregnant or lactating.
Have psychiatric disorders that would interfere with consent, study participation or follow-up.
Are receiving any other chemotherapy or corticosteroids. Patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
Have any other severe concurrent disease.
Have symptomatic CNS involvement.
Have chronic myelogenous leukemia (CML) in lymphoid blast crisis).

Contacts and Locations

Locations

	City	State	Country
1	Los Angeles	California	United States
2	Washington	District of Columbia	United States
3	Jacksonville	Florida	United States
4	Chicago	Illinois	United States
5	St. Louis	Missouri	United States
6	Omaha	Nebraska	United States
7	Buffalo	New York	United States
8	Durham	North Carolina	United States
9	Memphis	Tennessee	United States
10	Houston	Texas	United States
11	Norfolk	Virginia	United States
12	Seattle	Washington	United States