A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

Study Overview
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Brief Summary
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The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.

Detailed Description
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Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

Official Title
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A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: clofarabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed, written informed consent Have untreated AML according to World Health Organization (WHO) classification Male or post-menopausal female ≥ 65 years of age Unsuitable for intensive chemotherapy Be able to comply with study procedures and follow-up examination Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies Have adequate liver and renal function as indicated by certain laboratory values Exclusion Criteria: Received previous treatment with clofarabine Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed) Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine Have a psychiatric disorder that would interfere with consent, study participation, or follow-up Have an active, uncontrolled systemic infection Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days Have symptomatic central nervous system (CNS) involvement Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clofarabine<br>Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles. | Drug: clofarabine<br> <br> * Other names: tradename EU = Evoltra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population. ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment. | At month 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial) | Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment. | At month 20 | 
| Duration of Overall Response | Duration was calculated by Kaplan-Meier estimates | From 20 months up to 48 months | 
| Overall Survival | Calculated by Kaplan-Meier estimates | From 20 months up to 48 months | 
| Duration of Complete Remission | Duration was calculated by Kaplan- Meier estimates | From 20 months up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myelogenous leukemia, acute myeloid leukemia, clolar, evoltra, clofarabine, untreated acute leukemia, adult acute leukemia