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

Genzyme

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: clofarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924443

BIOV-121

Details and patient eligibility

About

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.

Full description

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

Enrollment: 69 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Clofarabine

Experimental group

Description:

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.

Treatment:

Drug: clofarabine