The Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the side effects of the study drug, clofarabine, when given by mouth to patients with acute myeloid leukemia (AML), in remission.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Genzyme, a Sanofi Company; Loyola University; Rush University Medical Center; University of Illinois at Chicago
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

• Diagnosis of acute myeloid leukemia, in first or second remission.

• Age 55 or older

• Patients must have given signed, informed consent prior to registration on study.

• Participants must have attained a complete remission (CR) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant.

• Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.

• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria:

• Patients with a diagnosis of acute promyelocytic leukemia are not eligible.

• Participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy.

• Patients must not be receiving any other investigational agents.

• Participants cannot have Hepatitis B or C or HIV.

• Patients must not have an uncontrolled infection