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

NCT ID: NCT01065545

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30

Brief 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.

Detailed Description

Standard induction chemotherapy (chemotherapy given with the intent of inducing a remission/disappearance of the cancer) can lead to a complete remission (CR) in a large percentage (60% to 80%) of younger patients with newly diagnosed AML. However, the majority of patients relapse (their disease returns) despite intensive consolidation chemotherapy. In most chemotherapy studies, only a small percentage (30% to 40%) of patients who achieve a CR still are disease-free 5 years later. The outcome for older adults is even less favorable. Approximately 75% of elderly patients who achieve CR will relapse after 2 years or less and the toxicities seen with treatment are significant. A number of studies have shown that chemotherapy given to older adults after a remission has not improved this outcome; therefore new treatments need to be investigated. Clofarabine is a drug that has been studied in older adults who have achieved a CR. The treatment was found to have fewer side effects then other consolidation therapies. This study will give participants the drug for a longer period of time to see if doing this will extend the cancer remission. Clofarabine has been approved by the FDA for the treatment of acute lymphoblastic leukemia (ALL), another form of acute leukemia. The study drug is considered experimental for AML because it has not been approved by the Food and Drug Administration (FDA) for the treatment of AML.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clofarabine

Group Type: EXPERIMENTAL

Clofarabine

Intervention Type: DRUG

dose escalation, administered orally, once a day for 21 days per cycle (cycles begin every 28-49 days)

Interventions

Clofarabine

dose escalation, administered orally, once a day for 21 days per cycle (cycles begin every 28-49 days)

Intervention Type: DRUG

Other Intervention Names

CLOLAR; CAFda; Cl-F-ara-A

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Northwestern University

Principal Investigators

Jessica Altman, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Other Identifiers

STU00008055

Identifier Type: OTHER

Identifier Source: secondary_id

NU 08H6

Identifier Type: -

Identifier Source: org_study_id