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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065545
Recruitment Status : Withdrawn (Due to funding issues.)
First Posted : February 9, 2010
Last Update Posted : April 10, 2015
Loyola University
Rush University Medical Center
University of Illinois at Chicago
Genzyme, a Sanofi Company
Information provided by:
Northwestern University

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Clofarabine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Feasibility Study Assessing the Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia
Study Start Date : June 2011

Arm Intervention/treatment
Experimental: Clofarabine Drug: Clofarabine
dose escalation, administered orally, once a day for 21 days per cycle (cycles begin every 28-49 days)
Other Names:
  • CAFda
  • Cl-F-ara-A

Primary Outcome Measures :
  1. Determine the maximum tolerated dose of oral clofarabine. [ Time Frame: at study completion (estimated at 2 years) ]

Secondary Outcome Measures :
  1. Measure the relapse-free survival. [ Time Frame: labs drawn weekly (first cycle) and every other week thereafter until progression ]

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065545

Sponsors and Collaborators
Northwestern University
Loyola University
Rush University Medical Center
University of Illinois at Chicago
Genzyme, a Sanofi Company
Principal Investigator: Jessica Altman, MD Northwestern University

Responsible Party: Jessica Altman, MD, Northwestern University Identifier: NCT01065545     History of Changes
Other Study ID Numbers: NU 08H6
STU00008055 ( Other Identifier: Northwestern University IRB )
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Northwestern University:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents