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

This study has been withdrawn prior to enrollment.
(Due to funding issues.)
Sponsor:
Collaborators:
Loyola University
Rush University Medical Center
University of Illinois at Chicago
Genzyme, a Sanofi Company
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01065545
First received: February 8, 2010
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Drug: Clofarabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Determine the maximum tolerated dose of oral clofarabine. [ Time Frame: at study completion (estimated at 2 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure the relapse-free survival. [ Time Frame: labs drawn weekly (first cycle) and every other week thereafter until progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: June 2011
Arms Assigned Interventions
Experimental: Clofarabine Drug: Clofarabine
dose escalation, administered orally, once a day for 21 days per cycle (cycles begin every 28-49 days)
Other Names:
  • CLOLAR
  • CAFda
  • Cl-F-ara-A

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065545

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

No publications provided

Responsible Party: Jessica Altman, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT01065545     History of Changes
Other Study ID Numbers: NU 08H6, STU00008055
Study First Received: February 8, 2010
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
leukemia

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

ClinicalTrials.gov processed this record on November 27, 2014