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A Phase I Feasibility Study Assessing the Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia

Phase 1
55 Years
Not Enrolling
Acute Myeloid Leukemia

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Trial Information

A Phase I Feasibility Study Assessing the Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose of oral clofarabine.

Outcome Time Frame:

at study completion (estimated at 2 years)

Safety Issue:


Principal Investigator

Jessica Altman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 08H6



Start Date:

June 2011

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid