NCT01065545

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

First QC Date

February 8, 2010

Last Update Submit

April 9, 2015

Conditions

Acute Myeloid Leukemia

Keywords

leukemia

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose of oral clofarabine.

    at study completion (estimated at 2 years)

Secondary Outcomes (1)

  • Measure the relapse-free survival.

    labs drawn weekly (first cycle) and every other week thereafter until progression

Study Arms (1)

Clofarabine

EXPERIMENTAL
Drug: Clofarabine

Interventions

ClofarabineDRUG

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

Also known as: CLOLAR, CAFda, Cl-F-ara-A
Clofarabine

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesNucleotidesRibonucleotides

Study Officials

  • Jessica Altman, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

June 1, 2011

Last Updated

April 10, 2015

Record last verified: 2015-04