Suspended

A Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia

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What is being tested

clofarabine

+ cytarabine

+ filgrastim

DrugBiological
Who is being recruted

Congenital Abnormalities+6

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

From 18 to 75 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2009
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2009

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To test the ability of clofarabine + ara-C (cytarabine) to eliminate minimal residual (MRD) in acute myeloid leukemia (AML) patients whose bone marrows exhibit complete remission by morphology. SECONDARY OBJECTIVES: I. To determine the duration of complete remission after this treatment to minimize MRD. OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily (QD) on days 1-5 and clofarabine intravenously (IV) over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and then annually for 3 years.

Official TitleA Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia
NCT00863434
Principal SponsorUniversity of Washington
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesHematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

10 inclusion criteria required to participate
Diagnosis of AML by World Health Organization (WHO) criteria
Persistence of MRD by flow cytometry (phenotypic blast population detectable at >= 0.1% by flow cytometry despite < 5% blasts by morphology) after initial induction and one to four cycles of cytarabine containing consolidation chemotherapy
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Serum creatinine =< 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73m^2 as calculated by the Modification of Diet in Renal Disease equation, as reported by University of Washington Medical Center (UWMC) laboratory system
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12 exclusion criteria prevent from participating
Prior allogeneic stem cell transplant
Prior treatment with clofarabine
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry, with exceptions for oral agents such as FMS-like tyrosine kinase 3 (Flt3) Inhibitors or hydroxyurea which will be discontinued prior to the investigational drug regimen; intrathecal treatment within two weeks will also be allowed but not permitted to be given concurrently with investigational regimen
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, United StatesOpen Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium in Google Maps
SuspendedOne Study Center