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Clinical trialNCT01457885CompletedPhase 2Interventional

Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen

SponsorUniversity of Michigan Rogel Cancer CenterEnrollment75Acute Myeloblastic Leukemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Although transplant results for AML in complete remission (CR) at the time of transplant have improved, transplant results for non-remission AML have been quite poor. Most multi-center studies have focused on standard risk AML patients and not many studies have been done in this population of patients with non-remission AML. There are a large number of older patients with non-remission AML because the complete remission rate with induction chemotherapy decreases with age. Such older patients do not tolerate conventional full intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for non-remission AML is a great unmet need for current transplant practice. From the investigators earlier study, it is suggested that replacing Fludarabine of standard FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in the transplant conditioning regimen may potentiate the anti-tumor activity of the conditioning regimen without adding significant toxicity, a goal of new conditioning regimen development. The investigators expect to enroll a total of 75 patients from about fifteen sites. The investigators main objective is to confirm both the safety and efficacy as measured by one-year overall survival, of the CloBu4 combination as full intensity conditioning for non-remission acute myelogenous leukemia.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Hospital for Sick Children

    Toronto, Ontario, Canada

  • Princess Margaret Hospital

    Toronto, Ontario, Canada

United States
  • University of Alabama, Birmingham

    Birmingham, Alabama, United States

  • City of Hope National Medical Center

    Duarte, California, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, United States

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, United States

  • Washington University at St Louis

    St Louis, Missouri, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • Vanderbuilt University

    Nashville, Tennessee, United States

  • University of Washington

    Seattle, Washington, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2011
Primary completion
30 Nov 2014
Completion
14 Jun 2016
Last update posted
2 Jun 2017
Registered enrollment
75
Registry id
NCT01457885

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.