Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia

March 10, 2016 updated by: University of Michigan Rogel Cancer Center

Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia

The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals > 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

For Study Registration:

  • Age 55 - 70 years.
  • Subjects diagnosed with AML (> 20% myeloblasts).

For Proceeding to Transplant:

  • Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
  • Subjects must be > 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .

  • Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):

    • Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
    • Pulmonary: FEV1 and FVC > 40% predicted, DLCO > 40% of predicted.
    • Renal: Serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH).
    • Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN
    • Karnofsky > 60%.

  • Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):

    • Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
    • Pulmonary: FEV1 and FVC > 50% predicted, DLCO (corrected for hemoglobin) > 50% of predicted.
    • Renal: serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH)
    • Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN.
    • Karnofsky > 60%.

Exclusion Criteria:

For Study Registration:

  • Subjects with M3 AML (FAB classification)

For Proceeding to Transplant:

  • Subjects who exhibit signs of progressive disease (> 20% blasts) within 14 days prior to admission for transplant
  • Patients with an uncontrolled viral or fungal infection within the prior 28 days.
  • Patients who are HIV1 or HIV2 positive.
  • Uncontrollable medical or psychiatric disorder

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fludarabine plus Busulfan (CR)
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
Drug: Fludarabine
Fludarabine (40 mg/m2/day x 4 days)
Drug: Busulfan
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
Radiation: Total Body Irradiation
Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.
Procedure: Stem Cell Transplant
Allogeneic stem cell transplant from related or unrelated donor
Experimental: Fludarabine plus Busulfan (PR)
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
Drug: Fludarabine
Fludarabine (40 mg/m2/day x 4 days)
Drug: Busulfan
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
Procedure: Stem Cell Transplant
Allogeneic stem cell transplant from related or unrelated donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Relapse Free Survival at 1 Year
Time Frame: 1 year
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Alive at 1 Year
Time Frame: 1 year
One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Gregory Yanik, MD, University of Michigan Comprehesive Cancer Ctr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2006.065
  • HUM00006772 (Other Identifier: University of Michigan Medical School)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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