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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00623935
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : July 17, 2014
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: Fludarabine Drug: Busulfan Radiation: Total Body Irradiation Procedure: Stem Cell Transplant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Study Start Date : March 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : November 2015

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623935


Locations
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United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Gregory Yanik, MD University of Michigan Comprehesive Cancer Ctr
More Information
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00623935    
Other Study ID Numbers: UMCC 2006.065
HUM00006772 ( Other Identifier: University of Michigan Medical School )
First Posted: February 26, 2008    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: April 8, 2016
Last Verified: March 2016
Keywords provided by University of Michigan Rogel Cancer Center:
AML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Busulfan
Antineoplastic Agents
 Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists