Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
2 other identifiers
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2007
Longer than P75 for phase_2
1 active site
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
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedResults Posted
Study results publicly available
July 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedApril 8, 2016
March 1, 2016
6.3 years
February 14, 2008
June 17, 2014
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Relapse Free Survival at 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 Outcomes (1)
Percentage of Participants Alive at 1 Year
1 year
Study Arms (2)
Fludarabine plus Busulfan (CR)
EXPERIMENTALPatients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
Fludarabine plus Busulfan (PR)
EXPERIMENTALPatients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
Interventions
Fludarabine (40 mg/m2/day x 4 days)
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
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.
Allogeneic stem cell transplant from related or unrelated donor
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gregory Yanik, M.D.
- Organization
- University of Michigan Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Yanik, MD
University of Michigan Comprehesive Cancer Ctr
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 26, 2008
Study Start
March 1, 2007
Primary Completion
June 1, 2013
Study Completion
November 1, 2015
Last Updated
April 8, 2016
Results First Posted
July 17, 2014
Record last verified: 2016-03