Back to resultsBlood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Primary Purpose
Acute Myelogenous Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fludarabine
Busulfan
Total Body Irradiation
Stem Cell Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring AML
Eligibility 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
Sites / Locations
- University of Michigan Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fludarabine plus Busulfan (CR)
Fludarabine plus Busulfan (PR)
Arm Description
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants Alive at 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.
Full Information
NCT ID
NCT00623935
First Posted
February 14, 2008
Last Updated
March 10, 2016
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00623935
Brief Title
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Official Title
Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia
Keywords
AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fludarabine plus Busulfan (CR)
Arm Type
Experimental
Arm Description
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
Arm Title
Fludarabine plus Busulfan (PR)
Arm Type
Experimental
Arm Description
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine (40 mg/m2/day x 4 days)
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
Intervention Type
Radiation
Intervention Name(s)
Total Body Irradiation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Transplant
Intervention Description
Allogeneic stem cell transplant from related or unrelated donor
Primary Outcome Measure Information:
Title
Percentage of Participants With Relapse Free Survival at 1 Year
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of Participants Alive at 1 Year
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Yanik, MD
Organizational Affiliation
University of Michigan Comprehesive Cancer Ctr
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
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