Overview

This trial is active, not recruiting.

Condition acute myelogenous leukemia
Treatments fludarabine, busulfan, total body irradiation, stem cell transplant
Phase phase 2
Sponsor Gregory Yanik, MD
Start date March 2007
End date June 2013
Trial size 56 participants
Trial identifier NCT00623935, HUM00006772, UMCC 2006.065

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
fludarabine
Fludarabine (40 mg/m2/day x 4 days)
busulfan
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
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.
stem cell transplant
Allogeneic stem cell transplant from related or unrelated donor
(Experimental)
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
fludarabine
Fludarabine (40 mg/m2/day x 4 days)
busulfan
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
stem cell transplant
Allogeneic stem cell transplant from related or unrelated donor

Primary Outcomes

Measure
Percentage of Participants With Relapse Free Survival at 1 Year
time frame: 1 year

Secondary Outcomes

Measure
Percentage of Participants Alive at 1 Year
time frame: 1 year

Eligibility Criteria

Male or female participants from 55 years up to 70 years old.

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

Additional Information

Official title Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Principal investigator Gregory Yanik, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.