Phase 2
N=56
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Acute Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00623935 ↗Enrolled (actual)
56
Serious AEs
37.5%
Results posted
Jul 2014
Primary outcome: Primary: Percentage of Participants With Relapse Free Survival at 1 Year — 56 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Busulfan (Drug); Total Body Irradiation (Radiation); Stem Cell Transplant (Procedure)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Relapse Free Survival at 1 Year |
56 | — |
| SECONDARY Percentage of Participants Alive at 1 Year |
58 | — |
Summary
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates 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.
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 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 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
Data sourced from ClinicalTrials.gov (NCT00623935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.