Status:
COMPLETED
Purine Analog-Based Conditioning in Patients With Severe Aplastic Anemia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Aplastic Anemia
Eligibility:
All Genders
Up to 70 years
Phase:
NA
Brief Summary
Primary Objectives: 1. To determine the feasibility and toxicity of employing purine-analog based conditioning for allogeneic donor stem cell transplantation in patients with severe aplastic anemia (...
Detailed Description
Before treatment starts, patients will have their bone marrow checked and will have lung, heart, and kidney tests. Patients in this study will receive the drugs fludarabine, cyclophosphamide, and ant...
Eligibility Criteria
Inclusion
- Patients up to 70 years of age with a diagnosis of severe AA (Camitta et al., 1979) and a matched unrelated donor who are unresponsive to IS or who have relapsed after an initial response to IS. Patients with a diagnosis of SAA and an human leukocyte antigen (HLA) - compatible sibling donor are eligible only if they are 40 years of age or older (up to age 70) and regardless whether they have received IS or not. Patients with primary or secondary graft failure following autologous or allogeneic stem cell transplant are eligible.
- Patients must have a serum bilirubin of 2 mg/dl or less, serum creatinine \< 2.0 mg/dl, no symptomatic cardiac or pulmonary disease and a PS of no more than 2. Life expectancy not severely limited by concomitant illness (\> 12 weeks). Left ventricular ejection fraction \> 40%, no uncontrolled arrhythmia or symptomatic cardiac disease. Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) \> 40%. No symptomatic pulmonary disease. Negative pregnancy test.
- Patients must have an HLA-compatible related or unrelated donor willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells. In the event of transplants from matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 and DQB1 ("10 of 10 match") is preferred. However, a one-antigen mismatch ("micromismatch") is also considered acceptable matching ("9 of 10 match").
- Patients must sign informed consent. In the event of a pediatric patient (i.e., a minor), consent will be provided by their guardian/parent.
- Lack of clonal cytogenetic abnormalities associated with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or other hematologic malignancies.
Exclusion
- Life expectancy of less than 8 weeks. Inability to provide informed consent.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00427336
Start Date
December 1 2000
End Date
August 1 2009
Last Update
October 27 2011
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030