Status:
TERMINATED
Myeloablative Allogeneic Stem Cell Transplantation Using a Naive T-Cell Depleted Peripheral Blood Stem Cell Graft
Lead Sponsor:
Duke University
Conditions:
ALL
ANLL
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objectives will be to measure the safety and efficacy of allogeneic stem cell transplantation using a peripheral blood stem cell graft that has been depleted of CD45RA+ Naive T-cells. The...
Detailed Description
A cohort of patients (Cohort 1) will be enrolled to receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation. With the exception of volume and/or plasma d...
Eligibility Criteria
Inclusion
- Age 18 to 65 years.
- 8/8 or 7/8 HLA-identical matched sibling OR Allele level 8/8 (HLA-A, B, C, DRbeta1) matched unrelated donor.
- Patients with high risk ALL in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22) or t(1;19) or patients presenting with extreme hyperleukocytosis (WBC\>500,000/ml) or partial remission after initial induction therapy.
- Adult patients with acute non-lymphocytic Leukemia (ANLL) in first complete remission with high-risk cytogenetics (monosomy chromosome 5 or 7, del(5q), abn(3q26), complex karyotypic abnormalities) or failure to achieve complete remission after standard induction therapy.
- All patients with ALL or ANLL in second or subsequent remission or partial remission (\<5% blasts in bone marrow as measured by flow cytometry).
- All patients with CML in chronic (failed interferon and/or Gleevec) or accelerated phase.
- Patients with myelodysplastic syndrome with International Prognostic Scoring System (IPSS) risk category of INT-1 or greater.
- Myelofibrosis with myeloid metaplasia
- Patients with severe aplastic anemia must have failed immunosuppressive therapy such as cyclosporine plus anti-thymocyte globulin.
- Patients with a history of CNS disease must have been treated and have no active CNS disease at the time of protocol treatment.
- ECOG performance status \<2
- Patients must have adequate function of other organ systems as measured by:
- Creatinine clearance (by Cockcroft Gault equation \[Appendix IV\]) \> 30ml/min. Hepatic transaminases (ALT/AST) \< 4 x normal, bilirubin \< 2.0 mg/dl.
- Pulmonary function tests demonstrating FVC and FEV1 of \>50% of predicted for age and DLCO \> 50% of predicted.
- Ejection fraction of \>45% by echocardiogram, radionuclide scan or cardiac MRI.
- Patients must be HIV negative.
- Patients must not be pregnant.
Exclusion
- Patients with \> 5% blasts in bone marrow or peripheral circulation.
- Patients with rapidly progressive ANLL or ALL.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00814983
Start Date
July 1 2007
End Date
September 1 2013
Last Update
November 25 2013
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