Clinical trial · Interventional
Myeloablative Allogeneic Stem Cell Transplantation Using a Naive T-Cell Depleted Peripheral Blood Stem Cell Graft
NCT00814983CI-TRIAL-00012722terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IND approval for naive T-cell depletion not obtained
Summary
Brief summary (as posted)
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 secondary objectives will be to measure the pace of immune recovery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| ANLL | Acute Myeloid Leukemia | ALIAS | 0.90 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| NHL | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isolex device from Baxter | Device | — | UNRESOLVED |
| Naive T-cell Depleted Stem Cell Transplant | Procedure | — | UNRESOLVED |
| Stem Cell Transplant No Manipulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Naive T-cell Depleted Stem Cell Transplant
- description
- Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
- interventionNames
- Procedure: Naive T-cell Depleted Stem Cell Transplant
- Device: Isolex device from Baxter
- type
- ACTIVE_COMPARATOR
- label
- Stem Cell Transplant No Manipulation
- description
- Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
- interventionNames
- Procedure: Stem Cell Transplant No Manipulation
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Patients with \> 5% blasts in bone marrow or peripheral circulation. * Patients with rapidly progressive ANLL or ALL.
References
Publications (0)
Data not yet available
No reference posted for this study.