Clinical trial · Interventional
Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders
Phase II Trial of Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Treatment of Adult Patients (>18 Years) With Lymphohematopoietic Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Stem Cell Transplant | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkins | — | UNRESOLVED | — |
| Paroxysmal Nocturnal Hemoglobinuria (PNH) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplant Patients
- interventionNames
- Drug: cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant
Primary outcomes (1)
- measure
- Overall Survival of Transplant Patients
- timeFrame
- up to 6 years
- description
- Calculate the median overall survival of transplant patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic lymphoma or myelodysplastic syndrome * HLA 6/6 or 5/6 antigen matched related or unrelated donor * creatinine = normal or if not, CrCl \> 60 ml/min/1.73ml * total bilirubin \< 2.5, AST \< 2xnl, cardiac function \> 50% * pulmonary function - asymptomatic or if not DLCO \> %50% (corrected for Hgb) * Karnofsky performance status \> 70% * negative pregnancy test (where applicable) * signed informed consent of patient and donor. Exclusion Criteria: * Pregnancy or lactation * unwillingness to comply with protocol treatment or follow-up * uncontrolled infection * HIV or HTLV positivity * active CNS/skin disease
References
Publications (0)
Data not yet available