Clinical trial · Interventional
Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases
NCT01919866CI-TRIAL-00015799unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemias | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Aplastic Anemia | — | UNRESOLVED | — |
| Childhood Solid Tumor | Childhood Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transplantation of CD3/CD19 depleted stem cells | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplantation of CD3/CD19 depleted stem cells
- description
- Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW
- interventionNames
- Other: Transplantation of CD3/CD19 depleted stem cells
Primary outcomes (1)
- measure
- Engraftment rate and transplant related mortality
- timeFrame
- 365 days
- description
- engraftment rate will be evaluated by leukocyte counts in peripheral blood . Definition of engraftment: \>500 neutrophiles/µl blood. Transplant related mortality will be evaluated at day 100 and day 365 post transplant
Secondary outcomes (1)
- measure
- Graft versus Host disease and speed of immune reconstitution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease) * AML in complete remission of refractory * MDS RAEB-t/secondary AML * ALL * CML * Non-Hodgkin Lymphoma / Hodgkin Lymphoma * non malignant diseases (aplastic anemia, thalassemia, SCID) * relapsed Neuroblastoma * relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET * soft tissue sarcoma with primary bone metastases or bone marrow * in whom no matched donor was available, Exclusion Criteria: * \< 6 months after previous HSCT * active cerebral seizure conditions * massive progression of leukemias or solid tumours before planned trp. * left ventricular ejection fraction \<25% * creatinine clearance \<40ml/min before conditioning * respiratory insufficiency with oxygen demand or DLCO \<30% * Bilirubin \>4mg/dl, GOT/GPT \>400 * severe infection (HIV, Aspergillosis) * pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.