Clinical trial · Interventional
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies
NCT00202917CI-TRIAL-00014727completedPhase 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)
The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD3/CD19 depletion on CliniMACS | Procedure | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| OKT-3 | Drug | — | UNRESOLVED |
| Thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Engraftment
- measure
- Toxicity
- measure
- Mortality and Morbidity
Secondary outcomes (5)
- measure
- Infections
- measure
- GVHD
- measure
- Immune reconstitution
- measure
- Disease response
- measure
- Long term toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Age \<60, \>18 years * Karnofsky \>60% * High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with: * ALL * AML * PNH * MDS (RAEB-t/secondary AML) * NHL * ALL * HD * CML * MM * No HLA-identical MRD or URD if not preceding allo-HCT * Use haploidentical donor with KIR-Mismatch if choice Exclusion Criteria: * \< 3 months after preceding HCT * Active cerebral seizures * \> 30% blasts in BM if ALL/AML/CML-BC * Completely chemo-refractory * Preceding myocardial infarction * Ejection fraction \<30 % echocardiography * Creatinine clearance \<50 ml/min * Respiratory insufficiency on supplemental O2 or DLCO \< 30% * Allergy against murine antibodies * HIV infection * Pregnancy * Unable for informed consent
References
Publications (1)
- DERIVEDFedermann B, Bornhauser M, Meisner C, Kordelas L, Beelen DW, Stuhler G, Stelljes M, Schwerdtfeger R, Christopeit M, Behre G, Faul C, Vogel W, Schumm M, Handgretinger R, Kanz L, Bethge WA. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study. Haematologica. 2012 Oct;97(10):1523-31. doi: 10.3324/haematol.2011.059378. Epub 2012 Apr 4. PMID 22491731