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

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.

Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or autologous hematopoietic cell transplantation.

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