Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies

University Hospital Tuebingen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hematologic Malignancies

Treatments: Procedure: CD3/CD19 depletion on CliniMACS; Drug: OKT-3; Drug: Fludarabine; Drug: Thiotepa; Drug: Melphalan

Study type: Interventional

Funder types: Other

Identifiers

NCT00202917

IRB Project Nr. 21/2004

E203/2004

HSZ-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)