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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Fludarabine; Melphalan; Thiotepa

Criteria

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