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

Phase 1

Completed

• Conditions: Hematologic Malignancies

• Registration Number: NCT00202917
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2009-07
• Study Completion: 2010-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mortality and Morbidity
Toxicity
Engraftment

Secondary Outcome Measures

Name	Time	Method
GVHD
Immune reconstitution
Infections
Disease response
Long term toxicity

Trial Locations

Locations (7)

Center for Marrow Transplantation; 🇩🇪 Essen, Germany

University of Wuerzburg Medical Center; 🇩🇪 Wuerzburg, Germany

Deutsche Klinik für Diagnostik; 🇩🇪 Wiesbaden, Germany

University of Dresden Medical Center; 🇩🇪 Dresden, Germany

Medical Center University of Hamburg; 🇩🇪 Hamburg, Germany

Medical Center University of Muenster; 🇩🇪 Muenster, Germany

South West German Cancer Center, University of Tuebingen Medical Center; 🇩🇪 Tuebingen, Germany