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

Hematologic Malignancies Clinical Trial

Official title:

Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202917
• Other study ID #: E203/2004
• Secondary ID: IRB Project Nr.
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: May 28, 2014
• Start date: February 2004
• Est. completion date: December 2010

Study information

• Verified date: May 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

Drug:
• Fludarabine

• Thiotepa

• Melphalan

• OKT-3

Procedure:
• CD3/CD19 depletion on CliniMACS

Locations

Country	Name	City	State
Germany	University of Dresden Medical Center	Dresden
Germany	Center for Marrow Transplantation	Essen
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	Deutsche Klinik für Diagnostik	Wiesbaden
Germany	University of Wuerzburg Medical Center	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engraftment
Primary	Toxicity
Primary	Mortality and Morbidity
Secondary	Infections
Secondary	GVHD
Secondary	Immune reconstitution
Secondary	Disease response
Secondary	Long term toxicity

External Links

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