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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT00202917

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: Fludarabine Drug: Thiotepa Drug: Melphalan Drug: OKT-3 Procedure: CD3/CD19 depletion on CliniMACS	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Dec 1, 2010

Outcome Measures

Primary Outcome Measures

Engraftment []
Toxicity []
Mortality and Morbidity []

Secondary Outcome Measures

Infections []
GVHD []
Immune reconstitution []
Disease response []
Long term toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University of Dresden Medical Center	Dresden	Germany	D-01307
2	Center for Marrow Transplantation	Essen	Germany	45122
3	Medical Center University of Hamburg	Hamburg	Germany	20246
4	Medical Center University of Muenster	Muenster	Germany	48129
5	South West German Cancer Center, University of Tuebingen Medical Center	Tuebingen	Germany	72076
6	Deutsche Klinik für Diagnostik	Wiesbaden	Germany	65191
7	University of Wuerzburg Medical Center	Wuerzburg	Germany	D-97070