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

Phase 2CompletedNCT00202917

University Hospital Tuebingen61 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematologic Malignancies

Interventions

FludarabineDRUG

ThiotepaDRUG

MelphalanDRUG

OKT-3DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Münster, Germany

Outcomes

Primary Outcomes

Engraftment

Toxicity

Mortality and Morbidity

Secondary Outcomes

Infections

GVHD

Immune reconstitution

Disease response

Long term toxicity

Data from ClinicalTrials.gov

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