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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00202917

Enrollment

Registered

2005-09-20

Start date

2004-02-29

Completion date

2010-12-31

Last updated

2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies

Keywords

haploidentical transplantation, immunomagnetic cell sorting, allogeneic hematopoietic cell transplantation, dose reduced conditioning

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.

Interventions

DRUGFludarabine

DRUGThiotepa

DRUGMelphalan

DRUGOKT-3

PROCEDURECD3/CD19 depletion on CliniMACS

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Engraftment	—
Toxicity	—
Mortality and Morbidity	—

Secondary

Measure	Time frame
Disease response	—
Infections	—
Long term toxicity	—
GVHD	—
Immune reconstitution	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026