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


Phase 1/Phase 2
18 Years
60 Years
Not Enrolling
Both
Hematologic Malignancies

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Engraftment

Principal Investigator

Wolfgang A Bethge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tuebingen Medical Center

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

E203/2004

NCT ID:

NCT00202917

Start Date:

February 2004

Completion Date:

December 2010

Related Keywords:

  • Hematologic Malignancies
  • haploidentical transplantation
  • immunomagnetic cell sorting
  • allogeneic hematopoietic cell transplantation
  • dose reduced conditioning
  • Neoplasms
  • Hematologic Neoplasms

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