Clinical trial NCT00202917: Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hematologic Malignancies
Keywords: haploidentical transplantation
immunomagnetic cell sorting
allogeneic hematopoietic cell transplantation
dose reduced conditioning
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Engraftment
measure: Toxicity
measure: Mortality and Morbidity
Secondary outcomes:
measure: Infections
measure: GVHD
measure: Immune reconstitution
measure: Disease response
measure: Long term toxicity
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University of Dresden Medical Center
city: Essen
country: Germany
facility: Center for Marrow Transplantation
city: Hamburg
country: Germany
facility: Medical Center University of Hamburg
city: Muenster
country: Germany
facility: Medical Center University of Muenster
city: Tuebingen
country: Germany
facility: South West German Cancer Center, University of Tuebingen Medical Center
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
city: Wuerzburg
country: Germany
facility: University of Wuerzburg Medical Center
Study officials:
affiliation: University of Tuebingen Medical Center
name: Wolfgang A Bethge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Federmann B, Bornhauser M, Meisner C, Kordelas L, Beelen DW, Stuhler G, Stelljes M, Schwerdtfeger R, Christopeit M, Behre G, Faul C, Vogel W, Schumm M, Handgretinger R, Kanz L, Bethge WA. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study. Haematologica. 2012 Oct;97(10):1523-31. doi: 10.3324/haematol.2011.059378. Epub 2012 Apr 4.