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An Investigator Initiated, Prospective, Randomized, Controlled Study in Order to Evaluate the Effect of Anti-thymocyte Globulin (Fresenius ATG) on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical Allogeneic Hematopoietic Stem-cell Transplantation


Phase 3
3 Years
70 Years
Not Enrolling
Both
Allogeneic Haplo-Stem Cell Transplatation (SCT), Graft Versus Host Disease

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Trial Information

An Investigator Initiated, Prospective, Randomized, Controlled Study in Order to Evaluate the Effect of Anti-thymocyte Globulin (Fresenius ATG) on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical Allogeneic Hematopoietic Stem-cell Transplantation


Inclusion Criteria:



1. Patient age 3-70 years old with a disease necessitating allogeneic SCT.

2. Patients must have a mismatched donor willing and capable of donating peripheral
blood stem cells and/or bone marrow progenitor cells using conventional techniques,
and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).

3. Each patient / patient's guardian must sign written informed consent.

4. Patients must have an ECOG PS ≤ 2; Creatinine <2.0 mg/dl; Ejection fraction >40%;
DLCO >50% of predicted; Serum bilirubin <3 gm/dl; elevated GPT or GOT >3 x normal
values.

Exclusion Criteria:

1. Not fulfilling any of the inclusion criteria.

2. Active life-threatening infection.

3. Overt untreated infection.

4. Known hypersensitivity to ATG.

5. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active
hepatitis.

6. Pregnant or lactating women.

7. Donor contraindication (HIV seropositive confirmed by Western Blot Hepatitis B
antigenemia; positive HCV antibodies with positive HCV PCR; evidence of bone marrow
disease; unable to donate bone marrow or peripheral blood due to concurrent medical
condition).

8. Inability to comply with study requirements.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Day of day of neutrophil engraftment (ANC>0.5x10^9/L)

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Michael Y Shapira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

MYS-06-HMO-CTIL

NCT ID:

NCT00616954

Start Date:

May 2008

Completion Date:

September 2010

Related Keywords:

  • Allogeneic Haplo-Stem Cell Transplatation (SCT)
  • Graft Versus Host Disease
  • mismatched
  • Stem cell transplatation
  • Bone marrow transplantation
  • T cell depletion
  • engraftment
  • Patients undergoing allogeneic haplo-SCT
  • Graft vs Host Disease
  • Leukemia

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