A Study to Evaluate the Effect of ATG-F on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical SCT

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization

Criteria

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.