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

Hadassah Medical Center

Status and phase

Terminated

Phase 3

Conditions

Graft Versus Host Disease

Allogeneic Haplo-Stem Cell Transplatation (SCT)

Treatments

Drug: ATG-F

Study type

Interventional

Funder types

Other

Identifiers

MYS-06-HMO-CTIL

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

3 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient age 3-70 years old with a disease necessitating allogeneic SCT.
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).
Each patient / patient's guardian must sign written informed consent.
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

Not fulfilling any of the inclusion criteria.
Active life-threatening infection.
Overt untreated infection.
Known hypersensitivity to ATG.
HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
Pregnant or lactating women.
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).
Inability to comply with study requirements.