Clinical trial NCT00616954: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Allogeneic Haplo-Stem Cell Transplatation (SCT)
Graft Versus Host Disease
Keywords: mismatched
Stem cell transplatation
Bone marrow transplantation
T cell depletion
engraftment
Patients undergoing allogeneic haplo-SCT
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
timeFrame: 30 days
measure: Day of platelet engraftment >25x10^9/L
timeFrame: 30 days
Secondary outcomes:
measure: AGVHD occurrence
timeFrame: 100 days
measure: DFS at 100 days
timeFrame: 100 days
measure: Day of platelet engraftment >50x10^9/L
timeFrame: 100 days
measure: Time to AGVHD
timeFrame: 100 days
measure: AGVHD grade
timeFrame: 100 days
measure: OS
timeFrame: 100 days
measure: Infections incidence
timeFrame: 100 days
measure: TRM
timeFrame: 100 days
measure: TRT
timeFrame: 100 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Y Shapira, MD
role: PRINCIPAL_INVESTIGATOR
References: