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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616954

Enrollment

Registered

2008-02-15

Start date

2008-05-31

Completion date

2010-09-30

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Interventions

DRUGATG-F

ATG-f

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Day of day of neutrophil engraftment (ANC>0.5x10^9/L)	30 days
Day of platelet engraftment >25x10^9/L	30 days

Secondary

Measure	Time frame
Day of platelet engraftment >50x10^9/L	100 days
Time to AGVHD	100 days
AGVHD grade	100 days
AGVHD occurrence	100 days
Infections incidence	100 days
TRM	100 days
TRT	100 days
OS	100 days
DFS at 100 days	100 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026