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

Phase 3

Terminated

• Conditions: Allogeneic Haplo-Stem Cell Transplatation (SCT); Graft Versus Host Disease
• Interventions: Drug: ATG-F

• Registration Number: NCT00616954
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-15
• Study Start: 2008-05
• Status Verified: 2009-08
• Primary Completion: 2010-06
• Study Completion: 2010-09
• Last Update Submitted: 2015-04-19
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ATG-F	with ATG-F

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel