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

Graft Versus Host Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00616954
• Other study ID #: MYS-06-HMO-CTIL
• Status: Terminated
• Phase: Phase 3
• First received: January 22, 2008
• Last updated: April 19, 2015
• Start date: May 2008
• Est. completion date: September 2010

Study information

• Verified date: August 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allogeneic Haplo-Stem Cell Transplatation (SCT)
• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• ATG-F
ATG-f

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day of day of neutrophil engraftment (ANC>0.5x10^9/L)		30 days	Yes
Primary	Day of platelet engraftment >25x10^9/L		30 days	Yes
Secondary	AGVHD occurrence		100 days	Yes
Secondary	DFS at 100 days		100 days	Yes
Secondary	Day of platelet engraftment >50x10^9/L		100 days	Yes
Secondary	Time to AGVHD		100 days	Yes
Secondary	AGVHD grade		100 days	Yes
Secondary	OS		100 days	Yes
Secondary	Infections incidence		100 days	Yes
Secondary	TRM		100 days	Yes
Secondary	TRT		100 days	Yes