Study Stopped
low recruitment
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
1 other identifier
interventional
50
1 country
1
Brief Summary
This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 21, 2015
August 1, 2009
2.1 years
January 22, 2008
April 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
30 days
Day of platelet engraftment >25x10^9/L
30 days
Secondary Outcomes (9)
AGVHD occurrence
100 days
DFS at 100 days
100 days
Day of platelet engraftment >50x10^9/L
100 days
Time to AGVHD
100 days
AGVHD grade
100 days
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALwith ATG-F
2
NO INTERVENTIONcontrol
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Y Shapira, MD
Hadassah Medical Organization
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 22, 2008
First Posted
February 15, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2010
Study Completion
September 1, 2010
Last Updated
April 21, 2015
Record last verified: 2009-08