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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

This study has been terminated.
(low recruitment)
Information provided by:
Hadassah Medical Organization Identifier:
First received: January 22, 2008
Last updated: April 19, 2015
Last verified: August 2009
This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation

Condition Intervention Phase
Allogeneic Haplo-Stem Cell Transplatation (SCT)
Graft Versus Host Disease
Drug: ATG-F
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Day of day of neutrophil engraftment (ANC>0.5x10^9/L) [ Time Frame: 30 days ]
  • Day of platelet engraftment >25x10^9/L [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • AGVHD occurrence [ Time Frame: 100 days ]
  • DFS at 100 days [ Time Frame: 100 days ]
  • Day of platelet engraftment >50x10^9/L [ Time Frame: 100 days ]
  • Time to AGVHD [ Time Frame: 100 days ]
  • AGVHD grade [ Time Frame: 100 days ]
  • OS [ Time Frame: 100 days ]
  • Infections incidence [ Time Frame: 100 days ]
  • TRM [ Time Frame: 100 days ]
  • TRT [ Time Frame: 100 days ]

Estimated Enrollment: 50
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
with ATG-F
Drug: ATG-F
No Intervention: 2


Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00616954

Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
  More Information

Responsible Party: Hadassah Medical Organization Identifier: NCT00616954     History of Changes
Other Study ID Numbers: MYS-06-HMO-CTIL
Study First Received: January 22, 2008
Last Updated: April 19, 2015

Keywords provided by Hadassah Medical Organization:
Stem cell transplatation
Bone marrow transplantation
T cell depletion
Patients undergoing allogeneic haplo-SCT

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases processed this record on May 23, 2017