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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616954
Recruitment Status : Terminated (low recruitment)
First Posted : February 15, 2008
Last Update Posted : April 21, 2015
Information provided by:
Hadassah Medical Organization

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
with ATG-F
Drug: ATG-F

No Intervention: 2

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

Secondary Outcome Measures :
  1. AGVHD occurrence [ Time Frame: 100 days ]
  2. DFS at 100 days [ Time Frame: 100 days ]
  3. Day of platelet engraftment >50x10^9/L [ Time Frame: 100 days ]
  4. Time to AGVHD [ Time Frame: 100 days ]
  5. AGVHD grade [ Time Frame: 100 days ]
  6. OS [ Time Frame: 100 days ]
  7. Infections incidence [ Time Frame: 100 days ]
  8. TRM [ Time Frame: 100 days ]
  9. TRT [ Time Frame: 100 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616954

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

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Responsible Party: Hadassah Medical Organization Identifier: NCT00616954    
Other Study ID Numbers: MYS-06-HMO-CTIL
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: August 2009
Keywords provided by Hadassah Medical Organization:
Stem cell transplatation
Bone marrow transplantation
T cell depletion
Patients undergoing allogeneic haplo-SCT
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases