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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)
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00616954
First received: January 22, 2008
Last updated: March 1, 2011
Last verified: August 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • Day of platelet engraftment >25x10^9/L [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated 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
ATG-f
No Intervention: 2
control

  Eligibility

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616954

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

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00616954     History of Changes
Other Study ID Numbers: MYS-06-HMO-CTIL
Study First Received: January 22, 2008
Last Updated: March 1, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2014