search
Back to results

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

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
ATG-F
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allogeneic Haplo-Stem Cell Transplatation (SCT) focused on measuring mismatched, Stem cell transplatation, Bone marrow transplantation, T cell depletion, engraftment, Patients undergoing allogeneic haplo-SCT

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

with ATG-F

control

Outcomes

Primary Outcome Measures

Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
Day of platelet engraftment >25x10^9/L

Secondary Outcome Measures

AGVHD occurrence
DFS at 100 days
Day of platelet engraftment >50x10^9/L
Time to AGVHD
AGVHD grade
OS
Infections incidence
TRM
TRT

Full Information

First Posted
January 22, 2008
Last Updated
April 19, 2015
Sponsor
Hadassah Medical Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT00616954
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogeneic Haplo-Stem Cell Transplatation (SCT), Graft Versus Host Disease
Keywords
mismatched, Stem cell transplatation, Bone marrow transplantation, T cell depletion, engraftment, Patients undergoing allogeneic haplo-SCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
with ATG-F
Arm Title
2
Arm Type
No Intervention
Arm Description
control
Intervention Type
Drug
Intervention Name(s)
ATG-F
Intervention Description
ATG-f
Primary Outcome Measure Information:
Title
Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
Time Frame
30 days
Title
Day of platelet engraftment >25x10^9/L
Time Frame
30 days
Secondary Outcome Measure Information:
Title
AGVHD occurrence
Time Frame
100 days
Title
DFS at 100 days
Time Frame
100 days
Title
Day of platelet engraftment >50x10^9/L
Time Frame
100 days
Title
Time to AGVHD
Time Frame
100 days
Title
AGVHD grade
Time Frame
100 days
Title
OS
Time Frame
100 days
Title
Infections incidence
Time Frame
100 days
Title
TRM
Time Frame
100 days
Title
TRT
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Not fulfilling any of the inclusion criteria. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Y Shapira, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs