NCT00616954

TerminatedPhase 3

A Study to Evaluate the Effect of ATG-F on Engraftment, Graf...

Hadassah Medical Organization Source

NCT00616954|TerminatedPhase 3

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

Hadassah Medical Organization

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

MYS-06-HMO-CTIL

Study Type

interventional

Estimated enrollment

50

Locations

1 country

Sites

1

Timeline

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2010

Actual (reported)

Study Completion

September 2010

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 50 participants
Study completion date: September 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 22, 2008
Actual (reported)
First Posted
February 15, 2008
Actual (reported)
Study Start
May 2008
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)
Study Completion
September 2010
Actual (reported)

Last Updated: April 21, 2015
Status Verified: August 2009
Last Update Submitted: April 19, 2015

Conditions

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

Keywords

mismatchedStem cell transplatationBone marrow transplantationT cell depletionengraftmentPatients undergoing allogeneic haplo-SCT

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

Study Arms (2)

1

EXPERIMENTAL

with ATG-F

Drug: ATG-F

2

NO INTERVENTION

control

Interventions

ATG-FDrug

ATG-f

1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age3 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

Hadassah Medical Organization
Otherlead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

Michael Y Shapira, MD
Hadassah Medical Organization
PRINCIPAL INVESTIGATOR

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 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2010

Actual (reported)

NCT00366145

Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)

Phase 3Completed

NCT00655343

Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT)

Phase 3Completed

NCT00207792

Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Phase 3Unknown

NCT00298324

Myfortic - Treatment for Extensive cGvHD

Phase 3Terminated

NCT00716690

Multi Donor Mismatched Stem Cell Transplantation (MDT)

Phase 1/2Unknown

NCT02178683

Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression

Phase 3Unknown

Day of platelet engraftment >50x10^9/L

100 days

Time to AGVHD

100 days

AGVHD grade

100 days

+4 more secondary outcomes

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.

Study Completion

September 2010

Actual (reported)

Last Updated

April 21, 2015

Record last verified: 2009-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00616954
Data provider: ClinicalTrials.gov
Source updated: 2015-04-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:44 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations