ATG-F VS ATG for the Prevention of GVHD

NCT ID: NCT03631563

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-01

Study Completion Date

2020-12-01

Brief Summary

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Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.

Detailed Description

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Conditions

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GVHD in the Setting of Haplo-HSCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

ATG-F treated

Group Type EXPERIMENTAL

Immunosuppressive Agent

Intervention Type DRUG

ATG-Fresenius versus ATG

Arm 2

ATG treated

Group Type ACTIVE_COMPARATOR

Immunosuppressive Agent

Intervention Type DRUG

ATG-Fresenius versus ATG

Interventions

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Immunosuppressive Agent

ATG-Fresenius versus ATG

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* Aged \<65 years
* Patients undergoing Haplo-identical hematopoietic stem cell transplantation.
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of ATG or ATG-F.
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ting YANG

Prof.M.D.Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Yang, Prof.M.D.Ph.D

Role: CONTACT

86-13950210357

Facility Contacts

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Ting Yang, Prof.M.D.Ph.D

Role: primary

86-13950210357

Other Identifiers

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ATG-F VS ATG-01

Identifier Type: -

Identifier Source: org_study_id

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