ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

NCT ID: NCT04203108

Last Updated: 2019-12-18

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

PHASE4

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-12-31

Brief Summary

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The protocols including ciclosporin A (CsA)+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.

Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplantation

Keywords

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Hematopoietic Stem Cell Transplantation antithymocyte globulin graft-versus-host disease

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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ATG group

ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.

Group Type EXPERIMENTAL

ATG

Intervention Type DRUG

In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.

CsA

Intervention Type DRUG

In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.

MTX

Intervention Type DRUG

In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).

MMF

Intervention Type DRUG

In both groups, MMF will be administrated at a dose of 1.0g/d.

non-ATG group

Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.

Group Type ACTIVE_COMPARATOR

CsA

Intervention Type DRUG

In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.

MTX

Intervention Type DRUG

In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).

MMF

Intervention Type DRUG

In both groups, MMF will be administrated at a dose of 1.0g/d.

Interventions

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ATG

In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.

Intervention Type DRUG

CsA

In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.

Intervention Type DRUG

MTX

In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).

Intervention Type DRUG

MMF

In both groups, MMF will be administrated at a dose of 1.0g/d.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. A patient age of 18-65 years
2. MSD transplant recipient
3. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria

1. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
2. Patients with any conditions not suitable for the trial (investigators' decision)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifa Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qifa Liu

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ren Lin, MD

Role: CONTACT

Phone: +86-020-62787883

Email: [email protected]

Facility Contacts

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Ren Lin

Role: primary

Other Identifiers

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ATG in HLA-matched HSCT-2019

Identifier Type: -

Identifier Source: org_study_id