NCT03631563

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

5.8 years

First QC Date

August 13, 2018

Last Update Submit

August 13, 2018

Conditions

GVHD in the Setting of Haplo-HSCT

Outcome Measures

Primary Outcomes (1)

  • incidence of GVHD

    1 year

Secondary Outcomes (2)

  • leukemia-free survival

    1 year

  • treatment-related mortality

    1 year

Study Arms (2)

Arm 1

EXPERIMENTAL

ATG-F treated

Drug: Immunosuppressive Agent

Arm 2

ACTIVE COMPARATOR

ATG treated

Drug: Immunosuppressive Agent

Interventions

Immunosuppressive AgentDRUG

ATG-Fresenius versus ATG

Arm 1Arm 2

Eligibility Criteria

AgeUp to 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of ATG or ATG-F.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Interventions

Immunosuppressive Agents

Intervention Hierarchy (Ancestors)

Immunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

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

CONTACT

86-13950210357yang.hopeting@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.M.D.Ph.D

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

March 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

CN(1)