A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT

NCT03190733 | Unknown Phase 4 DMC

• 1 other identifier: 2016-XYNK-001
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, a randomized, prospective, multicenter, open cohort study was conducted to investigate patients with acute leukemia (14～60-year-old) with different ATG doses (10 mg / kg and 12.5 mg / kg ) in fludarabine, busulfan, cyclophosphamide and antilymphocyte globulin (FBCA) pretreatment protocol of Haploidentical hematopoietic stem cell transplantation (haplo-HSCT). The purpose is to compare the incidences of chronic graft vs host disease (cGVHD) in haplo-HSCT recipients receiving different dose ATG and one year leukemia relapse after transplantation. The main objective was to investigate the optimal dose of ATG for decrease cGVHD and not increase one year relapse leukemia after haplo-HSCT. Its significance is to provide evidence-based medical evidence to reduce the occurrence of cGVHD and to improve the quality of life of patients with haplo-HSCT.

Conditions

Chronic Graft-versus-host-disease; Leukemia Relapse

Keywords

Hematopoietic Stem Cell Transplantation; ATG; chronic GVHD; leukemia relapse

Outcome Measures

Primary Outcomes (1)

• occurrence of chronic GVHD

  chronic GVHD diagnosis based on National Institutes of Health (NIH) criterion

  from the day of stem cell transplantation to one year after stem cell transplantation

Secondary Outcomes (3)

• one year cumulative incidence of leukemia relapse

  from the day of stem cell transplantation to one year after stem cell transplantation

• The cumulative incidence rate of acute GVHD

  from the day of stem cell transplantation to one year after stem cell transplantation

• no relapse mortality one year

  from the day of stem cell transplantation to one year after stem cell transplantation

Study Arms (2)

ATG 10.0mg/kg

EXPERIMENTAL

ATG 10.0mg/kg group refers to treatment with ATG in the total dose of 10.0mg/kg.

Drug: ATG

ATG 12.5mg/kg

ACTIVE COMPARATOR

ATG 12.5mg/kg group refers to treatment with ATG in the total dose of 12.5mg/kg.

Drug: ATG

Interventions

ATG DRUG

ATG will be intravenously infused via a central venous catheter in 4 or 5 days, from day -4 or -3 until day 0. The other conditioning drugs administered before transplantation include fludarabine (Flu), busulfan (Bu),cyclophosphamide (Cy). All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF) for aGVHD prevention.

Also known as: fludarabine

ATG 10.0mg/kg; ATG 12.5mg/kg

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients age between 14 yeas old and 60 years old
• patients with acute myeloid leukemia and acute lymphoblastic leukemia who needed stem cell transplantation without available HLA-identical related or unrelated donors

You may not qualify if:

• Patients with severe infections
• patients with major organ abnormal including renal, liver, lung or heart.
• Patients with any conditions not suitable for the trial (investigators' decision)
• patients age below 14 years old and more than 60 years old.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Nanfang Hospital, Southern Medical University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Second Affiliated Hospital, Sun Yat-Sen University: collaborator

Related Publications (3)

• Lin X, Lu ZG, Song CY, Huang YX, Guo KY, Deng L, Tu SF, He YZ, Xu JH, Long H, Wu BY. Long-term outcome of HLA-haploidentical hematopoietic stem cell transplantation without in vitro T-cell depletion based on an FBCA conditioning regimen for hematologic malignancies. Bone Marrow Transplant. 2015 Aug;50(8):1092-7. doi: 10.1038/bmt.2015.108. Epub 2015 May 11.

  PMID: 25961770 BACKGROUND

• Long H, Lu ZG, Song CY, Huang YX, Xu JH, Xu JX, Deng L, Tu SF, He YZ, Lin X, Guo KY, Wu BY. Long-term outcomes of HLA-haploidentical stem cell transplantation based on an FBCA conditioning regimen compared with those of HLA-identical sibling stem cell transplantation for haematologic malignancies. Bone Marrow Transplant. 2016 Nov;51(11):1470-1475. doi: 10.1038/bmt.2016.170. Epub 2016 Jun 20.

  PMID: 27322852 BACKGROUND

• Chang YJ, Wang Y, Mo XD, Zhang XH, Xu LP, Yan CH, Chen H, Chen YH, Chen Y, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ. Optimal dose of rabbit thymoglobulin in conditioning regimens for unmanipulated, haploidentical, hematopoietic stem cell transplantation: Long-term outcomes of a prospective randomized trial. Cancer. 2017 Aug 1;123(15):2881-2892. doi: 10.1002/cncr.30540. Epub 2017 Mar 16.

  PMID: 28301690 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

fludarabine

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Bingyi Wu, MD

  Zhejiang Hospital of southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianghui xu, Dr

CONTACT

00862062782318; xiaoxu_75@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: August 30, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: June 19, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share