Low Dose ATG Plus Low Dose PTCy as GVHD Prophylaxis in Haplo-HSCT

NCT03395860 | Unknown Phase 2 DMC

• 2 other identifiers: SHSYXY-ATG/PTCyNSFC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Low dose Rabbit Antithymocyte Globulin plus Low-dose post-transplantation cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical hematopoietic stem cell transplantation for patients with hematologic malignancies

Conditions

Graft-versus-host-disease; Prophylaxis

Keywords

GVHD; ATG; PTCy; halo-HSCT

Outcome Measures

Primary Outcomes (1)

• The cumulative incidences of acute GVHD

  The cumulative incidences of aGvHD was defined as the number and the ratio of the participants with aGVHD

  100 days after transplantation

Secondary Outcomes (6)

• Leukocyte engraftment

  1 MONTH

• Platelet engraftment

  1 MONTH

• Donor chimerism

  2 YEARS

• Relapse incidence (RI)

  2 YEARS

• chronic GVHD

  2 year

Study Arms (2)

group A

EXPERIMENTAL

low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-3-d-2 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3

Drug: ATG

group B

EXPERIMENTAL

low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-2-d-1 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3

Drug: ATG

Interventions

ATG DRUG

group A:low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-3-d-2 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3 group B:low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-2-d-1 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3

Also known as: PTCY

group A; group B

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with hematologic malignancies (AML, ALL, high-risk MDS, lymphoma, CML) were enrolled in this study. Diagnosis was according to the criteria of 2008 World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissues.
• Family members selected as donors were typed at the HLA-A, -B, -DQB1, -C and -DRB1 locus at high-resolution level. Haplo was defined as recipient-donor number of HLA mismatches \> 2.(20)
• to 70 years old.
• Performance status scores no more than 3 (ECOG criteria).
• Adequate organ function as defined by the following criteria: alanine transaminase （ALT）, aspartate transaminase（AST） and total serum bilirubin \<2×ULN (upper limit of normal). Serum creatinine and blood urea nitrogen (BUN) \<1.25×ULN.
• Adequate cardiac function without acute myocardial infarction, arrhythmia or atrioventricular block, heart failure, active rheumatic heart disease and cardiac dilatation(the patients has been improved after treatment of the disease and are not expected to affect transplant can include in the study).
• Absence of any other contraindications of stem cell transplantation. Willingness and ability to perform HSCT.
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• Presence of any condition inappropriate for HSCT.
• Life expectancy \< 3 months because of other severe diseases.
• Presence of any fatal disease, including respiratory failure, heart failure, liver or kidney function failure.
• Uncontrolled infection.
• Pregnancy or breastfeeding.
• Has enrolled in another clinical trials.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai First People's HOSPITAL

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• xinpeng wang, doctor

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

yang, master

CONTACT

18001890183; yangjuan74@hotmail.com

xianming song, doctor

CONTACT

13501672508; shongxm@sjtu.edu.cn

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: Head of Hematology

Model Details: drug: rATG drug: PTCy

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: January 10, 2018
• Study Start: May 30, 2017
• Primary Completion: May 20, 2020
• Study Completion: December 20, 2021
• Last Updated: April 16, 2019

Record last verified: 2018-05

Locations

CN (1)