Efficacy and Safety Study of 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

NCT05214066 | Unknown Phase 2 DMC

• 1 other identifier: 81370667
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of combined ATG #antithymocyte globulin # regimen (5mg/kg divided from day -5 to day -2) for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).

Conditions

aGVHD; cGVHD

Keywords

ATG; Matched sibling donor; peripheral blood stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Number of participants with severe cGVHD

  Chronic graft versus host disease grading criteria (refer to NIH criteria)

  1 year

Secondary Outcomes (5)

• Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)

  100 days

• OS

  1 year

• Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria

  1 year

• DFS

  1 year

• NRM

  1 year

Study Arms (1)

4-day ATG combined regimen

EXPERIMENTAL

ATG combined regimen for prophylaxis of GVHD, includes ATG, MMF (Mycophenolate mofetil), CsA (cyclosporin A) and MTX (methotrexate). All recipients in this arm received ATG, CsA, mycophenolate mofetil, and short-term methotrexate for GVHD prophylaxis. ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2. CsA (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered. From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30. After graft infusion, MTX was given for all patients at 15 mg/m2 on day +1 and 10 mg/m2 on days +3, +6 and +11.

Drug: Rabbit ATG

Interventions

Rabbit ATG DRUG

ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2.

Also known as: Thymoglobuline

4-day ATG combined regimen

Eligibility Criteria

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

You may qualify if:

• Patients were aged from 14 to 65 years;
• Patients were diagnosed of acute leukemia or MDS;
• There were indications of MSD-PBSCT for these patients;
• Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases.

You may not qualify if:

• Patients with any uncontrolled infections or with severe pulmonary,renal, hepatic or cardiac diseases;
• AML patients with t (15;17).

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

thymoglobulin; Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Daihong Liu, Doctor

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Daihong Liu, Doctor

CONTACT

+8613681171597; daihongrm@163.com

Liping Dou, Doctor

CONTACT

+8613681207138; lipingruirui@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 28, 2022
• Study Start: February 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-01

Locations

CN (1)