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

Prospective Study of Combined 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

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).

Study Overview

• Status: Recruiting
• Conditions: aGVHD; cGVHD
• Intervention / Treatment: Drug: Rabbit ATG

Detailed Description

Transplantation with G-CSF #Granulocyte colony stimulating factor #mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 4-day ATG combined regimen; 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; ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2.; Other Names: Thymoglobuline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with severe cGVHD	Chronic graft versus host disease grading criteria (refer to NIH criteria)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	disease-free survival	1 year
Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)	Cumulative incidence of aGVHD	100 days
OS	overall survival of enrolled patients	1 year
Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria	cumulative incidence of relapse	1 year
NRM	non-relapse mortality	1 year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (ACTUAL): January 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Matched sibling donor; ATG; peripheral blood stem cell transplantation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Thymoglobulin
• Other Study ID Numbers: 81370667

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No