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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: aGVHD; cGVHD

Treatments: Drug: Rabbit ATG

Study type: Interventional

Funder types: Other

Identifiers

NCT05214066

81370667

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

4-day ATG combined regimen

Experimental group

Description:

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.

Treatment:

Drug: Rabbit ATG