ATG Plus Low-dose PT-Cy for GVHD Prevention

Phase 3TerminatedNCT06108739

Peking University People's Hospital66 enrolled

Overview

During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematologic Malignancy

Interventions

Eligibility

Sex: ALLMin age: 12 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation; 2. Male or female , aged 12-55 years; 3. Haploidentical donor transplantation; 4. ECOG score ≤3; The basic organ function tests met the following standards; 1\) Cardiac ejection index \>55% 2) Creatinine ≤1.5 times the highest normal value (ULN) Exclusion Criteria: 1. Severe brain, heart, kidney or liver dysfunction; 2. Refractory malignant state; 3. Patients with other malignant tumors requiring treatment; 4. Clinically uncontrolled severe active infection; 5. The expected survival time was less than 3 months. 6. A history of severe anaphylaxis. 7. Pregnant or lactating women; 8. Any condition considered by the investigators to be unsuitable for enrollment.

Outcomes

Primary Outcomes

The incidence of acute graft versus host disease.

The incidence of acute graft versus host disease. The severity of acute GVHD was evaluated according to standard international criteria.

Time frame: 100 days post HSCT.

Secondary Outcomes

Engraftment

Myeloid engraftment was defined as the first of three consecutive days with an ANC X0.5≥10\^9/L.

Time frame: 30 days post HSCT.

The incidence of chronic GvHD

The incidence of chronic GvHD.

Time frame: 1 year post HSCT.

The incidence of non-relapse mortality

Time frame: 1 year post HSCT.

The incidence of infection

Time frame: 1 year post HSCT.

The incidence of relapse

Time frame: 1 year post HSCT.

Overall survival

Time frame: 1 year post HSCT.

Disease free survival

Time frame: 1 year post HSCT.

GvHD relapse free survival

Time frame: 1 year post HSCT.

Immune reconstitution

Immune reconstitution was evaluated at 1, 2, 3, 6, 9 and 12 months by analysis of peripheral blood MNCs detecting CD3, CD4, CD19 and immunoglobulin (Ig) A, G and M levels.

Time frame: 1 year post HSCT.

ATG Plus Low-dose PT-Cy for GVHD Prevention

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes