A Phase 2 interventional study of Anti Thymocyte Globulin in Hematopoietic Stem Cell Transplantation, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Chinese PLA General Hospital · Phase 2, Interventional, and Treatment
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To evaluate the safety and efficacy of a population pharmacokinetics (PK)-guided targeted ATG dosing strategy in haploidentical stem cell transplantation and to observe the GVHD-free, relapse-free survival (GRFS) in the cohort receiving this strategy.
Haploidentical hematopoietic stem cell transplantation (haplo-HSCT) has demonstrated remarkable clinical efficacy in treating hematologic malignancies and has become the primary allogeneic transplantation modality in China. However, graft-versus-host disease (GVHD) remains a critical complication that significantly reduces early survival and long-term quality of life (QoL). GVHD not only severely suppresses immune function but also presents challenges in treatment, including complexity, high costs, prolonged duration, and limited efficacy. Therefore, optimizing GVHD prevention strategies offers greater clinical value than expanding treatment options, as it effectively reduces acute and chronic GVHD incidence and improves overall survival (OS) and long-term QoL.
Anti-thymocyte globulin (ATG), a polyclonal immunosuppressant, is widely used in related haplo-HSCT. The conventional high-dose rabbit ATG (Thymoglobulin, 10 mg/kg) effectively promotes engraftment and prevents fatal GVHD but significantly increases the risk of severe viral infections (e.g., CMV, EBV) and may increase relapse rates due to excessive immunosuppression weakening the graft-versus-leukemia (GVL) effect. Dose reduction studies have shown trade-offs: lowering ATG from 10 mg/kg to 6 mg/kg reduced infections but increased severe acute GVHD from 4.5% to 16.1%; a 7.5 mg/kg regimen lowered severe acute GVHD to 7.9% but with significantly higher viral reactivation.
The area under the concentration-time curve (AUC) better reflects ATG exposure than single pharmacokinetic (PK) parameters. The investigators established an ATG-AUC assay and analyzed 106 haplo-HSCT patients receiving uniform 10 mg/kg ATG, revealing substantial inter-individual AUC variability. Some patients had ATG-AUC above or below the optimal exposure window. Modeling of over 1,000 concentration samples (2022) identified the optimal ATG-AUC range as 100-148.5 IU/day/mL. A targeted individualized dosing technique was developed (2023) and validated in a prospective single-arm trial (2024), showing that individualized dosing achieved more patients within or closer to the optimal AUC range compared to fixed dosing. This approach improved post-transplant CD4+ T-cell immune reconstitution, reduced viral reactivation risk without increasing GVHD, and improved long-term survival and QoL.
The next step involves statistical modeling and clinical validation of clinical-biologic parameters (body weight, age, body surface area, lymphocyte count at infusion, graft T-cell count, HLA matching degree) with ATG-AUC from 94 patients to develop a predictive model for individualized ATG dosing. A prospective, single-arm clinical study will be conducted to validate the safety and efficacy of population PK-guided targeted ATG dosing in haplo-HSCT, including the optimal AUC attainment rate (100-148.5 IU/day/mL). Outcomes to be observed include GVHD-free, relapse-free survival (GRFS), viral reactivation rate, acute/chronic GVHD incidence, treatment-related mortality (TRM), disease-free survival (DFS), OS, and immune reconstitution. The goal is to establish the optimal ATG regimen for haplo-HSCT to improve survival and QoL.
Chinese PLA General Hospital is the lead sponsor of 571 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PK-guided ATG dosing
Drug: Anti Thymocyte Globulin
Population pharmacokinetic formula-guided targeted ATG dosing plus classical GVHD prophylaxis regimen
1-year GVHD-free and relapse-free survival rate(1-year-GRFS)
GRFS is defined as the time from randomization to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic immunosuppressive therapy, or death due to disease relapse, whichever occurs first. The cumulative incidence of GRFS will be estimated using the Fine-Gray competing risk model.
Time frame: 1 year after treatment
+180 days CMV virus reactivation rate
+180 days CMV virus reactivation rate refers to the time from randomization to CMV virus reactivation, relapse or death within 180 days post-transplant. The actual incidence rate is calculated as the number of patients with events / total number of cases × 100%.
Time frame: 180 days post-transplant
Acute GVHD incidence
Acute GVHD incidence refers to the time from randomization to acute GVHD onset, relapse or death within 100 days post-transplant. The actual incidence rate is calculated as the number of patients with events / total number of cases × 100%.
Time frame: 100 days post-transplant
disease free survival (DFS)
Disease free survival (DFS) refers to the time from treatment to the first lymphoma recurrence.
Time frame: 1 years after treatment
Cumulative incidence of relapse (CIR)
Cumulative incidence of relapse (CIR) refers to the number of patients with hematologic or MRD relapse from randomization to the last follow-up.
Time frame: 1 years after treatment
Cumulative non-relapse mortality (NRM)
Cumulative non-relapse mortality (NRM) refers to death due to non-relapse causes while in complete remission (CR), measured as the number of patients with NRM from randomization to the last follow-up.
Time frame: 1 years after treatment
PTLD cumulative incidence
Treatment-related safety indicator: cumulative incidence of post-transplant lymphoproliferative disorder (PTLD) from randomization to the last follow-up.
Time frame: [Time Frame: 1 year after treatment]
+180 days EBV virus reactivation rate
The +180-day EBV virus reactivation rate refers to the time from randomization to EBV virus reactivation, relapse, or death within 180 days post-transplant. The actual incidence rate is calculated as the number of patients with events / total number of cases × 100%.
Time frame: 180 days post-transplant
Chronic GVHD cumulative incidence
Treatment-related safety indicator: cumulative incidence of chronic graft-versus-host disease (chronic GVHD) from randomization to the last follow-up.
Time frame: [Time Frame: 1 year after treatment]
Immune reconstitution status
Immune reconstitution status refers to the actual incidence rate calculated as the number of patients with immune reconstitution / total number of cases × 100% from randomization to the last follow-up.
Time frame: 1 years after treatment
Overall Survival (OS)
Overall survival (OS) refers to death from any cause from randomization to the last follow-up. The 1-year OS rate is estimated using the Kaplan-Meier method, calculated as the proportion of patients alive at 1 year after treatment; patients lost to follow-up are censored at the date of last contact.
Time frame: 1 year after treatment
Plan to share: No
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Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
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