LeukemiaPhase 2/3NCT06895538
Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy
A Phase 2/3 study testing Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) in people with Leukemia and MDS, run by Peking University First Hospital at 1 site in China.
Trial summary
Allogeneic hematopoietic stem cell transplantation is the only curative treatment for malignant hematologic diseases. However, immune rejection is a major limitation in its application. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2025to 28 Feb 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1）Age ≧18 years, gender is not limited;
- 2）Histologically or cytologically confirmed diagnosis of malignant hematologic diseases;
- 3) First time undergoing allogeneic hematopoietic stem cell transplantation;
- 4) ECOG score 0-2;
- 5) Hepatic and renal function, cardiopulmonary function meet the following requirements.
- Serum creatinine ≤ 1.5 ULN; ②Left ventricular ejection fraction ≥ 45%;
Show all 10Show fewer
- Blood oxygen saturation >91%;
- Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 3 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltrates or bile duct obstruction), in the judgment of the investigator, the values may be adjusted to ≤ 5 × ULN;
- 6) Expected survival is longer than 12 weeks;
- 7) The subjects will voluntarily and strictly comply with the requirements of the study protocol and will sign a written informed consent form.
Who cannot join
- 1) Prior treatment with ATG, ALG, or ATLG drugs within the past six months;
- 2) Allergic to any component of ATLG or ATG;
- 3) Bacterial, viral, parasitic, or mycobacterial infections not adequately controlled by treatment, i.e., inability to undergo hematopoietic stem cell transplantation due to severe infection.
- 4) Women who are pregnant or breastfeeding, or participants of childbearing potential who are unwilling or unable to use effective methods of contraception; 5) Participants enrolled in another clinical trial (of any investigational drug or device) within 30 days prior to the subject's baseline visit. (Subjects enrolled in observational studies are eligible to participate).
- 6) Any other circumstance that, in the judgment of the investigator, may interfere with the conduct of the clinical trial and the determination of the results of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Jialin Zhu, MD, +86-13671375500, julie920219@163.com
About this study
Official title: An Exploratory, Non-Randomized, Controlled Study of the Effect of Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) Versus Anti-Thymocyte Immunoglobulin (ATG) on Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematologic Diseases
Allogeneic hematopoietic stem cell transplantation is the only curative treatment for malignant hematologic diseases. However, immune rejection is a major limitation in its application. In the "Beijing Protocol", the use of granulocyte colony-stimulating factor (G-CSF) in combination with anti-thymocyte globulin (ATG) can achieve "everyone has a donor". The use of ATG, however, can interfere with the recovery of immune function after transplantation, increasing the risk of life-threatening complications such as viral infections or graft-versus-host disease. Rabbit anti-human T-lymphocyte immunoglobulin (ATLG) is currently approved for the prevention of organ transplant rejection, which is produced differently from ATG. Previous studies have shown that transplant preconditioning with ATLG is effective in preventing graft-versus-host disease and even reduces the incidence of cytomegalovirus, etc. after transplantation. In this study, we will prospectively apply containing ATLG in a cohort of allogeneic hematopoietic stem cell transplantation for malignant hematologic diseases and dynamically observe the state of immune reconstitution of patients after transplantation. We will also compare it with a matched cohort of conventional combined ATGs during the same period to explore the impact of ATLG on immune reconstitution after transplantation.
Read the detailed description
Hematological malignancies (referred to as malignant hematological diseases) are a class of major diseases that pose a significant threat to human health. Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains an effective, if not the sole, treatment option for hematological tumors. Due to the potential for immune rejection, HSCT has historically been constrained to HLA-compatible siblings or non-consanguineous donors, significantly restricting its clinical application. In consideration of the findings from preceding studies, Huang's research team employed the immunomodulatory property of G-CSF in conjunction with anti-thymocyte globulin (ATG) to undertake the non-in vitro eradication of T lymphocytes for haplotype-conjugate HSCT. A series of studies were published in 2004 and 2013 that utilized G-CSF in combination with ATG to facilitate HSCT implantation. These studies demonstrated a correlation between the degree of HLA non-conformity and the degree of graft-versus-host disease (GVHD). This suggests that G-CSF combined with ATG successfully crosses the human leukocyte antigen (HLA) barrier, and that haploidentical transplantation has gradually become the most clinically utilized type of transplantation. However, clinical studies and real-world results have demonstrated that the application of ATG has the potential to enhance the risk of post-transplant cytomegalovirus (CMV), EBV activation or even infection, and post-transplant lymphoproliferative disease (PTLD).
A study published in 2023 utilized a retrospective analysis of clinical outcomes to examine patients who received two distinct sources of allogeneic T-cell-depleted (ATG) transplants. The findings indicated that patients who received ATLG during transplantation exhibited a reduced incidence of cytomegalovirus (CMV) infection. In a seminal study, Wang Shunqing and colleagues investigated the role, toxicities, and effects of ATG/ATLG on transplantation complications in non-myeloablative hematopoietic stem cell transplantation. Their findings demonstrated that the administration of ATG/ATLG during non-myeloablative hematopoietic stem cell transplantation was both safe and effective. Notably, it was observed to promote the implantation of hematopoietic stem cells, reduce the incidence of acute graft-versus-host disease (aGVHD), and decrease its severity. Huang Wenrong and colleagues investigated the effectiveness and safety of ATLG/ATLG in unrelated donor allogeneic peripheral hematopoietic stem cell transplantation. The study demonstrated that ATLG significantly reduced the incidence of cGVHD, decreased the occurrence of adverse events, and effectively controlled the occurrence of aGVHD. Lu Daopei et al. investigated the effectiveness and safety of ATG/ATLG in haploidentical hematopoietic stem cell transplantation to prevent graft-versus-host disease (GVHD). Their findings indicated that the dosage of ATG, at 7.5 mg/kg, was equivalent to the dosage of ATLG, at 20 mg/kg, in the context of haploidentical hematopoietic stem cell transplantation. Consequently, ATLG has been extensively utilized for immunosuppressive therapy in patients with hematologic disorders undergoing hematopoietic stem cell transplantation.
A paucity of studies currently exists on the effect of ATLG on immune reconstruction after HSCT and on comparison with ATG treatment modalities. The objective of this study is to prospectively apply ATLG pretreatment in a cohort of allogeneic HSCT for malignant hematologic diseases. The study will dynamically observe the status of immune reconstruction in post-transplantation patients and compare it with a cohort of conventional combined ATG during the same period. The primary research question guiding this study is to explore the effect of ATLG on immune reconstitution after transplantation.
- Being tested
- Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)
- Keywords
- ATLG, ATG, immune reconstitution, allo-HSCT
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)Drug
Patients in the ATLG arm receive ATLG instead of ATG as part of the routine conditioning regimen before allo-HSCT; ATLG is given intravenously by infusion for 4 consecutive days, after which they undergo routine transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Anti-human T-lymphocyte rabbit immunoglobulin (ATLG) | Experimental | ATLG will be given as a substitute for ATG in the conditioning regimen for hematologic malignancy patients who are undergoing allo-HSCT Receives: Drug: Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of viral infections after hematopoietic stem cell transplantation
Incidence of CMV reactivation (CMV DNA ≥10^3) and CMV disease, incidence of EBV reactivation (incidence of EBV DNA ≥10^5) and lymphoproliferative disorders (PTLD), incidence of hemorrhagic cystitis, incidence of herpes simplex, adenovirus, or other viruses in both groups.
Measured: From enrollment to 1 year after allo-HSCT
Secondary outcomes (9)
Incidence and severity of acute GVHD (aGVHD)
Acute GVHD is assessed and graded based on the modified Glucksberg criteria or the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, which evaluate the degree of involvement of the skin, gastrointestinal tract, and liver. Severity is classified as grade I (mild), II (moderate), III (severe), or IV (life-threatening). The cumulative incidence of overall aGVHD, as well as grade II-IV and grade III-IV aGVHD, will be evaluated at day 100 post-transplantation.
Measured: From enrollment to the 100days after transplantation
Incidence and Severity of Chronic Graft-Versus-Host Disease (cGVHD)
Chronic GVHD is diagnosed and graded according to the National Institutes of Health (NIH) consensus criteria, which classify cGVHD as mild, moderate, or severe based on the number of organs involved and the degree of functional impairment in each affected organ. The cumulative incidence of cGVHD will be evaluated at 6 months, 12 months, and 24 months post-transplantation
Measured: With a minimum follow-up of 2 years for all enrolled patients
Immune Reconstitution Profiles Post-Transplantation
Immune reconstitution is assessed by measuring the absolute counts of peripheral blood lymphocyte subsets using multi-color flow cytometry. The following cell populations are quantified: CD4+ T helper cells, CD8+ cytotoxic T cells, CD19+ B cells, and CD3-CD56+ natural killer (NK) cells. Measurements are performed at four pre-specified time points post-transplant: day 30, day 60, day 90, and day 180. The absolute counts (cells/µL) and the recovery kinetics of each lymphocyte subset will be analyzed and compared between treatment groups.
Measured: From enrollment to the one year after trandplant
Overall Survival (OS)
Overall survival is defined as the time interval from the date of hematopoietic stem cell transplantation to the date of death from any cause. Patients who are alive at the last follow-up will be censored. OS rates will be estimated using the Kaplan-Meier method and reported at 100 days, 1 year, and 2 years post-transplantation.
Measured: From enrollment to the 2 years post-transplantation.
Disease-Free Survival (DFS)
Disease-free survival is defined as the time interval from the date of hematopoietic stem cell transplantation to the date of first documented disease relapse, disease progression, or death from any cause, whichever occurs first. Patients who remain alive and in complete remission at the last follow-up will be censored. DFS rates will be estimated using the Kaplan-Meier method and reported at 1 year and 2 years post-transplantation.
Measured: From enrollment to the 2 years post-transplantation
Cumulative Incidence of Relapse (CIR)
Cumulative incidence of relapse is defined as the probability of hematologic disease recurrence after transplantation, with death from any cause without prior relapse considered as a competing risk. Relapse is defined according to standard disease-specific criteria, including bone marrow morphology, flow cytometry, cytogenetics, or molecular assays as clinically indicated. The cumulative incidence of relapse will be estimated using the competing risk method at 1 year and 2 years post-transplantation.
Measured: From enrollment to 2 years post-transplantation
Transplant-Related Mortality (TRM)
Transplant-related mortality is defined as death occurring during the post-transplant period without evidence of disease relapse or progression. Causes of death are attributed to transplantation-related complications, including but not limited to severe GVHD, infections, organ toxicity, graft failure, or other treatment-related adverse events. TRM will be estimated using the cumulative incidence method, with relapse as a competing risk, and reported at 100 days, 1 year, and 2 years post-transplantation.
Measured: From enrollment to the Transplant-Related Mortality (TRM)2 years post-transplantation
Non-Relapse Mortality (NRM)
Non-relapse mortality is defined as death from any cause other than disease relapse or progression. This endpoint is closely related to transplant-related mortality and encompasses all deaths occurring while the patient is in complete remission or without evidence of active malignancy. Competing risk analysis will be performed, with relapse treated as a competing event, and cumulative NRM rates will be estimated at 100 days, 1 year, and 2 years post-transplantation.
Measured: From enrollment to the 2 years post-transplantation.
Incidence of Adverse Events Related to ATLG Administration
Adverse events are monitored and recorded throughout the study period from the initiation of ATLG infusion through day 100 post-transplantation. Specific adverse events of interest include infusion-related reactions (e.g., chills, rigors, hypotension, or anaphylaxis), rash, fever (defined as body temperature ≥38.3°C), and shock. All adverse events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence of any adverse event, as well as the incidence of grade 3 or higher adverse events, will be summarized descriptively.
Measured: From enrollment to the 1 week of last dose of ATLG infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start3 May 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895538
- Sponsor's protocol ID
- PKUFH 2024 644-002
- Status last verified
- Dec 2025
- First submitted
- 19 Mar 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Non-Randomized, Controlled Study of the Effect of Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) Versus Anti-Thymocyte Immunoglobulin (ATG) on Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematologic Diseases
- ClinicalTrials.gov ID
- NCT06895538
- Acronym / sponsor ID
- PKUFH 2024 644-002
- Keywords
- ATLG, ATG, immune reconstitution, allo-HSCT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 3 May 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allogeneic hematopoietic stem cell transplantation is the only curative treatment for malignant hematologic diseases. However, immune rejection is a major limitation in its application. In the "Beijing Protocol", the use of granulocyte colony-stimulating factor (G-CSF) in combination with anti-thymocyte globulin (ATG) can achieve "everyone has a donor". The use of ATG, however, can interfere with the recovery of immune function after transplantation, increasing the risk of life-threatening complications such as viral infections or graft-versus-host disease. Rabbit anti-human T-lymphocyte immunoglobulin (ATLG) is currently approved for the prevention of organ transplant rejection, which is produced differently from ATG. Previous studies have shown that transplant preconditioning with ATLG is effective in preventing graft-versus-host disease and even reduces the incidence of cytomegalovirus, etc. after transplantation. In this study, we will prospectively apply containing ATLG in a cohort of allogeneic hematopoietic stem cell transplantation for malignant hematologic diseases and dynamically observe the state of immune reconstitution of patients after transplantation. We will also compare it with a matched cohort of conventional combined ATGs during the same period to explore the impact of ATLG on immune reconstitution after transplantation.
Detailed description
Hematological malignancies (referred to as malignant hematological diseases) are a class of major diseases that pose a significant threat to human health. Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains an effective, if not the sole, treatment option for hematological tumors. Due to the potential for immune rejection, HSCT has historically been constrained to HLA-compatible siblings or non-consanguineous donors, significantly restricting its clinical application. In consideration of the findings from preceding studies, Huang's research team employed the immunomodulatory property of G-CSF in conjunction with anti-thymocyte globulin (ATG) to undertake the non-in vitro eradication of T lymphocytes for haplotype-conjugate HSCT. A series of studies were published in 2004 and 2013 that utilized G-CSF in combination with ATG to facilitate HSCT implantation. These studies demonstrated a correlation between the degree of HLA non-conformity and the degree of graft-versus-host disease (GVHD). This suggests that G-CSF combined with ATG successfully crosses the human leukocyte antigen (HLA) barrier, and that haploidentical transplantation has gradually become the most clinically utilized type of transplantation. However, clinical studies and real-world results have demonstrated that the application of ATG has the potential to enhance the risk of post-transplant cytomegalovirus (CMV), EBV activation or even infection, and post-transplant lymphoproliferative disease (PTLD).
A study published in 2023 utilized a retrospective analysis of clinical outcomes to examine patients who received two distinct sources of allogeneic T-cell-depleted (ATG) transplants. The findings indicated that patients who received ATLG during transplantation exhibited a reduced incidence of cytomegalovirus (CMV) infection. In a seminal study, Wang Shunqing and colleagues investigated the role, toxicities, and effects of ATG/ATLG on transplantation complications in non-myeloablative hematopoietic stem cell transplantation. Their findings demonstrated that the administration of ATG/ATLG during non-myeloablative hematopoietic stem cell transplantation was both safe and effective. Notably, it was observed to promote the implantation of hematopoietic stem cells, reduce the incidence of acute graft-versus-host disease (aGVHD), and decrease its severity. Huang Wenrong and colleagues investigated the effectiveness and safety of ATLG/ATLG in unrelated donor allogeneic peripheral hematopoietic stem cell transplantation. The study demonstrated that ATLG significantly reduced the incidence of cGVHD, decreased the occurrence of adverse events, and effectively controlled the occurrence of aGVHD. Lu Daopei et al. investigated the effectiveness and safety of ATG/ATLG in haploidentical hematopoietic stem cell transplantation to prevent graft-versus-host disease (GVHD). Their findings indicated that the dosage of ATG, at 7.5 mg/kg, was equivalent to the dosage of ATLG, at 20 mg/kg, in the context of haploidentical hematopoietic stem cell transplantation. Consequently, ATLG has been extensively utilized for immunosuppressive therapy in patients with hematologic disorders undergoing hematopoietic stem cell transplantation.
A paucity of studies currently exists on the effect of ATLG on immune reconstruction after HSCT and on comparison with ATG treatment modalities. The objective of this study is to prospectively apply ATLG pretreatment in a cohort of allogeneic HSCT for malignant hematologic diseases. The study will dynamically observe the status of immune reconstruction in post-transplantation patients and compare it with a cohort of conventional combined ATG during the same period. The primary research question guiding this study is to explore the effect of ATLG on immune reconstitution after transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-human T-lymphocyte rabbit immunoglobulin (ATLG) | Experimental | Drug: Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)ATLG will be given as a substitute for ATG in the conditioning regimen for hematologic malignancy patients who are undergoing allo-HSCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1）Age ≧18 years, gender is not limited;
- 2）Histologically or cytologically confirmed diagnosis of malignant hematologic diseases;
- 3) First time undergoing allogeneic hematopoietic stem cell transplantation;
- 4) ECOG score 0-2;
- 5) Hepatic and renal function, cardiopulmonary function meet the following requirements.
Key exclusion criteria (5 listed)
- 1) Prior treatment with ATG, ALG, or ATLG drugs within the past six months;
- 2) Allergic to any component of ATLG or ATG;
- 3) Bacterial, viral, parasitic, or mycobacterial infections not adequately controlled by treatment, i.e., inability to undergo hematopoietic stem cell transplantation due to severe infection.
- 4) Women who are pregnant or breastfeeding, or participants of childbearing potential who are unwilling or unable to use effective methods of contraception; 5) Participants enrolled in another clinical trial (of any investigational drug or device) within 30 days prior to the subject's baseline visit. (Subjects enrolled in observational studies are eligible to participate).
- 6) Any other circumstance that, in the judgment of the investigator, may interfere with the conduct of the clinical trial and the determination of the results of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)Patients in the ATLG arm receive ATLG instead of ATG as part of the routine conditioning regimen before allo-HSCT; ATLG is given intravenously by infusion for 4 consecutive days, after which they undergo routine transplantation. | Drug | Anti-human T-lymphocyte rabbit immunoglobulin (ATLG) |
Primary outcome
Incidence of viral infections after hematopoietic stem cell transplantation
Time frame: From enrollment to 1 year after allo-HSCT
Incidence of CMV reactivation (CMV DNA ≥10^3) and CMV disease, incidence of EBV reactivation (incidence of EBV DNA ≥10^5) and lymphoproliferative disorders (PTLD), incidence of hemorrhagic cystitis, incidence of herpes simplex, adenovirus, or other viruses in both groups.
9 secondary outcomes
Incidence and severity of acute GVHD (aGVHD)
Time frame: From enrollment to the 100days after transplantation
Incidence and Severity of Chronic Graft-Versus-Host Disease (cGVHD)
Time frame: With a minimum follow-up of 2 years for all enrolled patients
Immune Reconstitution Profiles Post-Transplantation
Time frame: From enrollment to the one year after trandplant
Overall Survival (OS)
Time frame: From enrollment to the 2 years post-transplantation.
Disease-Free Survival (DFS)
Time frame: From enrollment to the 2 years post-transplantation
Cumulative Incidence of Relapse (CIR)
Time frame: From enrollment to 2 years post-transplantation
Transplant-Related Mortality (TRM)
Time frame: From enrollment to the Transplant-Related Mortality (TRM)2 years post-transplantation
Non-Relapse Mortality (NRM)
Time frame: From enrollment to the 2 years post-transplantation.
Incidence of Adverse Events Related to ATLG Administration
Time frame: From enrollment to the 1 week of last dose of ATLG infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided. Not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) in people with Leukemia and MDS, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jialin Zhu, MD (+86-13671375500, julie920219@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of viral infections after hematopoietic stem cell transplantation (time frame: From enrollment to 1 year after allo-HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.