Malignant Hematologic Diseases
Conditions
Interventions
ATLG arm :ATLG will be given as a substitute for ATG in the conditioning regimen for hematologic malignancy patients who are undergoing allo-HSCT
Sponsors
Department of Hematology, Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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 = 45%; 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytomegalovirus (CMV) reactivation;cytomegalovirus (CMV) disease;Epstein-Barr virus (EBV) reactivation;Lymphoid tissue proliferative disease (PTLD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of acute and chronic Graft versus Host Disease;Immune reconstitution after hematopoietic stem cell transplantation; | — |
Countries
China
Contacts
Public ContactDong Yujun
Department of Hematology, Peking University First Hospital
Outcome results
None listed