hematological malignancies
Conditions
Interventions
Experimental group:half-dose PT/Cy+post-transplant very low-dose PT/ATG-F+CsA/FK506
Control group:CsA/FK506+MTX
Sponsors
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 15~65 years; 2. Gender: male or female; 3. Patients with hematologic malignancies assessed by the investigator as eligible for HLA-matched sibling hematopoietic stem cell transplantation, including acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, lymphoma, etc; 4. The patients are in first, second, or third complete response (CR1, CR2, or CR3), partial response (PR), non-remission (NR), or relapse after remission; 5. Patients who have an HLA-matched sibling donor and with no prior hematopoietic stem cell transplantation history; 6. ECOG score 0-2; 7. Cardiac function: ejection fraction = 50%; 8. Lung function: forced expiratory volume in one second (FEV1) = 60%, carbon monoxide dispersion (DLCO) = 50%; 9. Liver and kidney functions are normal: serum bilirubin = 34µmol/L, serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times the upper limit of normal (ULN), serum creatinine = 130µmol/L; 10.The patients agree to participate in the clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any uncontrolled active infection before transplant; 2. Severe hypersensitivity to ATG-F (anaphylactic shock or laryngeal edema); 3. Patients who have a hematopoietic stem cell transplantation history; 4. Patients with cardiac insufficiency (ejection fraction 130umol/L); 6. Patients with liver insufficiency (total bilirubin >34umol/L, ALT/AST> 2.5 ULN); 7. The patient is pregnant or breastfeeding; 8. The patients have a history of severe neurological or psychiatric problems, including dementia or epilepsy. 9. No informed consent is signed; 10. In the judgment of the principal investigator, the patients have other conditions that are not considered appropriate for inclusion in the study; 11. Other conditions that do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade II to IV acute GVHD; | — |
Secondary
| Measure | Time frame |
|---|---|
| engraftment;Incidence of infections;The incidence of grade III to IV acute GVHD;The incidence of cGVHD;Non-relapse mortality;Cumulative incidence of relapse;Overall survival;Disease-free survival;GVHD-free/ relapse-free survival; | — |
Countries
China
Contacts
Public ContactJian Zhou
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Outcome results
None listed