T-cell acute lymphoblastic leukemia/lymphoma
Conditions
Interventions
Test group: Citabine
Control group:None
Sponsors
Xinqiao Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient was diagnosed as high-risk T-cell acute lymphoblastic leukemia/lymphoma (T-ALL), and the first complete remission (CR1) after induction chemotherapy was accompanied by one or more of the following high-risk characteristics: a) Age>30 years old; b) WBC count increase > 100 × 109/L c)ETP-ALL d) Poor prognosis of genetics or gene expression profile; e) The time to obtain CR after induction treatment was>4 weeks; e) MRD was positive after induction therapy; And patients who did not reach remission (NR) after the first induction chemotherapy and patients with complete remission (CR = 2) for the second time or more; 2. Within 45-60 days after transplantation, start to use the study drug Cedarbenamine for treatment; 3. The age when signing the ICF is = 18 years old and = 65 years old; 4. KPS score>60 points or ECOG score 0~2 points; 5. The expected survival period is more than 3 months; 6. For recipients of allogeneic hematopoietic stem cell transplantation who have received myeloablative or non-myeloablative pretreatment scheme, the pretreatment scheme shall be determined by the researcher; 7. Reaching the hematopoietic reconstitution standard within 28 days after transplantation (absolute neutrophil count (ANC) = 0.5 × 109/L for 3 consecutive days for granulocyte transplantation; PLT=20 × 109/L for 7 consecutive days and separated from platelet transfusion for platelet implantation); 8. No central nervous system involvement and clinical symptoms; 9. There is no serious damage to the function of important organs of the whole body; 10. Fully understand and know the study and sign the informed consent form (ICF); Willing to follow and able to complete all test procedures; 11. Women with fertility must conduct serum pregnancy test within 7 days before the first medication, and the result is negative; The fertile female subjects and their partners should agree to take effective contraceptive measures within 6 months after signing the ICF and using the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated liver insufficiency, renal insufficiency, gastrointestinal insufficiency, etc; 2. Clinically uncontrolled active infection (including bacterial, fungal or viral infection), and drug treatment is ineffective; 3. They are participating in other clinical studies or plan to start the treatment of this study less than 4 weeks from the end of the treatment of the previous clinical study; 4. Those with other malignant tumors that need treatment; 5. Class III-IV active aGVHD; 6. Have a history of allergy to cedabamide; 7. Pregnant or lactating women; 8. Patients with known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome; 9. Patients with active chronic hepatitis B or active hepatitis C; 10. History of prolonged QT interval syndrome; 11. Patients who are not considered suitable for this study by other researchers.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| GVHD;Overall survival;Leukemia free survival;security; | — |
Primary
| Measure | Time frame |
|---|---|
| 2-Years GRFS; | — |
Countries
China
Contacts
Public ContactLei Gao
Xinqiao Hospital of Army Medical University
Outcome results
None listed