Non-Hodgkin lymphoma
Conditions
Interventions
Experimental group:TEAM condition regimen
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Systemic non-Hodgkin lymphoma confirmed by histopathological biopsy at initial diagnosis, and meeting one of the following criteria: (1) Involvement of one of the following sites: central nervous system (excluding primary central nervous system lymphoma), intraspinal/extraspinal involvement with nerve root invasion, genital organs (uterus, breast, testis), kidney/adrenal gland, multiple extranodal sites (bone, colorectum, etc.);(2) High-risk CNS-IPI score (4–6 points). Patients with indication for autologous hematopoietic stem cell transplantation according to NCCN Guidelines, with disease status of complete remission (CR) or partial remission (PR) before transplantation, Ann Arbor stage III–IV, ECOG performance status 6 months; 2.Age between 18 and 70 years; 3.Adequate renal, hepatic, pulmonary, hematologic, and cardiac function, defined as follows: Creatinine clearance (estimated by Cockcroft-Gault formula) >=50 mL/min / serum creatinine =1.5×10^9/L, platelet count >=100×10^9/L;Left ventricular ejection fraction >=50%, no pericardial effusion confirmed by echocardiography, no clinically significant electrocardiographic abnormalities;no clinically significant pleural effusion;baseline oxygen saturation >=95% on room air; 4.Negative serum or urine pregnancy test for females of childbearing potential (females who have undergone sterilization or are postmenopausal for at least 2 years are considered not of childbearing potential). 5.Patients receiving treatment in this clinical study must use effective contraceptive measures; 6.In the investigator’s judgment, the patient is able to comply with the study protocol; 7.The patient voluntarily participates in this clinical trial, understands the study procedures, and is able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of primary central nervous system lymphoma (PCNSL); 2.Presence of another concurrent malignancy or life-threatening disease, or history of a prior malignancy that was in complete remission for less than 5 years; 3.Presence of mucositis of grade >=2; 4. Presence of congestive heart failure, poorly controlled hypertension, or unstable cardiovascular disease; 5. Presence of uncontrolled infection; 6. Development of uncontrolled disease during the study period; 7.History of prior allogeneic hematopoietic stem cell transplantation; 8. Presence of any medical condition that could potentially interfere with the evaluation of the safety or efficacy of the study treatment; 9. History of severe hypersensitivity to any study drug; 10. Females of childbearing potential who are pregnant or breastfeeding; 11.Male and female subjects unwilling to use effective contraceptive measures from the time of signed informed consent until 6 months after completion of study drug administration; 12.In the investigator’s judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative Incidence of Relapse (CIR);Non-relapse mortality (NRM);Treatment-related toxicity; | — |
Countries
China
Contacts
Public ContactYang Xu
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed