lymphoma
Conditions
Sponsors
He'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The principle of voluntary and informed consent, sign the informed consent; 2. No gender restriction, aged 18 to 65 years, with histologically or pathologically confirmed malignant lymphoma patients; 3. Eastern Cooperative Oncology Group (ECOG) physical status: 0-1 points; the expected survival time exceeds 3 months; 4. Patients judged by the investigator to be suitable for stem cell transplantation: consolidation therapy after first-line induction chemotherapy for aggressive non-Hodgkin's lymphoma with adverse prognostic factors, it is also suitable for the salvage treatment of chemotherapy-sensitive non-Hodgkin lymphoma after relapse, and the salvage treatment of chemotherapy-sensitive relapsed or primary refractory Hodgkin lymphoma; 5. The function of major organs is normal, that is, the following criteria are met: (1) Bone marrow hematopoietic function is basically normal, blood routine (no blood transfusion within 14 days): WBC >= 3.5x10^9/L, ANC >= 1.5x10^9/L, PLT >= 80x10^9/L, Hb >= 90 g/L. If the peripheral blood index is abnormal due to lymphoma invading the bone marrow or spleen, the investigator can judge whether it is suitable for enrollment; (2) Pulmonary function: forced expiratory volume in one second (FEV1) >= 60%, diffusing capacity of carbon monoxide (DLCO) >= 50%; (3) Liver function: total bilirubin, ALT and AST are all = 60 ml/min (calculated according to the Cockcroft-Gault formula) Male subjects: CLcr = [(140-age (years) x body weight (kg))/ [72 serum creatinine (mg/dL)]]; female subjects: CLcr = 0.85 CLcr of male subjects); (5) Echocardiography or radionuclide cardiac function test, LVEF >= 55%, no uncontrolled tachycardia or fast-slow syndrome; 6. Women who are not breastfeeding, not pregnant, agree not to become pregnant during the study period and for the next 36 months. Male patients agreed that their spouses would not become pregnant during the study period and for 12 months thereafter. Women of childbearing age have a negative serum pregnancy test within 2 weeks before enrollment;
Exclusion criteria
Exclusion criteria: 1. Patients who cannot collect CD34+ cells in an amount greater than or equal to 2 x 10^6/kg; 2. Patients with known contraindications to the treatment regimen (BeEAM); 3. Clinically significant heart disease, including unstable angina pectoris, acute myocardial infarction within 6 months before screening, congestive heart failure (NYHA) cardiac function class III or IV; 4. Lymphoma patients with central nervous system (CNS) invasion; 5. Those who have received secondary or above surgery within three weeks before treatment; 6. Diagnosed with malignancy other than lymphoma or receiving treatment, except for the following cases: (1) Has received treatment for the purpose of cure, and has not experienced malignant tumors with known active disease for >=5 years before enrollment; (2) Basal cell carcinoma of the skin (except melanoma) that has received adequate treatment and has no signs of disease; (3) Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease; 7. Patients with grade 3 or higher neurotoxicity within two weeks before treatment; 8. Patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past twelve months; 9. Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBsAg positive and HBV-DNA measurable); and subjects with other acquired and congenital immunodeficiency diseases, including but not limited to patients living with HIV; 10. Patients who have received organ transplants in the past; 11. Severe active infectious diseases requiring systemic antibiotics, antifungal drugs, and antiviral therapy within 30 days before transplantation; 12. Have a history of severe neurological or psychiatric disorders, including dementia or epilepsy; 13. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the study results; 14. Patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxic and side effect;Complete response rate; | — |
Countries
China
Contacts
Public ContactLiu Zhongwen
He'nan Provincial People's Hospital
Outcome results
None listed