Mantle cell lymphoma
Conditions
Interventions
Sponsors
Cancer Hospital Affiliated to Zhengzhou University-Henan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years with histologically or pathologically confirmed malignant lymphoma patients; Aged 18 to 65 years with histological or pathologically confirmed mantle lymphoma patients; with cyclin D1 Overexpression or fluorescence in situ hybridization or RT-PCR for chromosome t(11;14); 2. ECOG score: 0-3 points are required for patients aged 18-59 years, and 0-2 points are required for patients aged 60-65 years; 3. Advanced mantle cell lymphoma: Ann Arbor stage III, IV or II with tumor volume (>= 5cm) or B symptoms; 4. Measurable disease in at least one site (two diameters); 5. Patients with mantle lymphoma who are judged by the investigator to be suitable for autologous hematopoietic stem cell transplantation (complete remission and partial remission after induction chemotherapy ( >= 75% reduction after induction); 6. The autologous peripheral blood CD34+ stem cells collected for transplantation are greater than 2x10^6/kg; 7. Patients with hematological recovery within 120 days after autologous hematopoietic stem cell transplantation (blood routine: WBC >= 3.0 x 10^9/L, ANC >= 1.0 x 10^9/L, PLT >= 60 x 10^9/L). 8. Pulmonary function: forced expiratory volume in one second (FEV1) >= 60%, diffusing capacity of carbon monoxide (DLCO) >= 50%; 9. Liver function: total bilirubin, ALT and AST are all = 60 ml/min; 11. Echocardiography or radionuclide cardiac function test, LVEF >= 45%, no uncontrolled tachycardia or fast-slow syndrome; 12. Patients in childbearing period agree to take appropriate contraceptive measures. Women of childbearing age have a negative serum pregnancy test within 2 weeks before enrollment; 13. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known contraindications to zanubrutinib; 2. Those who have undergone secondary or above surgery within 4 weeks before treatment (excluding diagnostic surgery); 3. Diagnosed with other malignancies other than lymphoma or receiving treatment, except for the following cases: have received treatment for the purpose of cure, and no malignant tumor with known active disease has occurred >= 5 years before enrollment; Adequately treated basal cell carcinoma of the skin (except for melanoma) with no signs of disease; Adequately treated carcinoma in situ of the cervix with no signs of disease; 4. Patients with grade 3 or higher neurotoxicity within two weeks before treatment; 5. Evidence of central nervous system involvement; 6. Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past twelve months; 7. 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 HIV-infected persons (HBV-DNA >= 10^4); 8. Lactating women; 9. Patients who have received organ transplantation in the past; 10. Has severe active infection; 11. There are contraindications to the use of large doses of hormones, such as uncontrolled hyperglycemia, gastric ulcer or mental illness; 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 |
|---|---|
| Bone marrow aspiration and bone marrow biopsy;CT;PET-CT;blood routine examination;electrocardiogram; | — |
Countries
China
Contacts
Public ContactZhou Jian
Cancer Hospital Affiliated to Zhengzhou University-Henan Cancer Hospital
Outcome results
None listed