Angioimmunoblastic T-cell lymphoma
Conditions
Interventions
Experimental group:The screening period is 28 days before the first dose. Induction Treatment Period: Enrolled subjects received RCHOP plus chidamide regimen every 21 days for a maximum of 6 cycles. M
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical research: fully understand and be informed about this study and sign the informed consent form in writing; Willing to follow and able to complete all trial procedures. 2. Age 18-70 years old, male and female. 3. Histopathologically confirmed angioimmunoblastic T-cell lymphoma (AITL) with positive Ig rearrangement. 4. Lugano stage is stage I-IV. 5. ECOG score is 0-2 points. 6. Life expectancy of at least 6 months in the judgment of the investigator. 7. At least one measurable lesion. For intranodal lesions, it is defined as: long diameter >=1.5cm and short diameter >=1.0cm; For extranodal lesions, the length diameter should be >=1.0cm. 8. Adequate organ and bone marrow function, no serious hematopoietic abnormalities, abnormal heart, lung, liver, kidney function and immune deficiency: a) Blood routine: absolute neutrophil count (ANC) >=1.5 *10^9 /L (1500/mm^3), platelets >=75 *10^9/L, hemoglobin >=9 g/dL (if bone marrow is involved, platelet >=50 *10^9/L, ANC >=1.0*10^9/L, hemoglobin >). =8 g/dL). b) Liver function: total bilirubin = 50% on cardiac function tests. 9. No prior treatment for AITL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except for local radiotherapy for relieving tumor-related symptoms), surgical treatment (except tumor or pathological tissue biopsy and surgical resection not for lymphoma). 10. Negative serum pregnancy test and effective contraceptive measures from signing the informed consent form until 6 months after the last chemotherapy use.
Exclusion criteria
Exclusion criteria: 1. Other types of PTCL other than AITL, or AITL with negative Ig rearrangement. 2. Known central nervous system involvement or the possibility of central nervous system involvement cannot be ruled out; or combined with hemophagocytic syndrome. 3. Those who are known to be allergic to human or murine monoclonal antibodies, or known allergies to murine products or xenoproteins; Those who have contraindications to any of the components of the CHOP regimen. 4. Participating in other clinical studies, or the first study drug administration is less than 4 weeks from the end of the previous clinical study treatment. 5. Major surgery within 28 days before starting study treatment, or other surgical creations that are judged by the investigator to have poor healing. 6. Previous organ transplantation or hematopoietic stem cell transplantation. 7. Unstable cardiovascular function (any of the following): a. Symptomatic ischemia; b. Uncontrolled clinically significant conduction abnormalities; c. Congestive heart failure graded >=3 by the New York Cardiac Function Association; d. Myocardial infarction within 3 months. e. Primary cardiomyopathy (eg, dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unscheduled cardiomyopathy). f. History of clinically significant QTc prolongation, or QTc interval > 470 ms (females) and > 450 ms (males) at the screening period. g. Coronary heart disease with symptoms requiring medication during the screening period. h. Other cardiovascular diseases judged by the investigator to be unsuitable for enrollment. 8. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. 9. Patients with active chronic hepatitis B or active hepatitis C. Patients who are positive for hepatitis B surface antigen or hepatitis C virus antibody during the screening period must have a further hepatitis B virus DNA droplet test (no higher than 1000IU/ml) and HCV RNA test (which shall not exceed the lower limit of the assay). Hepatitis B virus carriers, hepatitis B stable after drug therapy, and cured hepatitis C patients can be enrolled. 10. Has active tuberculosis, or has a history of interstitial lung disease, such as pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest CT or MRI. 11. Presence of any active infection requiring systemic anti-infective therapy, including but not limited to bacterial, fungal, or viral infections. 12. Previous or current concomitant other malignant tumors, except for adequately treated basal cell carcinoma of the skin or squamous cell carcinoma, carcinoma in situ of the cervix. 13. Use of any monoclonal antibody within 3 months before the first dose. 14. Glucocorticoid medication >30mg/day prednisone or equivalent for other purposes other than lymphoma symptom control; The following permitted enrollment situations are subject to the following requirements: (1) If receiving corticosteroid therapy, i.e., <=30mg/day prednisone or equivalent, must have documented evidence of stable medication use for at least 4 weeks prior to the start of cycle 1; (2) If glucocorticoid therapy is urgently needed to control lymphoma symptoms before the first dose, up to doprednisone 100mg or equivalent can be used for up to 7 days, but all tumor evaluations must be completed before the start of glucocorticoid therapy. 15. Severe peripheral or central nervous system dise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression Free Survival;Overall Survival;Adverse Event;Serious Adverse Event; | — |
Countries
China
Contacts
Public ContactYang Haiyan
Zhejiang Cancer Hospital
Outcome results
None listed