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This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL.
This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL. The primary end point is PFS, and second end point is OS, ORR and toxicities according to CTCAE 5.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rituximab combined with chidamde and lenalidomide | Experimental | rituximab and chidamide, lenalidomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | a new chemotherapy regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression free survival | From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | overall response rate | From enrollment until date of completion of chemotherapy, assessed up to 9 months |
| toxicities | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
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Inclusion Criteria:
Liver function: ALT, AST≤2.5 times the normal upper limit, if there is liver metastasis, ≤5 times the normal upper limit;Total bilirubin, direct bilirubin ≤1.5 times the normal upper limit.
Bone marrow function (growth factor should not be used within 7 days before the first medication) : WBC ≥2.0*109/l;The ANC acuity 1.0 * 109 / l;PLT 50 * 109 / l or higher;Hb 8 g/dl or higher.
Renal function: creatinine ≤1.5 times the normal upper limit or creatinine clearance ≥30ml/min.
Cardiac function: LVEF≥50%. Lung function: resting and oxygen saturation ≥95% without oxygen inhalation. Coagulation function: international standardized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless the patient is receiving anticoagulation therapy and the coagulation parameters (prothrombin time [PT/INR] and aPTT) at the time of screening are within the expected range of anticoagulant treatment.Patients whose prolongation of PT or elevation of INR resulted from the use of clotting factor inhibitors were eligible for inclusion by the investigator.
Exclusion Criteria:
3, Known human immunodeficiency virus (HIV) infection, or reflect the activity of hepatitis b virus (HBV) or hepatitis c virus (HCV) infection of serological status: a. the hepatitis b surface antigen (HBsAg) positive, HBcAb positive, HBsAg positive patients should be detected HBV - DNA, if not more than 1000 iu/ml and agreed to accept patients treated against HBV virus can enter the group.B. patients with positive HCV antibody are admitted if HCV RNA (<15 IU/mL) is not detected.
4. Patients with heart failure of grade 3 or 4 according to the New York society of cardiology (NYHA) functional classification, unstable angina, severe poorly controlled ventricular arrhythmia, electrocardiogram showing acute ischemia or myocardial infarction 6 months prior to screening.Or other cardiac dysfunction assessed by the investigator as not resistant to chemotherapy.
5. Support the treatment of refractory nausea, vomiting, chronic gastrointestinal diseases, capsule dysphagia, or previous surgical resection of the intestinal segment may affect the full absorption of drugs.
6. The investigator's judgment or other evidence indicates that the patient has serious or poorly controlled systemic diseases, including poorly controlled hypertension and an active bleeding constitution.At present, patients with thrombotic diseases such as pulmonary embolism and deep vein thrombosis are also not suitable to participate in this study.
7. Nursing or pregnant women. 8. The researcher judged that the patient had other factors that might affect the compliance of the plan.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Li, MD | Contact | +8615267115611 | licong@zjcc.org.cn | |
| Yan Ha Yang, PhD | Contact | +8613857182590 | Yanghy@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Chen, PhD | Zhejiang Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42124356 | Derived | Li C, Lei T, Xu X, Lu J, Zhu X, Chen Z, Weng X, Yu H, Chen X, Peng S, Han S, Yang H. RCLARITY: A Prospective Phase II Study of Rituximab Combined With Lenalidomide and Chidamide (RLC) for the Treatment of Relapsed/Refractory Angioimmunoblastic T-Cell Lymphoma. Am J Hematol. 2026 May 12. doi: 10.1002/ajh.70366. Online ahead of print. |
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| ID | Term |
|---|---|
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| from enrollment to 30 days after completion of chemotherapy, assessed up to 9 months |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |