Orelabrutinib in Combination With R2 Regimen for R/R CD20+ B-cell Lymphoma

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Obrutinib is a highly selective BTKi and has shown efficacy in CLL/MCL. This study aims to investigate the initial efficacy and safety of obrutinib combined with R2 regimen in the treatment of relapsed or refractory CD20+B cell lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puyang Oilfield General Hospital
• Treatments: Lenalidomide

Criteria

Inclusion Criteria:

• 1) Age ≥18 years old, ≤75 years old, gender is not limited;

2) CD20+B cell lymphoma was confirmed by histopathology, with at least one intranode lesion larger than 1.5CM in length and extranodal lesion larger than 1.0CM in diameter.

3) Patients with recurrent or refractory CD20+ B-cell lymphoma who have previously received ≥1 line and ≤5 line of different chemotherapy and/or targeted drug therapy failure and lack effective and standard treatment options;

4) ECOG strength score 0-2;

5) Medical records that have failed to respond to the latest systematic treatment (not reaching CR/PR) or disease progression after remission;

6) Major organ functions meet the following criteria:

A) Blood routine: neutrophils absolute value ≥1.5×109/L, platelets ≥75×109/L, hemoglobin ≥75g/L; Absolute neutrophils if associated with bone marrow invasion

≥1.0×109/L, platelet ≥50×109/L, hemoglobin ≥75g/L;

B) Blood biochemistry: total bilirubin ≤1.5 times ULN, AST or ALT≤3 times ULN; Serum creatinine ≤1.5 ULN; Serum amylase ≤ULN;

C) Coagulation function: International standardized ratio (INR) ≤1.5 times ULN.

7) Expected survival ≥3 months;

8) Voluntarily sign written informed consent before screening.

Exclusion Criteria:

• 1) Current or previous malignancy, unless radical therapy has been performed and there is no evidence of recurrence or metastasis in the past 5 years;

2) Non-hematologic toxicity of previous antitumor therapy did not return to ≤ grade 1 (excluding hair loss)

3) Have uncontrolled or significant cardiovascular disease

7) Had active bleeding within 2 months prior to screening, or was taking anticoagulant drugs, or was considered by the investigator to have a clear tendency to bleeding;

(8) Urine protein ≥2+, and 24 h urine protein quantification ≥ 2G /24 h;

9) History of deep vein thrombosis or pulmonary embolism;

10) The toxicity of the pre-screening treatment regimen has not recovered, and there are still toxicity reactions above grade 1;

11) Subjects with clinically significant gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;

12) A history of organ transplantation or allogeneic bone marrow transplantation;

13) Major surgery or minor surgery within 6 weeks prior to screening or 2 weeks prior to screening. Major surgery is surgery performed under general anesthesia, but endoscopic examination for diagnostic purposes is not considered major surgery. Insertion of vascular access devices will be exempt from this exclusion criterion;

14) Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive results by POLYMERase chain reaction [PCR]).

15) Current subjects with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;

16) Suitable and ready for stem cell transplantation;

17) Any mental or cognitive impairment that may limit his/her understanding, implementation and compliance with the informed consent;

18) Subjects with drug and alcohol abuse;

19) Pregnant and lactating women and subjects of childbearing age who do not want to take contraceptive measures;

20) Combined with drugs with moderate to severe inhibitory effect or strong induction effect on cytochrome P450 CYP3A;

21) Other conditions that the researcher considers unsuitable to participate in this study.