A Prospective, Open-Label, Single-Arm Study of Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle Cytarabine in First-Line Treatment of Mantle Cell Lymphoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma (MCL) . The investigators propose ZGR followed by a short cycle of Obinutuzumab and cytarabine could be an effective first-line treatment for MCL.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Aged 18 to 80 years, male or female;

• Patients with pathologically (histologically or cytologically) confirmed MCL and at least one measurable lesion by Lugano criteria;

• No prior systemic therapy for MCL;

• Eastern Cooperative Oncology Group (ECOG) score of 0-2 points;

• Normal function of vital organs, i.e. meeting the following criteria:

• a) Blood routine examination must be in accordance with (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days): i. Absolute neutrophil count (ANC) ≥ 1 × 10^9/L; ii. Platelet count (PLT) ≥ 75 × 10^9/L; b) Chemistry panel must meet the following criteria: i. Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN); ii. Glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST) ≤ 2.0 × ULN iii. Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula); c) Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;

• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the start of study medication and are willing to use a medically recognized highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) during the study and within 6 months after the last dose of study drug; male subjects with partners of childbearing potential should be surgically sterile or agree to use an effective method of contraception during the study and within 6 months after the last dose of study drug;

• The subjects voluntarily participate in the study and sign the informed consent form. They have good compliance and cooperate in the follow-up.

Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Shuhua Yi
yishuhua@ihcams.ac.cn
+86-022-23909106
Backup
Lugui Qiu
qiulg@ihcams.ac.cn
+86-022-23909172
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 39
Treatments
Experimental: ZGR followed short cycle of Obinutuzumab and Cytarabine
All patients were treated with ZGR regimen for 6 cycles after enrollment, followed by 3 cycles of Obinutuzumab and Cytarabine in 28-day cycles. Obinutuzumab: 1000 mg, intravenous drip, administered on d1, d8 and d15 of the first cycle, and administered on the first day of each cycle starting from the second cycle. Zanubrutinib: 160 mg, bid, continuous oral. Lenalidomide: 20 mg/d, qd, oral, d1-d21.Cytarabine: for young tolerable patients, the dose is 2 g/m2, q12h, intravenous drip, d1-2ND for elderly/intolerant patients, the dose is 500 mg/m2, q12h, intravenous drip, completed 2-3 hours, d1-3. The specific dose is determined by the investigator according to the actual situation of the patient. Zanubrutinib for 2 years combination with Lenalidomide for 1 year was used for maintenance treatment in non-high-risk patients and in high-risk patients after recovery of hemogram 2 months after CAR-T.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov