A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma

NCT ID: NCT06656221

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2028-05-01

Brief Summary

The aim of this study is to evaluate the efficacy and safety of Glofitamab combined with Orelabrutinib and Bortezomib in patients with high-risk mantle cell lymphoma

Conditions

Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glofitamab-Orelabrutinib-Bortezomib

Participants will receive 2000 mg of obinutuzumab on Days 1-2 of Cycle 1, 2.5 mg of glofitamab on Day 8 of Cycle 1, 10 mg of glofitamab on Day 15 of Cycle 1, followed by 30 mg of glofitamab on Day 1 of Cycles 2-12.

Participants will receive 1.6 mg/m² of bortezomib on Days 1, 8, and 15 of Cycles 1-12.

Participants will receive 150 mg/day of orelabrutinib on Days 1-21of Cycles 1-12.

The duration of one cycle is 21 days.

Group Type: EXPERIMENTAL

Obinutuzumab

Intervention Type: DRUG

Obinutuzumab pre-treatment is given intravenously at a dose of 2000mg on Cycle 1 Days 1-2

Glofitamab

Intervention Type: DRUG

Glofitamab is given intravenously at a dose of 2.5mg on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg on Day 1 of Cycles 2-6

Bortezomib

Intervention Type: DRUG

Bortezomib is given intravenously at a dose of 1.6 mg/m² on Days 1, 8, and 15 of Cycles 1-12.

Orelabrutinib

Intervention Type: DRUG

Orelabrutinib is given orally at a dose of 150 mg daily on Days 1-21 of Cycles 1-12.

Interventions

Obinutuzumab

Obinutuzumab pre-treatment is given intravenously at a dose of 2000mg on Cycle 1 Days 1-2

Intervention Type: DRUG

Glofitamab

Glofitamab is given intravenously at a dose of 2.5mg on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg on Day 1 of Cycles 2-6

Intervention Type: DRUG

Bortezomib

Bortezomib is given intravenously at a dose of 1.6 mg/m² on Days 1, 8, and 15 of Cycles 1-12.

Intervention Type: DRUG

Orelabrutinib

Orelabrutinib is given orally at a dose of 150 mg daily on Days 1-21 of Cycles 1-12.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed Informed Consent Form
• Age ≥ 18 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
• Participants with MCL
• Meets any of the following high-risk criteria: blastoid/pleomorphic morphology; high Ki-67 (≥ 30%); TP53 aberration; del(17p); complex karyotype; MIPI score ≥ 6.2; early progression after first-line treatment (<24 months); presence of other high-risk genetic mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1)
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
• At least one bi-dimensionally measurable (≥ 1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥ 1 cm) extranodal lesion, as measured on CT scan
• No bone marrow involvement: ANC ≥ 1.0 × 10^9/L; bone marrow involvement: ANC ≥ 0.5 × 10^9/L
• No bone marrow involvement: PLT ≥ 75 × 10^9/L; bone marrow involvement: PLT ≥ 25 × 10^9/L
• No bone marrow involvement: Hgb ≥ 8 g/dL; bone marrow involvement: Hgb ≥ 7 g/dL
• Adequate renal function, defined as measured or estimated creatinine clearance ≥ 30 mL/min

Exclusion Criteria

• Contraindication to any of the individual components of Glofit-Orela-Borte
• Known active infection at the time of enrollment
• Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology): Patients with occult or prior HBV infection (defined as negative HbsAg and positive hepatitis B core antibody [HbcAb]) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy
• Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing): Patients who are positive for HCV antibody are eligible only if PCR is negative for HCV RNA
• History of other malignancies that could affect compliance with the protocol or interpretation of results
• Active autoimmune disease requiring treatment
• Primary or secondary CNS lymphoma at the time of recruitment
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Glo-MCL

Identifier Type: -

Identifier Source: org_study_id