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

Trial Title: 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

Condition: Mantle Cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Bortezomib
Obinutuzumab

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Obinutuzumab
Description: Obinutuzumab pre-treatment is given intravenously at a dose of 2000mg on Cycle 1 Days 1-2
Arm group label: Glofitamab-Orelabrutinib-Bortezomib

Intervention type: Drug
Intervention name: Glofitamab
Description: 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
Arm group label: Glofitamab-Orelabrutinib-Bortezomib

Intervention type: Drug
Intervention name: Bortezomib
Description: Bortezomib is given intravenously at a dose of 1.6 mg/m² on Days 1, 8, and 15 of Cycles 1-12.
Arm group label: Glofitamab-Orelabrutinib-Bortezomib

Intervention type: Drug
Intervention name: Orelabrutinib
Description: Orelabrutinib is given orally at a dose of 150 mg daily on Days 1-21 of Cycles 1-12.
Arm group label: Glofitamab-Orelabrutinib-Bortezomib

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

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 1, 2024

Completion date: May 1, 2028

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06656221