Not yet recruiting NCT06656221
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Obinutuzumab, Glofitamab, Bortezomib, Orelabrutinib.
- Who it may be relevant to
- Registry conditions: Mantle Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug Obinutuzumab
Obinutuzumab pre-treatment is given intravenously at a dose of 2000mg on Cycle 1 Days 1-2 - 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 - Drug Bortezomib
Bortezomib is given intravenously at a dose of 1.6 mg/m² on Days 1, 8, and 15 of Cycles 1-12. - Drug Orelabrutinib
Orelabrutinib is given orally at a dose of 150 mg daily on Days 1-21 of Cycles 1-12.
Primary outcome measures
- Complete Response (CR) Rate [Time frame: Up to 2 years]
Secondary outcome measures (6)
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
- Duration of Response (DoR) [Time frame: Up to 2 years]
- Duration of Complete Response (DoCR) [Time frame: Up to 2 years]
- Progression-Free Survival (PFS) [Time frame: Up to 2 years]
- Overall Survival (OS) [Time frame: Up to 2 years]
- Incidence and severity of adverse events [Time frame: Up to 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06656221 · Glo-MCL