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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ruijin Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
