Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma
A Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-NHL
Guangzhou Lupeng Pharmaceutical Company LTD.
112 participants
Apr 10, 2024
INTERVENTIONAL
Summary
This is an open-label, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell Non-Hodgkin Lymphoma \[Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)\].
Eligibility
Plain Language Summary
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Interventions
orally once daily in a 21-day cycle for eight cycles, and as maintenance for 2 years.
375 mg/m2 administered intravenously once on Day 1 in a 21-day cycle for eight cycles.
750 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
50 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
1.4 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
100 mg orally once on Day 1 to Day 5 in a 21-day cycle for six cycles.
Locations(1)
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NCT06251180