Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma

Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
Study ID
NCT06251180
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rocbrutinib — DRUG
    orally once daily in a 21-day cycle for eight cycles, and as maintenance for 2 years.
  • Rituximab — BIOLOGICAL
    375 mg/m2 administered intravenously once on Day 1 in a 21-day cycle for eight cycles.
  • Cyclophosphamide — DRUG
    750 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
  • doxorubicin — DRUG
    50 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
  • Vincristin — DRUG
    1.4 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
  • Prednisone — DRUG
    100 mg orally once on Day 1 to Day 5 in a 21-day cycle for six cycles.

Study Details

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 \[Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)\].

Key Dates

Start date
Apr 10, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2029

Study Design

Enrollment
112 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Patients with DLBCL or MCL or MZL receive Rocbrutinib（at escalating dose）+R-CHOP
  • Experimental: Dose Expansion [non-GCB DLBCL]
    Patients with non-GCB DLBCL receive Rocbrutinib（at recommended dose )+R-CHOP
  • Experimental: Dose Expansion [MCL]
    Patients with MCL receive Rocbrutinib（at recommended dose )+R-CHOP
  • Experimental: Dose Expansion [MZL]
    Patients with MZL receive Rocbrutinib（at recommended dose )+R-CHOP

Primary Outcome Measure

MTD [ Time Frame: Up to 21 days after the initial dose ]

Central Contacts

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