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

First listed
Feb 9, 2024
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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