A Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination with R-CHOP in Patients with Newly Diagnosed B-NHL

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Participants was histopathologically diagnosed with any of the following diseases: DLBCL, MZL or MCL (if enrolled in the dose expansion phase, histological confirmation of non-GCB subtype), and have not previously received anti-tumor systemic therapy or local radiation therapy for the above diseases.

• Participants must have at least one measurable lesion.

• ECOG physical status score 0-2.

• Life expectancy ≥6 months.

• International Prognostic Index (IPI) score ≥ 2 (only participants with DLBCL in dose expansion portion).

• Adequate coagulation, liver, kidney, and hematopoietic functions:PT and APTT \<1.5x ULN; serum bilirubin \<1.5x ULN except in participants with Gilbert's syndrome who must have a serum bilirubin of \<3x ULN, AST and ALT ≤ 3x ULN or \< 5x ULN if hepatic involvement are present; serum creatinine (Scr) ≤1.5 x ULN, or calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula.; ANC≥1500/mm3, hemoglobin≥8.0 g/dL, and platelets \>100,000/mm3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician.

• Women of childbearing potential must have a negative serum or urine (beta-human chorionic gonadotropin \[beta-hCG\]) at screening.

• Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective contraceptive measures of during and after the study (90 days after the last dose of ROCBRUTINIB and 12 months after the last dose of Rituximab). Men must agree to not donate sperm during and for up to 90 days after he last dose of ROCBRUTINIB.

• Participants voluntarily enrolled and signed the informed consent form, and followed the trial treatment and visits.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yue Shen, Ph D
yshen@lupengbio.com
86-020-31605119
Time Frame
Start Date: 2024-04-10
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 112
Treatments
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
Sponsors
Leads: Guangzhou Lupeng Pharmaceutical Company LTD.

This content was sourced from clinicaltrials.gov