Clinical Trials Logo

Clinical Trial 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)].


Clinical Trial Description

OUTLINE: Dose escalation portion(Part A): In the dose escalation portion of the study, the escalating doses of Rocbrutinib combined with R-CHOP may be explored, using the 3+3 principle for dose determination. If dose escalation is acceptable, and subsequently will determine the recommended Phase 2 dose. Dose expansion portion(Part B): This will be conducted as a multicenter, open-label study, including three cohorts(Cohort 1: non-GCB DLBCL; Cohort 2: MZL; Cohort 3: MCL). Eligible subjects will receive Rocbrutinib combined with R-CHOP for 6 cycles, then Rocbrutinib plus Rituximab for 2 cycles, and followed by Rocbrutinib maintenance for 2 years. After completion of study treatment, patients are followed up every 12 weeks for 1 year, then every 24 weeks for 4 year. PRIMARY OBJECTIVES: I. To evaluate the safety of Rocbrutinib in combination to R-CHOP in B-cell Non-Hodgkin Lymphoma, including the maximum tolerated dose (MTD), dose limiting toxicities(DLT), adverse events (AEs), clinically significant laboratory abnormalities. 2. To determine the recommended dose. 3. To determine the pharmacokinetic characteristics of Rocbrutinib in combination to R-CHOP. SECONDARY OBJECTIVES: I. To determine the overall response rate, the complete response rate, duration of remission, survival outcomes (progression free survival, event free survival, overall survival) in DLBCL/ Non-germinal Center(non-GCB) DLBCL. 2. To determine the overall response rate, the complete response rate, duration of remission, survival outcomes (progression free survival, event free survival, overall survival) in MZL. 3. To determine the overall response rate, the complete response rate, duration of remission, survival outcomes (progression free survival, event free survival, overall survival) in MCL. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06251180
Study type Interventional
Source Guangzhou Lupeng Pharmaceutical Company LTD.
Contact Yue Shen, Ph D
Phone 86-020-31605119
Email yshen@lupengbio.com
Status Recruiting
Phase Phase 1
Start date April 10, 2024
Completion date December 31, 2029

See also
  Status Clinical Trial Phase
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Active, not recruiting NCT03671018 - A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT00992446 - Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma Phase 2
Completed NCT03263637 - Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies Phase 1
Active, not recruiting NCT02633111 - DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas
Terminated NCT02151903 - Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL Phase 1/Phase 2
Completed NCT01919619 - Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies Phase 2
Terminated NCT01874288 - A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL Phase 1/Phase 2
Completed NCT02847130 - Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology
Suspended NCT03704714 - Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma Phase 1/Phase 2
Recruiting NCT05053971 - Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors and Lymphomas Phase 1/Phase 2
Completed NCT03677141 - A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT02981914 - Pilot Study of Pembrolizumab Treatment for Disease Relapse After Allogeneic Stem Cell Transplantation Early Phase 1
Completed NCT03483688 - A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects Phase 1
Terminated NCT05107856 - PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies Phase 1
Recruiting NCT06191887 - B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies Phase 1
Active, not recruiting NCT05201248 - A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma Phase 1
Terminated NCT03195010 - Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia Phase 2
Recruiting NCT06052826 - Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study Phase 2
Completed NCT02424968 - CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma Phase 2