Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07609862 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of May 30, 2026 to Jul 14, 2026v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 30, 2026 to Jul 14, 2026
  2. Study title shortened, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Guangzhou Lupeng Pharmaceutical Company LTD.
13 trials monitored
See 2 trials at risk
Leukemia
2,566 trials monitored
See 143 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
DLBCL
650 trials monitored
See 38 trials at risk
and 3 more diseases
BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib/II clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.
Trial Details
NCT Number NCT07609862
Lead Sponsor Guangzhou Lupeng Pharmaceutical Company LTD.
Conditions Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL), Waldenström Macroglobulinemia (WM), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov