Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL

Sponsor
Ruijin Hospital
Study ID
NCT07638787
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm
  • Rituximab — DRUG
    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
  • Cyclophosphamide — DRUG
    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
  • Doxorubicin — DRUG
    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
  • Prednisone — DRUG
    Prednisone PO will be administered as per the schedule specified in the respective arm.
  • Sonrotoclax — DRUG
    Sonrotoclax PO will be administered as per the schedule specified in the respective arm.

Study Details

This is a Phase I/II study. The Phase I part will evaluate the safety and tolerability of sonrotoclax in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP), using a standard 3+3 dose-escalation design, to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). The Phase II part will assess the efficacy of the combination regimen in patients with previously untreated LBCL with high BCL2 expression or MYC/BCL2 rearrangements.

Key Dates

First listed
Jun 10, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sonrotoclax + Pola-R-CHP
    Eligible participants will receive sonrotoclax plus Pola-R-CHP. In Phase I, three dose levels of sonrotoclax will be evaluated with a ramp-up schedule in Cycle 1 (Days 4-10), followed by Days 1-10 dosing at the assigned dose in subsequent cycles: 320 mg, 480 mg, and 640 mg QD. Dose escalation uses a standard 3+3 design to determine the MTD of sonrotoclax. The RP2D will be used with Pola-R-CHP in Phase II.

Primary Outcome Measure

Maximum tolerated dose (MTD) of sonrotoclax in combination with Pola-R-CHP [ Time Frame: From first dose through 21 consecutive calendar days after reaching the target dose (up to 26 days) ]

Central Contacts

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