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

ConditionLarge B-cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with newly diagnosed large B-cell lymphoma confirmed by histopathology, CD20-positive, excluding central nervous system lymphoma;

Patients aged 18 to 75 years;

International Prognostic Index score of 2 to 5;

Patients with high BCL-2 expression or double-hit lymphoma characteristics;

Disqualifiers

Prior solid organ transplantation or stem cell transplantation;

Complicated with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases, etc.;

Suspected active or latent tuberculosis (confirmed by a positive interferon-gamma release assay);

Neutrophils < 1.0×10⁹/L;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Sonrotoclax + Pola-R-CHPExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) of sonrotoclax in combination with Pola-R-CHP

The MTD is defined as the highest dose at which the incidence of dose-limiting toxicity (DLT) is less than 1/3 of patients.

Time frame
From first dose through 21 consecutive calendar days after reaching the target dose (up to 26 days)
2

Recommended Phase II Dose (RP2D)

The determined Maximum Tolerated Dose (MTD) and its dosing regimen will serve as the recommended Phase II dose (RP2D) for the combination regimen, unless safety data support the use of a lower dose.

Time frame
At completion of the DLT evaluation period, up to 26 days
3

Complete response rate

CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately)

Time frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Secondary outcomes

1

Objective response rate

ORR at treatment completion or discontinuation defined as the proportion of participants with CR or partial response (PR) at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately)

Time frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
2

Progression-free survival

PFS, defined as the time from diagnosis to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator

Time frame
From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)
3

Overall survival

OS defined as the time from diagnosis to death from any cause

Time frame
up to approximately 3 years
4

Duration of Response

The time from the first documentation of a complete response (CR) or partial response (PR) to the first documentation of disease progression (PD), death from any cause, or the last follow-up, whichever occurs first.

Time frame
From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: