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
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
Treatments tested in this trial
- Polatuzumab Vedotin
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Prednisone
- Sonrotoclax
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
1Ruijin Hospital, Shanghai JiaoTong University School of Medicine200025, ShanghaiShanghai Municipality, China
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
Source ClinicalTrials.gov