Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDizal Pharmaceuticals
About this trial
This study will treat patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of birelentinib plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP.
Eligibility criteria
Qualifiers
Age 18-70 years
ECOG score 0-2
Pathologically confirmed DLBCL unspecified (DLBCL, NOS)
No prior anti-lymphoma therapy
Disqualifiers
Indolent lymphoma or Richter transformation, primary mediastinal lymphoma, lymphoma invading the central nervous system or high-grade lymphoma with MYC and BCL2 rearrangements.
Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to treatment.
Taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to potently induce or inhibit CYP3A enzyme activity, anti-tumor traditional Chinese medicine.
Major surgery within 4 weeks or anticipated surgery after the start of this study.
Trial design
Treatments tested in this trial
- Birelentinib
- Rituximab
- Cyclophosphamid
- Doxorubicin
- Vincristine
- Prednisone
- Placebo
Treatment groups
880 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov