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Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)

ConditionDiffuse Large B-Cell Lymphoma (DLBCL)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Birelentinib

    Drug

    Specified dose on specified days

  • Rituximab

    Drug

    Specified dose on specified days

  • Cyclophosphamid

    Drug

    Specified dose on specified days

  • Doxorubicin

    Drug

    Specified dose on specified days

  • Vincristine

    Drug

    Specified dose on specified days

  • Prednisone

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

Treatment groups

880 Participants
are divided into 2 treatment groups
Group A: Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)Experimental treatment 6 interventions
Group B: Placebo + R-CHOPPlacebo comparator 6 interventions

Trial outcomes

Primary outcomes

1

Part A: Incidence and severity of adverse events

Time frame
Up to 2 years
2

Part B: Progression-free survival (PFS)

Time frame
Up to 5 years

Secondary outcomes

1

Part A: Objective response rate (ORR)

Time frame
Up to 5 years
2

Part A: Complete response rate (CRR)

Time frame
Up to 5 years
3

Part B: Event-free survival (EFS)

Time frame
Up to 5 years
4

Part B: Overall Survival (OS)

Time frame
Approximately 5 years

Other outcomes

Sponsors and contacts

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

Dizal Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

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