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Pola-ZR2P in Previously Untreated DLBCL

ConditionDiffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorNavy General Hospital, Beijing

About this trial

The goal of this phase 2 trial is to test the safety and efficacy of Pola-ZR2P as induction therapy in patients with DLBCL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;

Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).

Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;

Patient is willing and able to adhere to the study visit schedule and other protocol requirements;

Disqualifiers

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.

Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.

Pregnant or lactating women

Trial design

Design model

Single group

Treatments tested in this trial

  • Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone as Induction Therapy

    Drug

    Patients were treated by Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po bid d1-21), Rituximab(375mg/m2 iv qd d1), Lenalidomide(25mg po qd d1-14) and Prednisone(60mg/m2 po qd d1-5) as induction therapy

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Pola-ZR2PExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Progression was defined according to the Lugano Response Criteria

Time frame
2 years

Secondary outcomes

1

Overall Survival (OS)

OS was defined as time from diagnosis to death from any cause or the last follow-up

Time frame
through study completion, an average of 2 years
2

Overall Response Rate (ORR)

ORR was defined as the proportion of patients who achieved CR or PR

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
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