Health TrialsbyHealthPanel

DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)

ConditionDiffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

This study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.

Disease stage II to IV by Ann Arbor Classification.

Life expectancy ≥ 12 months.

Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).

Disqualifiers

Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.

Prior use of BTK inhibitors.

Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.

Currently 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, proton pump inhibitor drugs, anti-tumor traditional Chinese medicine or failing to meet the protocol-specified withdrawal time before administration in this study.

Trial design

Design model

Single group

Treatments tested in this trial

  • DZD8586+R-CHOP

    Drug

    DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-CHOP (Rituximab: 375 mg/m2, IV, d1; Cyclophosphamide: 750 mg/m2, IV, d1; Doxorubicin: 50 mg/m2, IV, d1; Vincristine: 1.4 mg/m2, IV, d1; Prednisone: 100 mg, po, d1-5) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.

  • DZD8586+R-GemOx

    Drug

    DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-GemOx (Rituximab: 375 mg/m2, IV, d1; Gemcitabine: 1000 mg/m2, IV, d1; Oxaliplatin: 100 mg/m2, IV, d1) in a 21-day cycle for 8 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.

  • DZD8586+BR

    Drug

    DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with BR (Bendamustine: 90 mg/m2, IV, d1-d2; Rituximab: 375 mg/m2, IV, d1) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: DZD8586 combination therapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part A: Incidence and severity of adverse events

Time frame
Approximately 5 years
2

Part B: Objective response rate (ORR)

Time frame
Approximately 5 years

Secondary outcomes

1

Part A: Objective response rate (ORR)

Time frame
Approximately 5 years
2

Part A: Complete response rate (CRR)

Time frame
Approximately 5 years
3

Part A: Time to response (TTR)

Time frame
Approximately 5 years
4

Part A: Duration of Response (DoR)

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
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