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Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2/3NCT07712588

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

A Phase 2/3 study testing Birelentinib, Rituximab and Cyclophosphamid in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Dizal Pharmaceuticals at 5 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma (DLBCL)
What is being tested?
Birelentinib, Rituximab and Cyclophosphamid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
880 participants
Where
5 sitesChina
Study dates
Sep 2026to Feb 2032
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years
  • ECOG score 0-2
  • Pathologically confirmed DLBCL unspecified (DLBCL, NOS)
  • No prior anti-lymphoma therapy
  • Ann Arbor Stages II - IV
  • IPI score ≥ 3, or IPI score 1 - 2 and LDH > 1.3 × ULN and/or lesion diameter ≥ 7 cm
  • Adequate bone marrow and organ function
  • Willing to comply with contraceptive restrictions

Who cannot join

  • 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.
  • Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
  • Active infectious diseases.
Show all 13Show fewer
  • Peripheral neuropathy ≥ Grade 2 (as defined by CTCAE version 6.0)
  • Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate absorption of the drug.
  • Diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years.
  • Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution.
  • Patients with a history of hypersensitivity to any component of the R-CHOP regimen, DZD8586 drug excipients, or other chemical analogues.
  • Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent.
  • Women who are pregnant or breastfeeding.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liu contact

+86-21-61095852

ziyi.liu@dizalpharma.com

5 sites in 1 country

China5 sites

  • Hunan Cancer Hospital

    Changsha, Hunan

    Zhou

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Liu

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Zhang

  • Cancer Hospital of Shandong Frist Medical University

    Jinan, Shangdong

    Li

  • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

    Shanghai, Shanghai Municipality

    Zhao

Other trials in China

About this study

Official title: A Phase 2/3, Randomized, Double-Blind, Multi-center Study of Birelentinib Combined With R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

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.

Being tested
Birelentinib, Rituximab, Cyclophosphamid, Doxorubicin, Vincristine
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BirelentinibDrug

    Also called DZD8586

    Specified dose on specified days

  • RituximabDrug

    Specified dose on specified days

  • CyclophosphamidDrug

    Specified dose on specified days

  • DoxorubicinDrug

    Specified dose on specified days

  • VincristineDrug

    Specified dose on specified days

  • PrednisoneDrug

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

Study groups in NCT07712588
Study groupRoleWhat they receive
Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)ExperimentalNot described
Receives: Drug: Birelentinib; Drug: Rituximab; Drug: Cyclophosphamid; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
Placebo + R-CHOPPlacebo comparatorNot described
Receives: Drug: Rituximab; Drug: Cyclophosphamid; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence and severity of adverse events

    Measured: Up to 2 years

  2. Part B: Progression-free survival (PFS)

    Measured: Up to 5 years

Secondary outcomes (7)

  1. Part A: Objective response rate (ORR)

    Measured: Up to 5 years

  2. Part A: Complete response rate (CRR)

    Measured: Up to 5 years

  3. Part B: Event-free survival (EFS)

    Measured: Up to 5 years

  4. Part B: Overall Survival (OS)

    Measured: Approximately 5 years

  5. Part B: Objective response rate (ORR)

    Measured: Up to 5 years

  6. Part B: Complete response rate (CRR)

    Measured: Up to 5 years

  7. Part B: Incidence and severity of adverse events

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJan 2031 (estimated)
  4. Study completionFeb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
880 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07712588
Sponsor's protocol ID
DZ2025B0006
Status last verified
Jul 2026
First submitted
14 Jul 2026
Last updated
5 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Birelentinib, Rituximab and Cyclophosphamid in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Dizal Pharmaceuticals at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu (+86-21-61095852, ziyi.liu@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence and severity of adverse events (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07712588.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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