DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2026-08-31

Brief Summary

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This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.

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Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily dose of DZD8586 at 25 mg

Group Type EXPERIMENTAL

DZD8586

Intervention Type DRUG

Daily dose of DZD8586 at 25 mg

Daily dose of DZD8586 at 50 mg

Group Type EXPERIMENTAL

DZD8586

Intervention Type DRUG

Daily dose of DZD8586 at 50 mg

Daily dose of DZD8586 at 75 mg

Group Type EXPERIMENTAL

DZD8586

Intervention Type DRUG

Daily dose of DZD8586 at 75 mg

Interventions

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DZD8586

Daily dose of DZD8586 at 25 mg

Intervention Type DRUG

DZD8586

Daily dose of DZD8586 at 50 mg

Intervention Type DRUG

DZD8586

Daily dose of DZD8586 at 75 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Participants who meet all the following criteria:

1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Histologically confirmed recurrent or refractory DLBCL.
4. Adequate bone marrow reserve and organ system functions.
5. Willing to comply with contraceptive restrictions

Exclusion Criteria

Participants who meet any of the following criteria:

1. CNS involvement
2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives. Monoclonal antibodies and antibody-drug conjugates within 28 days.
3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
5. Active infection.
6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
9. Women who are breast feeding.
10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lugui Qiu

Role: PRINCIPAL_INVESTIGATOR

National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College