Trial Title:
DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
NCT ID:
NCT06539182
Condition:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DZD8586
Description:
Daily oral dose of DZD8586 at 25 mg.
Arm group label:
Daily dose of DZD8586 at 25 mg
Intervention type:
Drug
Intervention name:
DZD8586
Description:
Daily oral dose of DZD8586 at 50 mg.
Arm group label:
Daily dose of DZD8586 at 50 mg
Intervention type:
Drug
Intervention name:
DZD8586
Description:
Daily oral dose of DZD8586 at 75 mg.
Arm group label:
Daily dose of DZD8586 at 75 mg
Summary:
This study will treat patients with CLL/SLL whose disease comes back or is not responding
to prior therapy, or if they can not bear side effects of the prior treatment. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participants who meet all the following criteria:
1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
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 or Richter transformation.
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 or abnormalities. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100053
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510280
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dalian
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Linyi
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Not yet recruiting
Start date:
April 29, 2024
Completion date:
March 2028
Lead sponsor:
Agency:
Dizal Pharmaceuticals
Agency class:
Industry
Source:
Dizal Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06539182
