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New treatment option for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official title DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
ClinicalTrials.gov ID: NCT06539182
What this study is testing
What is DZD8586?
DZD8586 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma.
Also referred to as Birelentinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants who meet all the following criteria:
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2.
- Confirmed diagnosis of CLL/SLL with indication for treatment.
- Adequate bone marrow reserve and organ system functions.
You likely can't join if
- Participants who meet any of the following criteria:
- CNS involvement or Richter transformation.
- Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies...
- Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A...
- Active infection.
See the full eligibility criteria
- Participants who meet all the following criteria:
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2.
- Confirmed diagnosis of CLL/SLL with indication for treatment.
- Adequate bone marrow reserve and organ system functions.
- Willing to comply with contraceptive restrictions.
- Participants who meet any of the following criteria:
- CNS involvement or Richter transformation.
- 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.
- Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- 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.
- Active infection.
- Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
- Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- 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.
- Women who are breast feeding.
- History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guandong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Linyi, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shangxi, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guandong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.