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New treatment option for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official title A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
ClinicalTrials.gov ID: NCT07154264
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 is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL. This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.
- 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
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2, and life expectancy ≥ 6 months.
- Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
- Patients with SLL must have at least one measurable lesion.
- Adequate bone marrow reserve and organ functions.
You likely can't join if
- Any of previous or current treatment prohibited by protocol.
- Any unresolved \> grade 1 drug-related adverse events.
- Known or suspected Richter's transformation, or prolymphocytic leukemia.
- CNS involvement.
- Active infection.
- Any of severe cardiac or pulmonary abnormalities.
See the full eligibility criteria
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2, and life expectancy ≥ 6 months.
- Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
- Patients with SLL must have at least one measurable lesion.
- Adequate bone marrow reserve and organ functions.
- Willing to comply with contraceptive restrictions.
- Any of previous or current treatment prohibited by protocol.
- Any unresolved \> grade 1 drug-related adverse events.
- Known or suspected Richter's transformation, or prolymphocytic leukemia.
- CNS involvement.
- Active infection.
- Any of severe cardiac or pulmonary abnormalities.
- Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
- Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
- Prior malignancy within the past 3 years.
- Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Yichang, Hubei, China
- Changsha, Hunan, China
- Changzhou, Jiangsu, China
- Nantong, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, 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, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Yichang, Hubei, 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.