A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
About this study
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.
- Condition
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Tested
- DZD8586, Venetoclax
- Sponsor
- Dizal Pharmaceuticals
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- 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.
Exclusion 10
- 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.
Where
15 sites, 15 recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
and 9 more sites on ClinicalTrials.gov
Contact
-
Ling Zhou
0086-21-61095755 ling.zhou@dizalpharma.com
Potential match only. Final eligibility is determined by the study team.