Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL

Launched by ASCENTAGE PHARMA GROUP INC. · Jul 30, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called APG-2575 for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The goal is to understand how safe the treatment is and how well it works, either on its own or when combined with other therapies. The trial is currently recruiting participants who are at least 18 years old and have a confirmed diagnosis of CLL or SLL. Some important health criteria include having good overall health and functioning organs, as well as the ability to comply with study requirements.

Participants in this trial will receive the new treatment and will have regular check-ups to monitor their health and response to the medication. It's important to note that there are specific health conditions that may exclude someone from participating, such as recent major surgeries, other serious health issues, or certain previous treatments. If you or a loved one is considering participation, it’s essential to discuss any medical history and current health status with the research team to determine eligibility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects who meet each of the following inclusion criteria are eligible to participate in this study:
• • 1. Age ≥18 years old.
• • 2. Diagnosis as relapsed/refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma according to the IWCLL NCI-WG guidelines revised in 2008.
• • 3. Through radiological assessment, subjects with a lymph node length ≥ 10 cm require prior approval from the sponsor before enrollment.
• • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1.
• • 5. QTcF interval ≤450ms in males, and ≤470ms in females.
• • 6. Adequate bone marrow function independent of growth factor and transfusion.
• • 7. Adequate renal and liver function.
• • 8. Willingness by males, female patients of child bearing potential, and their partners to use contraception by effective methods throughout the treatment period and for at least three months following the last dose of study drug.
• • 9. Pregnancy test results of serum samples obtained within 14 days before the first study drug administration in fertile female subjects were negative; If the serum pregnancy test results obtained are\> 7 days from the first administration, urine sample obtained before the first study dose of study drug must be negative.
• • 10. Male subjects must avoid sperm donation throughout the treatment period and for at least three months following the last dose of study drug.
• • 11. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).
• • 12. Willingness and ability to comply with study procedures and follow-up examination.
• Exclusion Criteria:
• Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
• • 1. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy within 24 months or autologous hematopoietic stem cell transplantation within 12 months.
• • 2. Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.
• • 3. Receive any of the following treatments within 14 days or 5x half-life before the first dose of study drug, or clinically significant adverse reactions / toxicities due to previous treatments have not recovered to ≤ Grade 1: Anti-tumor therapies include chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment; investigational treatment, including targeted small molecule drugs.
• • 4. Use the following drugs within 14 days before the first dose of study drug: moderately potent CYP3A inhibitors such as fluconazole, ketoconazole and clarithromycin; moderately potent CYP3A inducers such as rifampin, carbamazepine, phenytoin And St. John's wort.
• • 5. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
• • 6. Received Bcl-2 inhibitor treatment.
• • 7. Invasive NHL transformation or central nervous system (CNS) involvement. has occurred.
• • 8. Cardiovascular disease of grade ≥2 (New York Heart Association Class).
• • 9. A significant history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular or liver disease. The investigator believes that participating in this study will have an adverse effect on him / her. For subjects requiring intervention for any of the above diseases in the past 6 months, the investigator and the sponsor must discuss.
• • 10. Warfarin or other anticoagulants is required.
• • 11. Known to be allergic to study drug ingredients or their analogues.
• • 12. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
• 13. Within 3 years before entering the study, the subject had a history of active malignant tumors other than CLL / SLL, except that:
• • Fully treated cervical carcinoma in situ;
• • Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
• • confinement and resection of previously cured malignancies (or other treatment).
• • 14. Has malabsorption syndrome or other conditions that are not suitable for enteral administration.
• • 15. Uncontrolled other clinically significant symptoms, including but not limited to: uncontrolled systemic infections (viruses, bacteria, or fungi), including but not limited to known hepatitis B virus (HBV) surface antigens and DNA positive(HBV-DNA≥2000copies/mL or ≥500IU/mL); Hepatitis C virus (HCV) antibody positive or RNA positive; human immunodeficiency virus (HIV) antibody positive; Febrile neutropenia occured within 1 week before administration.
• • 16. Primary active autoimmune diseases and connective tissue diseases, such as active and uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP).
• • 17. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.