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New treatment option for Chronic Lymphocytic Leukemia
Official title Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL
ClinicalTrials.gov ID: NCT04494503
What this study is testing
What is APG-2575?
APG-2575 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for chronic lymphocytic leukemia.
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
- The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed/refractory CLL/SLL.
- 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
- people who meet each of the following are eligible to participate in this study:
- Age ≥18 years old.
- Diagnosis as relapsed/refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma according to the IWCLL NCI-WG guidelines revised in 2008.
- Through radiological assessment, people with a lymph node length ≥ 10 cm require prior approval from the sponsor before enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1.
You likely can't join if
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy within 24 months or autologous hematopoietic stem...
- Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.
- Receive any of the following treatments within 14 days or 5x half-life before the first dose of study drug, or clinically significant adverse...
- Use the following drugs within 14 days before the first dose of study drug: moderately potent CYP3A inhibitors such as fluconazole, ketoconazole and...
- Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28...
See the full eligibility criteria
- people who meet each of the following are eligible to participate in this study:
- Age ≥18 years old.
- Diagnosis as relapsed/refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma according to the IWCLL NCI-WG guidelines revised in 2008.
- Through radiological assessment, people with a lymph node length ≥ 10 cm require prior approval from the sponsor before enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1.
- QTcF interval ≤450ms in males, and ≤470ms in females.
- Adequate bone marrow function independent of growth factor and transfusion.
- Adequate renal and liver function.
- 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...
- Pregnancy test results of serum samples obtained within 14 days before the first study drug administration in fertile female people were negative; If the serum pregnancy test results obtained are\> 7 days from the first...
- Male people must avoid sperm donation throughout the treatment period and for at least three months following the last dose of study drug.
- 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).
- Willingness and ability to comply with study procedures and follow-up examination.
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy within 24 months or autologous hematopoietic stem cell transplantation within 12 months.
- Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.
- 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 ≤...
- 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...
- 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...
- Received Bcl-2 inhibitor treatment.
- Invasive NHL transformation or central nervous system (CNS) involvement. has occurred.
- Cardiovascular disease of grade ≥2 (New York Heart Association Class).
- 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...
- Warfarin or other anticoagulants is required.
- Known to be allergic to study drug ingredients or their analogues.
- Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
- 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).
- Has malabsorption syndrome or other conditions that are not suitable for enteral administration.
- 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...
- 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).
- Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Zhenzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Guiyang, Guizhou, China; Shijiazhuang, Hebei, China and 9 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.