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New treatment option for Chronic Lymphocytic Leukemia
Official title Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL
ClinicalTrials.gov ID: NCT05147467
What this study is testing
What is APG2575?
APG2575 is an investigational medicine, given as an once-daily pill taken by mouth, 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 efficacy and safety of APG-2575 single agent 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.
- Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.
- Expected survival is at least 12 weeks.
- Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable...
You likely can't join if
- people 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 or autologous hematopoietic stem cell...
- Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28...
- Received Bcl-2 inhibitor treatment.
- Invasive NHL transformation or central nervous system (CNS) involvement has occurred.
- Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
See the full eligibility criteria
- people who meet each of the following are eligible to participate in this study:
- Age ≥18 years old.
- Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.
- Expected survival is at least 12 weeks.
- Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2.
- 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.
- people 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 or autologous hematopoietic stem cell transplantation within 24 months.
- 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.
- Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
- Within 2 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).
- 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
- Guangzhou, Guangdong, China
- Haikou, Hainan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Tianjin, Tianjin Municipality, China
- Hanzhou, 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 Guangzhou, Guangdong, China; Haikou, Hainan, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Suzhou, Jiangsu, China; Nanchang, Jiangxi, China and 2 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.