ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL (NCT02787369) | Clinical Trial Compass
Active — Not RecruitingPhase 1
ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL
United States3 participantsStarted 2016-05
Plain-language summary
This research study is studying a drug called ACY-1215 in combination with ibrutinib or idelalisib as a possible treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have confirmed CLL/SLL relapsed after at least one prior therapy and currently in need of treatment by IWCLL 2008 criteria
* Age ≥ 18
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* For the ibrutinib arm only: participants must not currently require ongoing anticoagulation for any reason, or have had any major bleeding events within 6 months of enrollment
* Participants must have normal organ and marrow function as defined below:
* Absolute neutrophil count (ANC) \> 1000 K/μL and platelet count \> 30,000 K/μL independent of transfusion support.
* total bilirubin \< 2X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilbert's syndrome
* AST(SGOT)/ALT(SGPT) ≤3X institutional upper limit of normal for ibrutinib arm; within normal limits on the idelalisib arm
* creatinine \< 2X ULN
* Participants must have measurable disease, including at least one of the following: an absolute B cell count \> 5000/uL, OR lymphadenopathy with at least one lymph node \> 2 cm in long axis, OR palpable splenomegaly, OR cytopenias (Hb \< 11 g/dL or platelets \< 100K) together with bone marrow infiltration
* The effects of the drugs studied in this research protocol on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.