A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma (NCT04362007) | Clinical Trial Compass
TerminatedPhase 1/2
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
Stopped: The study was terminated early due to Sponsor decision, the decision to terminate was not based on any safety concerns.
Japan8 participantsStarted 2020-07-14
Plain-language summary
Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2.
Phase 1 (ATLL expansion part): Evaluate the safety of ASTX660 at RD in patients with r/r ATLL.
Phase 2 : Evaluate the efficacy of ASTX660 at RD in patients with r/r PTCL.
Who can participate
Age range
20 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
. Patients with T-cell lymphoma with histological diagnosis based on WHO classification (2017)
. Patients with evaluable lesions.
. Patients with ECOG PS score of 0 or 1.
. Patients with adequate organ functions as shown below.
Exclusion criteria
. Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals
. Patients with heart disease that meets the followings:
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.
1This trial was terminated before completing its Phase I/II work — do you know why it was stopped, and does that affect whether ASTX660 is still considered a viable option for my type of T-cell lymphoma?
2Since this study was primarily measuring dose-limiting toxicities and safety signals in its Phase I portion, what does that tell us about how much is — or isn't — known yet about how safe and effective this drug might be?
3Given that the trial is no longer enrolling, are there other active clinical trials studying ASTX660 or similar IAP inhibitor approaches that might be worth exploring for my situation?
4Because this trial covered several different diagnoses — PTCL, CTCL, and ATLL — how relevant would any early findings from this study be specifically to my diagnosis, and should I be looking for trials focused more narrowly on my subtype?
5Before considering any experimental options like this one, should we discuss whether any currently approved or standard treatments for my condition haven't been tried yet, and how those compare to pursuing an early-phase study?
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.
What they're measuring
1
Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results
. Congestive heart failure (NYHA classification III or IV)
. Uncontrolled heart disease including unstable angina pectoris or hypertension considered to require hospitalization within last 3 months (90 days)
. Complete left bundle branch block, III degree (complete) atrioventricular block, use of pacemaker, history or complication of poorly controlled arrhythmia requiring treatment
. History or complication of long QT syndrome
. History or complication of ventricular arrhythmia requiring active treatment