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 range20 Years
SexALL
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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:
✕. LVEF of \< 50% by echocardiography or MUGA scan
✕. 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
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