Status:
TERMINATED
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief 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 expans...
Eligibility Criteria
Inclusion
- 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.
- AST and ALT ≤ 2.0 × ULN (≤ 3.0 × ULN if liver infiltration is present)
- Total bilirubin ≤ 1.5 × ULN
- ANC ≥ 1,000/mm3 (≥ 750/mm3 if bone marrow infiltration is present)
- Platelet count 50,000/mm3 (25,000/mm3 if bone marrow infiltration is present)
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
- Amylase and lipase ≤ 1.0 × ULN
Exclusion
- 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
- History or complication of long QT syndrome
- History or complication of ventricular arrhythmia requiring active treatment
- Corrected QT interval of ≥ 470 msec based on 12-lead ECG performed at the screening
- Concern on increased cardiac risk by participating in the study based on medical judgment
- Patients receiving the following treatment for the primary disease prior to the initial dose of study drug
- Chemotherapy or radiotherapy within last 3 weeks
- Skin directed therapy including local treatment or phototherapy within last 3 weeks
- Treatment with monoclonal antibody within last 4 weeks
- Treatment with other study drugs or study treatment within last 3 weeks or 5 half-lives, whichever is longer
- Patients with prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 14 weeks prior to the day of initial dose of study drug
- Patients who have received corticosteroids at a dose exceeding a prednisone equivalent dose of 10 mg/day within 3 weeks prior to the initial dose of study drug.
- Patients with Inadequately controlled diabetes mellitus
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04362007
Start Date
July 14 2020
End Date
November 30 2024
Last Update
January 15 2025
Active Locations (1)
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1
Yamagata University Hospital
Yamagata, Japan