Experimental lymphoma drug ASTX660 tested in tiny, terminated trial
NCT ID NCT04362007
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested the drug ASTX660 in just 8 people with T-cell lymphoma that had returned or not responded to prior treatments. The study aimed to find a safe dose and check for side effects, but it was stopped early. Because it was so small and incomplete, we cannot draw firm conclusions about whether ASTX660 works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ASTX660
- What this could lead to
- If it works, this could point toward a new treatment option for people with T-cell lymphoma that has not responded to other therapies.
- What could go wrong
- This was a very early, small trial that was terminated early, so we don't have enough data to know if ASTX660 is safe or effective. Many early-stage cancer drugs fail in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
8 people
The number who actually took part.
- Started
-
Jul 2020
- Finished
-
Nov 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with T-cell lymphoma with histological diagnosis based on WHO classification (2017) 2. Patients with evaluable lesions. 3. Patients with ECOG PS score of 0 or 1. 4. 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 Criteria: 1. Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals 2. Patients with heart disease that meets the followings: 1. LVEF of \< 50% by echocardiography or MUGA scan 2. Congestive heart failure (NYHA classification III or IV) 3. Uncontrolled heart disease including unstable angina pectoris or hypertension considered to require hospitalization within last 3 months (90 days) 4. Complete left bundle branch block, III degree (complete) atrioventricular block, use of pacemaker, history or complication of poorly controlled arrhythmia requiring treatment 5. History or complication of long QT syndrome 6. History or complication of ventricular arrhythmia requiring active treatment 7. Corrected QT interval of ≥ 470 msec based on 12-lead ECG performed at the screening 8. Concern on increased cardiac risk by participating in the study based on medical judgment 3. Patients receiving the following treatment for the primary disease prior to the initial dose of study drug 1. Chemotherapy or radiotherapy within last 3 weeks 2. Skin directed therapy including local treatment or phototherapy within last 3 weeks 3. Treatment with monoclonal antibody within last 4 weeks 4. Treatment with other study drugs or study treatment within last 3 weeks or 5 half-lives, whichever is longer 4. 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 5. 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. 6. Patients with Inadequately controlled diabetes mellitus
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Yamagata University Hospital
Yamagata, Japan
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