Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)Phase 1/2NCT04362007
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
A Phase 1/2 study testing ASTX660 in people with Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)
- What is being tested?
- ASTX660
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 14 Jul 2020to 30 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Multicenter, Open-Label, Nonrandomized Study to Evaluate the Tolerability and Safety of ASTX660 and the Efficacy at the Recommended Dose of ASTX660 in Patients With Relapsed or Refractory T-Cell Lymphoma
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.
- Being tested
- ASTX660
- Medical subject headings
- Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTX660Drug
Treatment of ASTX660 for r/r PTCL and r/r CTCL
ASTX660Drug
Treatment of ASTX660 for r/r ATLL
ASTX660Drug
Treatment of ASTX660 for r/r PTCL
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 dose-escalation part | Experimental | Subjects with r/r PTCL and r/r CTCL will receive ASTX660 once a day for 7 consecutive days every other week of each 28-day cycle (ie, [7 days on/ 7 days off] ×2; daily dosing on Days 1-7 and 15-21). The starting dose will be escalated stepwise in successive cohorts of 3 to 6 evaluable subjects each (standard 3+3 study design), until the RD is determined. Receives: Drug: ASTX660 |
| Phase 1 ATLL expansion part | Experimental | Subjects with r/r ATLL will receive ASTX660 at RD obtained from the Phase 1 part (dose-escalation part) once a day for 7 consecutive days every other week of each 28-day cycle. Receives: Drug: ASTX660 |
| Phase 2 | Experimental | Subjects with r/r PTCL will receive ASTX660 at RD obtained from the Phase 1 part (dose-escalation part) once a day for 7 consecutive days every other week of each 28-day cycle. Receives: Drug: ASTX660 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results
Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity.
- Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion
- Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment
- Liver-associated abnormalities
- Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours
Measured: 28 days (Day1 to Day29)
Secondary outcomes (5)
Pharmacokinetic Outcome of Concentration-time Curve (AUC)
Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
Measured: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Maximum Concentration (Cmax)
Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Measured: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax)
Assessment of pharmacokinetic parameter time to maximum concentration (Tmax).
Measured: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Elimination Half Life (t½)
Assessment of pharmacokinetic parameter elimination half life (t½).
Measured: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Clearance of Drug From Plasma
Assessment of pharmacokinetic parameter clearance of drug from plasma.
Measured: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start14 Jul 2020
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: The study was terminated early due to Sponsor decision, the decision to terminate was not based on any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)Studies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362007
- Sponsor's protocol ID
- 401-102-00001
- Other IDs
- JapicCTI-205258
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2020
- Last updated
- 25 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The focus of this study is a rare disease.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multicenter, Open-Label, Nonrandomized Study to Evaluate the Tolerability and Safety of ASTX660 and the Efficacy at the Recommended Dose of ASTX660 in Patients With Relapsed or Refractory T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04362007
- Acronym / sponsor ID
- 401-102-00001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to Sponsor decision, the decision to terminate was not based on any safety concerns.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 25 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 dose-escalation part | Experimental | Drug: ASTX660Subjects with r/r PTCL and r/r CTCL will receive ASTX660 once a day for 7 consecutive days every other week of each 28-day cycle (ie, [7 days on/ 7 days off] ×2; daily dosing on Days 1-7 and 15-21). The starting dose will be escalated stepwise in successive cohorts of 3 to 6 evaluable subjects each (standard 3+3 study design), until the RD is determined. |
| Phase 1 ATLL expansion part | Experimental | Drug: ASTX660Subjects with r/r ATLL will receive ASTX660 at RD obtained from the Phase 1 part (dose-escalation part) once a day for 7 consecutive days every other week of each 28-day cycle. |
| Phase 2 | Experimental | Drug: ASTX660Subjects with r/r PTCL will receive ASTX660 at RD obtained from the Phase 1 part (dose-escalation part) once a day for 7 consecutive days every other week of each 28-day cycle. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals
- Patients with heart disease that meets the followings:
- Patients receiving the following treatment for the primary disease prior to the initial dose of study drug
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASTX660Treatment of ASTX660 for r/r PTCL and r/r CTCL | Drug | Phase 1 dose-escalation part |
| ASTX660Treatment of ASTX660 for r/r ATLL | Drug | Phase 1 ATLL expansion part |
| ASTX660Treatment of ASTX660 for r/r PTCL | Drug | Phase 2 |
Primary outcome
Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results
Time frame: 28 days (Day1 to Day29)
Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity. 1. Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion 2. Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment 3. Liver-associated abnormalities 4. Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours
5 secondary outcomes
Pharmacokinetic Outcome of Concentration-time Curve (AUC)
Time frame: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Maximum Concentration (Cmax)
Time frame: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax)
Time frame: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Elimination Half Life (t½)
Time frame: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Pharmacokinetic Outcome of Clearance of Drug From Plasma
Time frame: Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The focus of this study is a rare disease.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobuhito Sanada study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASTX660 in people with Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results (time frame: 28 days (Day1 to Day29)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.