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Lymphoma, MalignantPhase 1NCT02732275

DS-3201b in Participants With Lymphomas

A Phase 1 study testing DS-3201b in people with Lymphoma, Malignant and Non-hodgkin Lymphoma, run by Daiichi Sankyo Co., Ltd. at 20 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

DS-3201b is an experimental drug that is being investigated in clinical research. Adults with non-Hodgkin lymphoma (NHL) may be able to join this study if their disease has come back after remission or is not responding to current treatment This study has three parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Malignant, Non-hodgkin Lymphoma
What is being tested?
DS-3201b
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
20 sitesin 2 countries
Study dates
31 Mar 2016to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has hematocytological or pathological diagnosis of non- Hodgkin's lymphoma (NHL)
  • Has relapsed from or is refractory to standard treatment or no standard treatment is available
  • Is the age of majority in their country (18 in the US and 20 in Japan) at the time of informed consent
  • Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Has at least one evaluable lesion site (not applicable for the DDI cohort)
  • Has preserved organ function based on baseline laboratory data at screening tests
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  • If of reproductive potential, agrees to avoid harvesting ova or sperm, and to use a protocol-defined form of contraception or avoid intercourse, during and upon completion of the study, and for at least 3 months after the last dose of study drug
  • Tumor biopsy collections:
  • willing to provide archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline
  • [US only] willing to provide fresh on-treatment tumor biopsy if deemed acceptable risk by the investigator
  • [Japan only] fresh on-treatment tumor biopsy should be performed if deemed acceptable risk by the investigator
  • willing to provide optional fresh end-of-treatment biopsy
  • For ATL subjects:
  • Has a positive test result for human T-lymphotropic virus type I antibody
  • Has ATL subtype classified as acute, lymphomatous, or chronic with poor prognostic factor
  • Has diagnosis of relapse (including relapse after partial remission [PR]) or treatment-resistant ATL at the time of informed consent after prior treatment with at least 1 anti-cancer medication regimen

Who cannot join

  • Has been diagnosed with protocol-defined cutaneous T-cell lymphoma or T-cell leukemia. For DDI cohort, CTCL is not exclusionary.
  • Has a history or presence of central nervous system (CNS) involvement
  • Has a medical history, complication or other malignancy considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study
  • Has received drugs or other treatments not allowed by the protocol
  • History of treatment with other enhancer of zeste (EZH) inhibitors
  • Has had allogeneic hematopoietic stem cell transplantation (HTCP) within 90 days before scheduled dosing on Cycle 1 Day 1
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  • Is pregnant or breastfeeding
  • Is otherwise deemed ineligible to participate by the investigator or sub-investigator
  • DDI Cohort Only:
  • Has received following medications within 14 days prior to study drug administration
  • Any CYP3A inhibitors/inducers including weak CYP3A inhibitors/inducers, and P-gp inhibitors, midazolam as well as digoxin

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States10 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • The Ohio State University Wexner Medical Center and James Cancer Hospital

    Columbus, Ohio, 43210

  • City of Hope National Medical center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Yale University

    New Haven, Connecticut, 06520

  • Weill Cornell Medicine

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

Japan10 sites

  • National Cancer Center Hospital

    Chūōku, Toyko, 104-0045

  • Imamura General Hospital

    Kagoshima, Kagoshima-ken, 890-0064

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

  • National Cancer Center Hospital East

    Kahiwa-shi, Chiba, 277-8577

  • Kumamoto University Hosipital

    Kumamoto, Kumamoto, 860-8556

  • The Institute of Medical Science, The University of Tokyo

    Minato-ku, Tokyo, 108-8639

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa, 903-0215

Other trials in Japan

About this study

Official title: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas

DS-3201b is an experimental drug that is being investigated in clinical research.

Adults with non-Hodgkin lymphoma (NHL) may be able to join this study if their disease has come back after remission or is not responding to current treatment

This study has three parts. The Dose Escalation part is designed is to find the safe dose of DS-3201b that adults with advanced NHL can tolerate. The Dose Expansion phase will determine how effective DS-3201b is for rare types of NH and collect additional safety data. Last, the Drug-Drug Interaction (DDI) Cohort (US Only) will evaluate the effect of DS-3201b on the pharmacokinetics (PK) of midazolam and digoxin when co-administered to patients with NHL

Being tested
DS-3201b
Keywords
Adult T-cell leukemia-lymphoma (ATL), Peripheral T-cell lymphoma (PTCL), Cutaneous T-cell lymphoma (CTCL), B-cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin, Leukemia-Lymphoma, Adult T-Cell, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-3201bDrug

    DS-3201 to be administered orally once daily in each 28-day cycle.

  • DS-3201bDrug

    DS-3201 to be administered orally once daily in each 28-day cycle at the recommended dose for expansion.

Study groups in NCT02732275
Study groupRoleWhat they receive
Dose Escalation - DS-3201bExperimentalDose escalation is to identify the recommended phase 2 dose of DS-3201b guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation.
Receives: Drug: DS-3201b
Dose Expansion - DS-3201bExperimentalPart 2 is a dose expansion to examine the safety and efficacy of DS-3201b.
Receives: Drug: DS-3201b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs)

    Number of DLT-evaluable participants with protocol-defined DLTs

    Measured: within 28 days after the initial dose of the study drug

  2. Dose Escalation Period: Maximum concentration (Cmax) of DS-3201

    Categories: Cycle 1 Day 1, Cycle 1 Day 15

    Measured: within the first 28-day cycle

  3. Dose Escalation Period: Time of maximum concentration (Tmax) of DS-3201

    Categories: Cycle 1 Day 1, Cycle 1 Day 15

    Measured: within the first 28-day cycle

  4. Dose Escalation Period: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201

    Measured: Day 1 of the first 28-day cycle

  5. Dose Escalation Period: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201

    Measured: Day 1 of the first 28-day cycle

  6. Dose Escalation Period: Trough (minimum) plasma concentration (Ctrough)

    Measured: Day 15 of the first 28-day cycle

  7. Dose Escalation Period: Average plasma concentration (Cavg)

    Measured: Day 15 of the first 28-day cycle

  8. DDI cohort only: Maximum concentration (Cmax) of DS-3201, midazolam, digoxin

    Categories: Day -4, Cycle 1 Day 1, Cycle 1 Day 15

    Measured: within the first 28-day cycle

  9. DDI cohort only: Time of maximum concentration (Tmax) of DS-3201, midazolam, digoxin

    Categories: Day -4, Day 0 (for alternate schedule), Cycle 1 Day 1, Cycle 1 Day 15

    Measured: within the first 28-day cycle

  10. DDI cohort only: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201,midazolam,digoxin

    Categories: Day -4, Day 0 (for alternate schedule), Cycle 1 Day 1, Cycle 1 Day 15

    Measured: within the first 28-day cycle

  11. DDI cohort only: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201, midazolam, digoxin

    Cycle 1 Day 1, Cycle 1 Day 15

    Measured: within the first 28-day cycle

  12. Number of participants with treatment-emergent adverse events (TEAEs)

    TEAEs are systematically collected from lab values, physical exams, and other investigations

    Measured: through the end of the study (within approximately 5 years)

Secondary outcomes (6)

  1. Best overall response, based on international consensus criteria

    Best overall response is defined as the percentage of participants who achieved each category as the best response, considering all overall responses assessed at all time points after the start of study treatment.

    Categories: CR, CRu, PR, SD, RD/PD, UA

    Categories: Malignant lymphoma, ATL, CTCL

    Measured: from the start of study treatment to the end of follow-up visit (within 5 years)

  2. Objective response rate (ORR)

    ORR is defined as the percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR

    Measured: within 5 years

  3. Disease control rate (DCR)

    DCR is defined as the percentage of participants who were assessed for best overall response, who achieved a best response of CR, CRu, PR, or SD

    Measured: within 5 years

  4. Duration of response (DOR)

    DOR is defined as the time from the date at which criteria are first met for CR or PR (including CRu for ATL) until the first date that progressive disease is objectively documented.

    Measured: within 5 years

  5. Progression-free survival (PFS)

    PFS is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of disease progression or death due to any cause.

    Measured: witihn 5 years

  6. Number of participants with malignant lymphoma who achieved each level of therapeutic response per international consensus standards

    Categories: Complete remission (CR), Partial remission (PR), Stable disease (SD), Relapsed disease or progressive disease (RD/PD)

    Measured: through the end of the study (within approximately 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2016 (estimated)
  2. Study start31 Mar 2016
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02732275
Sponsor's protocol ID
DS3201-A-J101
Other IDs
163173
Status last verified
Apr 2026
First submitted
4 Apr 2016
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Tachibana M, Poland B, Kakurai Y, Chen Y, Li C, Lau Y. Concentration-QTc Analysis of Valemetostat in Patients With Hematologic Malignancies. Clin Transl Sci. 2025 Nov;18(11):e70391. doi: 10.1111/cts.70391.

    PubMed 41258689

  • Tachibana M, Horwitz S, Jacobsen E, Foss F, Allen P, Porcu P, Feldman T, Ruan J, Brammer JE, Wang J, Inaba S, Iko Y, Nakajima K, Kakurai Y, Kitami N, Chen Y, Lau Y. Effect of Valemetostat on the Pharmacokinetics of Midazolam and Digoxin: A Phase 1 Drug-Drug Interaction Study in Patients With Non-Hodgkin Lymphoma. Clin Transl Sci. 2025 Nov;18(11):e70330. doi: 10.1111/cts.70330.

    PubMed 41150706

  • Maruyama D, Jacobsen E, Porcu P, Allen P, Ishitsuka K, Kusumoto S, Narita T, Tobinai K, Foss F, Tsukasaki K, Feldman T, Imaizumi Y, Izutsu K, Morishima S, Yamauchi N, Yuda J, Brammer JE, Kawamata T, Ruan J, Nosaka K, Utsunomiya A, Wang J, Zain J, Kakurai Y, Yamauchi H, Hizukuri Y, Biserna N, Tachibana M, Inoue A, Horwitz SM. Valemetostat monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma: a first-in-human, multicentre, open-label, single-arm, phase 1 study. Lancet Oncol. 2024 Dec;25(12):1589-1601. doi: 10.1016/S1470-2045(24)00502-3. Epub 2024 Oct 29.

    PubMed 39486432

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-3201b in people with Lymphoma, Malignant and Non-hodgkin Lymphoma, run by Daiichi Sankyo Co., Ltd. at 20 sites in 2 countries.

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 16 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs) (time frame: within 28 days after the initial dose of the study drug). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732275, which also lists 3 linked publications.

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 28 Apr 2026.

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