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New hope for blood cancer patients in japan?

NCT ID NCT06035497

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new drug called Golcadomide (BMS-986369) in about 85 people in Japan whose T-cell lymphoma has come back or not responded to treatment. The goal is to check the drug's safety and how well it works against the cancer. Participants will receive the drug and be monitored for side effects and tumor response.

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

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Oct 2030

An estimate. End dates often move.

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

18 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria \- Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:. i) Adult T-cell leukemia-lymphoma (ATL). ii) Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS). iii) Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin. iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+). v) ALCL, anaplastic lymphoma kinase-negative (ALK-). vi) Breast implant-associated ALCL. vii) Extranodal NK/T-cell lymphoma, nasal type (ENKL). viii) Mycosis fungoides (MF) with advanced stage (stage IIB-IVB). * Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator. * Phase 2 participants must have been treated by at least 1 prior line of systemic therapy. * Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2. Exclusion Criteria * Have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study. * Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study. * Have a life expectancy ≤ 3 months. * Other protocol-defined Inclusion/Exclusion criteria apply.

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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

  • Local Institution - 0001

    Sendai, Miyagi, 980-8574, Japan

  • Local Institution - 0002

    Kashiwa, Chiba, 277-8577, Japan

  • Local Institution - 0003

    Chuo-ku, Tokyo, 104-0045, Japan

  • Local Institution - 0004

    Isehara, Kanagawa, 259-1193, Japan

  • Local Institution - 0005

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • Local Institution - 0006

    Kumamoto, 860-8556, Japan

  • Local Institution - 0007

    Okayama, 700-8558, Japan

  • Local Institution - 0008

    Kagoshima, 890-8520, Japan

  • Local Institution - 0009

    Hidaka, Saitama, 350-1298, Japan

  • Local Institution - 0010

    Osaka, 541-8567, Japan

  • Local Institution - 0011

    Nagoya, Aichi-ken, 467-8602, Japan

  • Local Institution - 0012

    Fukuoka, 812-8582, Japan

  • Local Institution - 0013

    Yokosuka, Kanagawa, 238-8558, Japan

  • Local Institution - 0015

    Kagoshima, 890-0064, Japan

  • Local Institution - 0016

    Iizuka, Fukuoka, 820-8505, Japan

  • Local Institution - 0017

    Kamogawa, Chiba, 296-0041, Japan

  • Local Institution - 0018

    Fukuoka, 810-8563, Japan

  • Local Institution - 0019

    Ōmura, Nagasaki, 8568562, Japan

  • Local Institution - 0020

    Ōita, 870-8511, Japan

  • Local Institution - 0022

    Mitaka, 181-8611, Japan

  • Local Institution - 0023

    Fukuoka, 814-0180, Japan

  • Local Institution - 0024

    Toyohashi, Aichi-ken, 441-8570, Japan

  • Local Institution - 0025

    Hiroshima, 7348551, Japan

  • Local Institution - 0026

    Minato-ku, Tokyo, 105-8471, Japan

  • Local Institution - 0027

    Kyoto, 602-8566, Japan

  • Local Institution - 0028

    Sasebo, Nagasaki, 857-8511, Japan

  • Local Institution - 0029

    Itabashiku, Tokyo, 173-8610, Japan

  • Local Institution - 0030

    Nagasaki, 852-8104, Japan

  • Local Institution - 0031

    Anjo-shi, Aichi-ken, 446-8602, Japan

  • Local Institution - 0032

    Amagasaki, Hyōgo, 660-8550, Japan

  • Local Institution - 0033

    Kobe, Hyōgo, 650-0047, Japan

  • Local Institution - 0034

    Osaka, 545-8586, Japan

  • Local Institution - 0035

    Kumamoto, 860-0008, Japan

  • Local Institution - 0036

    Sapporo, Hokkaido, 0608648, Japan

  • Local Institution - 0037

    Narita, Chiba, 286-8520, Japan

  • Local Institution - 0038

    Miyazaki, 889-1692, Japan

  • Local Institution - 0039

    Hiroshima, 730-0052, Japan

  • Local Institution - 0040

    Koto, Tokyo, 135-8550, Japan

  • Local Institution - 0041

    Kitakyushu-shi, Fukuoka, 806-8501, Japan

  • Local Institution - 0042

    Okinawa, 904-2142, Japan

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