A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

Last updated: January 29, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Non-hodgkin's Lymphoma

Treatment

BMS-986369

Clinical Study ID

NCT06035497
CA073-1008
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: BMS-986369
Phase: 1/2
Study Start date:
November 20, 2023
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Local Institution - 0031

    Anjo, Aichi 446-8602
    Japan

    Site Not Available

  • Anjo Kosei Hospital

    Anjo-shi, Aichi 446-8602
    Japan

    Active - Recruiting

  • Local Institution - 0011

    Nagoya, Aichi 467-8602
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Local Institution - 0024

    Toyohashi, Aichi 441-8570
    Japan

    Site Not Available

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi 441-8570
    Japan

    Active - Recruiting

  • Kameda General Hospital

    Kamogawa, Chiba 296-0041
    Japan

    Active - Recruiting

  • Local Institution - 0017

    Kamogawa, Chiba 296-0041
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • International University of Health and Welfare Narita Hospital

    Narita, Chiba 286-8520
    Japan

    Active - Recruiting

  • Local Institution - 0037

    Narita, Chiba 286-8520
    Japan

    Site Not Available

  • Aso Iizuka Hospital

    Iizuka, Fukuoka 820-8505
    Japan

    Active - Recruiting

  • Local Institution - 0016

    Iizuka, Fukuoka 820-8505
    Japan

    Site Not Available

  • Japan Community Healthcare Organization Kyushu Hospital

    Kitakyushu-shi, Fukuoka 806-8501
    Japan

    Active - Recruiting

  • Local Institution - 0041

    Kitakyushu-shi, Fukuoka 806-8501
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 0608648
    Japan

    Active - Recruiting

  • Local Institution - 0036

    Sapporo, Hokkaido 0608648
    Japan

    Site Not Available

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyogo 660-8550
    Japan

    Active - Recruiting

  • Local Institution - 0032

    Amagasaki, Hyogo 660-8550
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Local Institution - 0033

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Local Institution - 0004

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Local Institution - 0013

    Yokosuka, Kanagawa 238-8558
    Japan

    Site Not Available

  • Yokosukakyosai

    Yokosuka, Kanagawa 238-8558
    Japan

    Active - Recruiting

  • Local Institution - 0001

    Sendai-shi, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Local Institution - 0028

    Sasebo, Nagasaki 857-8511
    Japan

    Site Not Available

  • Sasebo City General Hospital

    Sasebo, Nagasaki 857-8511
    Japan

    Active - Recruiting

  • Local Institution - 0019

    Ōmura, Nagasaki 856-8562
    Japan

    Site Not Available

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, Nagasaki 856-8562
    Japan

    Active - Recruiting

  • Kindai University Hospital- Osakasayama Campus

    Osaka-sayama, Osaka 589-8511
    Japan

    Active - Recruiting

  • Local Institution - 0009

    Hidaka, Saitama 350-1298
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Hidaka, Saitama 350-1298
    Japan

    Active - Recruiting

  • Local Institution - 0003

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • Local Institution - 0029

    Itabashiku, Tokyo 173-8610
    Japan

    Site Not Available

  • Nihon University Itabashi Hospital

    Itabashiku, Tokyo 173-8610
    Japan

    Active - Recruiting

  • Japanese Foundation for Cancer Research

    Koto, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Local Institution - 0040

    Koto, Tokyo 135-8550
    Japan

    Site Not Available

  • The Jikei University Hospital

    Minato-ku, Tokyo 105-8471
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka, 814-0180
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • Local Institution - 0012

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Local Institution - 0018

    Fukuoka, 810-8563
    Japan

    Site Not Available

  • Local Institution - 0023

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563
    Japan

    Active - Recruiting

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-0052
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima, 7348551
    Japan

    Active - Recruiting

  • Local Institution - 0025

    Hiroshima, 734-8551
    Japan

    Site Not Available

  • Local Institution - 0039

    Hiroshima, 730-0052
    Japan

    Site Not Available

  • Imamura General Hospital

    Kagoshima, 890-0064
    Japan

    Active - Recruiting

  • Local Institution - 0008

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • Local Institution - 0015

    Kagoshima, 890-0064
    Japan

    Site Not Available

  • Kumamoto University

    Kumamoto, 860-8556
    Japan

    Active - Recruiting

  • Local Institution - 0006

    Kumamoto, 860-8556
    Japan

    Active - Recruiting

  • Local Institution - 0035

    Kumamoto, 860-0008
    Japan

    Site Not Available

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008
    Japan

    Active - Recruiting

  • Local Institution - 0027

    Kyoto, 602-8566
    Japan

    Site Not Available

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Kyorin University Hospital

    Mitaka, 181-8611
    Japan

    Active - Recruiting

  • Local Institution - 0022

    Mitaka, 181-8611
    Japan

    Site Not Available

  • Local Institution - 0038

    Miyazaki, 889-1692
    Japan

    Site Not Available

  • University of Miyazaki Hospital

    Miyazaki, 889-1692
    Japan

    Active - Recruiting

  • Local Institution - 0030

    Nagasaki, 852-8104
    Japan

    Site Not Available

  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8104
    Japan

    Active - Recruiting

  • Local Institution - 0020

    Oita, 870-8511
    Japan

    Site Not Available

  • Oita Prefectural Hospital

    Oita, 870-8511
    Japan

    Active - Recruiting

  • Local Institution - 0007

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Local Institution - 0042

    Okinawa, 904-2195
    Japan

    Site Not Available

  • Nakagami Hospital Okinawa

    Okinawa, 904-2195
    Japan

    Active - Recruiting

  • Local Institution - 0010

    Osaka, 541-8567
    Japan

    Site Not Available

  • Local Institution - 0034

    Osaka, 545-8586
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • Local Institution - 0026

    Tokyo, 105-8461
    Japan

    Site Not Available

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