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Protocol NumberPLATFORMPACAN1001
NCT Number(ClinicalTrials.gov Identfier)NCT06788509
Active

2025-03-01 - 2028-04-30

Phase I

Recruiting4

An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Shang-Ju Wu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王銘崇 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Leukemia, Myeloid, Acute

Objectives

The purpose of this platform-based trial is to provide ongoing treatment to participants in the "parent trial" that has completed its primary clinical study report (CSR), ensuring: • continued access to the experimental treatment for participants who are currently receiving and benefiting from it, and • continued parent trial-specific safety monitoring. The current "parent trial" is being incorporated into the Intervention Specific Appendix (ISA) of this platform trial. ISA 2 is a long-term extension of the Intervention Specific Appendix – 64264681LYM1001 of the primary trial plan PLATFORMPACAN1001. ISA 5 is a long-term extension of the Intervention Specific Appendix – 75348780LYM1001 of the primary trial plan PLATFORMPACAN1001.

Test Drug

皮下注射劑
膠囊劑

Active Ingredient

JNJ-75348780
JNJ-64264681

Dosage Form

220
130

Dosage

NA

Endpoints

Number of participants who experienced a serious adverse event (SAE) or a related adverse event (AE) of grade 3 or higher.

Inclution Criteria

Inclusion Criteria:

Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study
Satisfy all ISA specific inclusion criteria
Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA
Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA

Exclusion Criteria

Exclusion Criteria:

Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA
Meets any exclusion criteria within the pertinent ISA

The Estimated Number of Participants

  • Taiwan

    11 participants

  • Global

    72 participants

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