Brief Summary

The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

120

participants targeted

Target at P75+ for phase_1

Timeline

31mo left

Started Dec 2024

Longer than P75 for phase_1

Geographic Reach

13 countries

28 active sites

Status

enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress35%

Dec 2024Oct 2028

Study Start

First participant enrolled

December 30, 2024

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2028

Expected

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

January 16, 2025

Last Update Submit

April 9, 2026

Conditions

Leukemia, Myeloid, Acute Lymphoma, Non-Hodgkin Myelodysplastic Syndromes Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Solid Tumor, Adult Prostatic Neoplasms, Castration-Resistant

Outcome Measures

Primary Outcomes (1)

Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.
Up to approximately 3 years and 7 months

Study Arms (1)

Long Term Safety Assessment (Platform Study)

OTHER

The platform rollover study provides continued long-term access to study treatment(s) (JNJ-64264681; JNJ-67856633 (safimaltib); JNJ-54179060 (ibrutinib); JNJ-75348780; JNJ-74856665; JNJ-64619178; JNJ-70218902; JNJ-80948543; JNJ-87801493) for participants currently receiving the active study treatment in parent studies and deriving benefit from it. Eligible participants in parent study will rollover to this platform study which will be adapted into Intervention Specific Appendix (ISA) within the platform study. Participants will initiate the platform study under the relevant ISA, and will continue to receive study treatment at the dose they received in parent study.

Drug: JNJ-75348780Drug: JNJ-67856633Drug: JNJ-54179060Drug: JNJ-64264681Drug: JNJ-74856665Drug: JNJ-70218902Drug: JNJ-64619178Drug: JNJ-80948543Drug: JNJ-87801493

Interventions

JNJ-74856665DRUG

Participants from the parent study (74856665AML1001 \[NCT04609826\]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally.