Leukemia, Myeloid, AcutePhase 1NCT06788509
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
A Phase 1 study testing JNJ-75348780, JNJ-67856633 and JNJ-54179060 in people with Leukemia, Myeloid, Acute and Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 39 sites in 15 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
- What is being tested?
- JNJ-75348780, JNJ-67856633 and JNJ-54179060
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 39 sitesin 15 countries
- Study dates
- 30 Dec 2024to 29 Dec 2028
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 15 countries
Spain7 sites
Hosp Univ Vall D Hebron 1
Barcelona, 08035
Hosp Univ Vall D Hebron
Barcelona, 08035
Hosp. Clinic de Barcelona
Barcelona, 08036
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Hosp. Univ. 12 de Octubre
Madrid, 28041
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Israel5 sites
Rambam Med.Center - Hematology Institute
Haifa, 3109601
Rambam Medical Center
Haifa, 3109601
Carmel Medical Center
Haifa, 3436212
Hadassah University Hospita Ein Kerem
Jerusalem, 9112001
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Australia4 sites
Macquarie University Hospital
Macquarie University, 2109
The Alfred Hospital
Melbourne, 3004
Linear Clinical Research Ltd
Nedlands, 6009
Scientia Clinical Research
Randwick, 2031
Taiwan4 sites
Chang Kung Memorial Hospital
Kaohsiung City, 833
China Medical University Hospital
Taichung, 404327
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
France3 sites
Hopital Claude Huriez
Lille, 59000
CHU Nantes
Nantes, 44093
Institut Gustave Roussy
Villejuif, 94805
Poland3 sites
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, 80 214
Pratia MCM Krakow
Krakow, 30-727
Aidport Sp z o o
Skorzewo, 60-185
United Kingdom3 sites
University Hospitals Of Leicester Nhs Trust
Leicester, Le1 5ww
St Bartholomews Hospital
London, EC1A 7BE
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
Denmark2 sites
Dep. of Hematology, Rigshospitalet
Copenhagen, 2100
Odense Universitetshospital
Odense C, DK-5000
Japan2 sites
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550
South Korea1 site
Severance Hospital Yonsei University Health System
Seoul, 03722
Ukraine1 site
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv, 01135
About this study
Official title: An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring
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).
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Neoplasms, Solid Tumor, Adult
- Being tested
- JNJ-75348780, JNJ-67856633, JNJ-54179060, JNJ-64264681, JNJ-74856665
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Neoplasms, Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-75348780Drug
Participants from the parent study (75348780LYM1001 [NCT04540796]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780.
JNJ-67856633Drug
Also called safimaltib
Participants from the parent studies (64264681LYM1002 [NCT04657224], 67856633LYM1002 [NCT04876092] and 67856633LYM1001 [NCT03900598]) who are deriving benefit from study treatment will continue to receive JNJ-67856633 orally.
JNJ-54179060Drug
Also called ibrutinib
Participants from the parent study (67856633LYM1002 [NCT04876092]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally.
JNJ-64264681Drug
Participants from the parent studies (64264681LYM1001 [NCT04210219], 64264681LYM1002 [NCT04657224]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally.
JNJ-74856665Drug
Participants from the parent study (74856665AML1001 [NCT04609826]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally.
JNJ-70218902Drug
Participants from the parent study (70218902EDI1001 [NCT04397276]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally.
JNJ-64619178Drug
Participants from the parent study (64619178EDI1001 [NCT03573310]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally.
JNJ-80948543Drug
Participants from the parent studies (80948543LYM1001 [NCT05424822]; and 80948543LYM1002 [NCT06660563]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543.
JNJ-87801493Drug
Participants from the parent study (87801493LYM1001 [NCT06139406]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-87801493 in combination with subcutaneous JNJ-80948543.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JNJ-75348780; Drug: JNJ-67856633; Drug: JNJ-54179060; Drug: JNJ-64264681; Drug: JNJ-74856665; Drug: JNJ-70218902; Drug: JNJ-64619178; Drug: JNJ-80948543; Drug: JNJ-87801493 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 3 years and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start30 Dec 2024
- Primary completion19 Jan 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research and Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788509
- Sponsor's protocol ID
- PLATFORMPACAN1001
- Other IDs
- PLATFORMPACAN1001, 2024-515457-21-00
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring
- ClinicalTrials.gov ID
- NCT06788509
- Acronym / sponsor ID
- PLATFORMPACAN1001
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Neoplasms, Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 19 Jan 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long Term Safety Assessment (Platform Study) | Other | Drug: JNJ-75348780, Drug: JNJ-67856633, Drug: JNJ-54179060, Drug: JNJ-64264681, Drug: JNJ-74856665, Drug: JNJ-70218902, Drug: JNJ-64619178, Drug: JNJ-80948543, Drug: JNJ-87801493The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-75348780Participants from the parent study (75348780LYM1001 [NCT04540796]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-67856633Also: safimaltibParticipants from the parent studies (64264681LYM1002 [NCT04657224], 67856633LYM1002 [NCT04876092] and 67856633LYM1001 [NCT03900598]) who are deriving benefit from study treatment will continue to receive JNJ-67856633 orally. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-54179060Also: ibrutinibParticipants from the parent study (67856633LYM1002 [NCT04876092]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-64264681Participants from the parent studies (64264681LYM1001 [NCT04210219], 64264681LYM1002 [NCT04657224]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-74856665Participants from the parent study (74856665AML1001 [NCT04609826]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-70218902Participants from the parent study (70218902EDI1001 [NCT04397276]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-64619178Participants from the parent study (64619178EDI1001 [NCT03573310]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-80948543Participants from the parent studies (80948543LYM1001 [NCT05424822]; and 80948543LYM1002 [NCT06660563]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543. | Drug | Long Term Safety Assessment (Platform Study) |
| JNJ-87801493Participants from the parent study (87801493LYM1001 [NCT06139406]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-87801493 in combination with subcutaneous JNJ-80948543. | Drug | Long Term Safety Assessment (Platform Study) |
Primary outcome
Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)
Time frame: Up to approximately 3 years and 7 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research and Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
39 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-75348780, JNJ-67856633 and JNJ-54179060 in people with Leukemia, Myeloid, Acute and Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 39 sites in 15 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain, Israel, Australia, Taiwan, France and 10 more countries. 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?
Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs) (time frame: Up to approximately 3 years and 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.