Acute LeukemiasPhase 1NCT05521087
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias
A Phase 1 study testing JNJ-75276617, Fludarabine and Cytarabine in people with Acute Leukemias and Acute Myeloid Leukemia, run by Janssen Research & Development, LLC.
Trial summary
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene… Read more about this study
- Who is it for?
- Ages 30 days to 30 years
- Conditions the study is for
- Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- JNJ-75276617, Fludarabine and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2025to 29 Jan 2030
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 30 days to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations
- Performance status greater than or equal to (>=) 50 by lansky scale (for participants less than [<] 16 years of age) or >=50 percent (%) karnofsky scale (for participants >=16 years of age)
- Estimated or measured glomerular filtration rate >= 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) based on the bed side schwartz formula
Who cannot join
- Received an allogeneic hematopoietic transplant within 60 days of screening
- Active acute graft-versus-host disease of any grade or chronic graft-versus-host which is not well-controlled
- Received immunosuppressive therapy post hematopoietic transplant within 30 days of enrollment
- Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile myelomonocytic leukemia
- Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any other known bone marrow failure syndrome
- Prior exposure to menin-KMT2A inhibitors
- Prior cancer immunotherapy (ie [that is], Chimeric Antigen Receptor-T Cell Therapy [CAR-T], inotuzumab, gemtuzumab ozogamicin) within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
About this study
Official title: A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).
- Conditions
- Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Leukemia of Ambiguous Lineage
- Being tested
- JNJ-75276617, Fludarabine, Cytarabine, Intrathecal Chemotherapy, Dexamethasone
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-75276617Drug
JNJ-75276617 will be administered orally.
FludarabineDrug
Fludarabine chemotherapy will be administered as intravenous (IV) infusion for participants with AML.
CytarabineDrug
Cytarabine chemotherapy will be administered as IV infusion for participants with AML.
Intrathecal ChemotherapyDrug
Intrathecal chemotherapy will be administered as IV infusion for participants with AML or B-cell ALL.
DexamethasoneDrug
Dexamethasone chemotherapy will be administered as IV infusion for participants with B-cell ALL.
VincristineDrug
Vincristine chemotherapy will be administered as IV infusion for participants with B-cell ALL.
PegaspargaseDrug
Pegaspargase chemotherapy will be administered as IV infusion for participants with B-cell ALL.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: <2 Years Old | Experimental | Participants aged less than (<) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by study evaluation team (SET) until the recommended Phase 2 Doses (RP2Ds) has been identified. Participants in dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion of the study, in 3 cohorts divided on the basis of disease diagnosis. Participants with acute myeloid leukemia (AML) and B-cell acute lymphoblastic leukemia (ALL) will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617. Receives: Drug: JNJ-75276617; Drug: Fludarabine; Drug: Cytarabine; Drug: Intrathecal Chemotherapy; Drug: Dexamethasone; Drug: Vincristine; Drug: Pegaspargase |
| Arm B: >=2 Years Old | Experimental | Participants aged greater than or equal to (>=) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further dose levels will be escalated based on the DLT evaluation by SET until the RP2Ds has been identified. Participants in dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion, in 3 cohorts divided on the basis of disease diagnosis. Participants with AML and B-cell ALL will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617. Receives: Drug: JNJ-75276617; Drug: Fludarabine; Drug: Cytarabine; Drug: Intrathecal Chemotherapy; Drug: Dexamethasone; Drug: Vincristine; Drug: Pegaspargase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 3 years 5 months
Number of Participants with AEs by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Measured: Up to 3 years 5 months
Number of Participants with Dose-Limiting Toxicity (DLT)
Percentage of participants with DLT will be assessed. The DLTs are specific adverse events related to JNJ-75276617 and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Measured: Cycle 1 (28 days)
Secondary outcomes (9)
Plasma Concentration of JNJ-75276617
Plasma concentration of JNJ-75276617 will be reported.
Measured: Up to 3 years 5 months
Number of Participants with Depletion of Leukemic Blasts
Number of participants with depletion of leukemic blasts will be reported.
Measured: Up to 3 years 5 months
Number of Participants with Differentiation of Leukemic Blasts
Number of participants with differentiation of leukemic blasts will be reported.
Measured: Up to 3 years 5 months
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes or Genes Associated With Differentiation
Changes in expression of menin-histone-lysine N-methyltransferase 2A (KMT2A) target genes or genes associated with differentiation will be reported.
Measured: Up to 3 years 5 months
Overall Response Rate (ORR) per Response Criteria in Acute Myeloid Leukemia (AML)
ORR is defined as the percentage of participants who achieve complete response (CR), CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh) per the Response Criteria in AML.
Measured: Up to 3 years 5 months
Overall Response Rate (ORR) per the Response Criteria in B-cell Acute Lymphoblastic Leukemia (ALL)
ORR in participants with B-cell ALL is defined as the percentage of participants who achieve CR or CRi per the response criteria in B-cell ALL.
Measured: Up to 3 years 5 months
Time to Response (TTR)
TTR is defined for the responders as the time from the date of the first dose of JNJ-75276617 to the date of the first documented response.
Measured: Up to 3 years 5 months
Duration of Response (DOR)
DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first.
Measured: Up to 3 years 5 months
Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Percentage of participants who receive an allogeneic HSCT after treatment will be reported.
Measured: Up to 3 years 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start26 Dec 2025 (estimated)
- Primary completion11 Sep 2026 (estimated)
- Study completion29 Jan 2030 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiasStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521087
- Sponsor's protocol ID
- CR109192
- Other IDs
- 75276617ALE1003, 2022-000380-46
- Status last verified
- Jun 2025
- First submitted
- 29 Aug 2022
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
- ClinicalTrials.gov ID
- NCT05521087
- Acronym / sponsor ID
- CR109192
- Conditions
- Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Leukemia of Ambiguous Lineage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2025 (estimated)
- Primary completion
- 11 Sep 2026 (estimated)
- Study completion
- 29 Jan 2030 (estimated)
- First posted
- 30 Aug 2022 (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 determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: <2 Years Old | Experimental | Drug: JNJ-75276617, Drug: Fludarabine, Drug: Cytarabine, Drug: Intrathecal Chemotherapy, Drug: Dexamethasone, Drug: Vincristine, Drug: PegaspargaseParticipants aged less than (<) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by study evaluation team (SET) until the recommended Phase 2 Doses (RP2Ds) has been identified. Participants in dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion of the study, in 3 cohorts divided on the basis of disease diagnosis. Participants with acute myeloid leukemia (AML) and B-cell acute lymphoblastic leukemia (ALL) will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617. |
| Arm B: >=2 Years Old | Experimental | Drug: JNJ-75276617, Drug: Fludarabine, Drug: Cytarabine, Drug: Intrathecal Chemotherapy, Drug: Dexamethasone, Drug: Vincristine, Drug: PegaspargaseParticipants aged greater than or equal to (>=) 2 years old in dose escalation portion of the study will receive JNJ-75276617 orally on a 28-day cycle. Starting dose of JNJ-75276617 is based on the adult dose from the ongoing study NCT04811560 with additional dose reductions based on age. Further dose levels will be escalated based on the DLT evaluation by SET until the RP2Ds has been identified. Participants in dose expansion portion of the study will receive JNJ-75276617 orally at one of the RP2D(s) determined in dose escalation portion, in 3 cohorts divided on the basis of disease diagnosis. Participants with AML and B-cell ALL will receive conventional chemotherapy backbone regimen (dexamethasone, vincristine, pegaspargase, fludarabine, cytarabine and intrathecal chemotherapy) in combination with JNJ-75276617. |
Who may qualify
- Ages
- 30 days to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations
- Performance status greater than or equal to (>=) 50 by lansky scale (for participants less than [<] 16 years of age) or >=50 percent (%) karnofsky scale (for participants >=16 years of age)
- Estimated or measured glomerular filtration rate >= 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) based on the bed side schwartz formula
Key exclusion criteria (7 listed)
- Received an allogeneic hematopoietic transplant within 60 days of screening
- Active acute graft-versus-host disease of any grade or chronic graft-versus-host which is not well-controlled
- Received immunosuppressive therapy post hematopoietic transplant within 30 days of enrollment
- Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile myelomonocytic leukemia
- Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any other known bone marrow failure syndrome
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-75276617JNJ-75276617 will be administered orally. | Drug | Arm A: <2 Years Old, Arm B: >=2 Years Old |
| FludarabineFludarabine chemotherapy will be administered as intravenous (IV) infusion for participants with AML. | Drug | Arm A: <2 Years Old, Arm B: >=2 Years Old |
| CytarabineCytarabine chemotherapy will be administered as IV infusion for participants with AML. | Drug | Arm A: <2 Years Old, Arm B: >=2 Years Old |
| Intrathecal ChemotherapyIntrathecal chemotherapy will be administered as IV infusion for participants with AML or B-cell ALL. | Drug | Arm A: <2 Years Old, Arm B: >=2 Years Old |
| DexamethasoneDexamethasone chemotherapy will be administered as IV infusion for participants with B-cell ALL. | Drug | Arm A: <2 Years Old, Arm B: >=2 Years Old |
| VincristineVincristine chemotherapy will be administered as IV infusion for participants with B-cell ALL. | Drug | Arm A: <2 Years Old, Arm B: >=2 Years Old |
| PegaspargasePegaspargase chemotherapy will be administered as IV infusion for participants with B-cell ALL. | Drug | Arm A: <2 Years Old, Arm B: >=2 Years Old |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 3 years 5 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with AEs by Severity
Time frame: Up to 3 years 5 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Number of Participants with Dose-Limiting Toxicity (DLT)
Time frame: Cycle 1 (28 days)
Percentage of participants with DLT will be assessed. The DLTs are specific adverse events related to JNJ-75276617 and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
9 secondary outcomes
Plasma Concentration of JNJ-75276617
Time frame: Up to 3 years 5 months
Number of Participants with Depletion of Leukemic Blasts
Time frame: Up to 3 years 5 months
Number of Participants with Differentiation of Leukemic Blasts
Time frame: Up to 3 years 5 months
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes or Genes Associated With Differentiation
Time frame: Up to 3 years 5 months
Overall Response Rate (ORR) per Response Criteria in Acute Myeloid Leukemia (AML)
Time frame: Up to 3 years 5 months
Overall Response Rate (ORR) per the Response Criteria in B-cell Acute Lymphoblastic Leukemia (ALL)
Time frame: Up to 3 years 5 months
Time to Response (TTR)
Time frame: Up to 3 years 5 months
Duration of Response (DOR)
Time frame: Up to 3 years 5 months
Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Time frame: Up to 3 years 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-75276617, Fludarabine and Cytarabine in people with Acute Leukemias and Acute Myeloid Leukemia, run by Janssen Research & Development, LLC.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 Adverse Events (AEs) (time frame: Up to 3 years 5 months). The study lists 3 primary outcomes in all. 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 22 Jun 2025.