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A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias

  • 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).

Studies

Study First Submitted Date 2022-08-29
Study First Posted Date 2022-08-30
Last Update Posted Date 2023-07-20
Start Month Year February 7, 2024
Primary Completion Month Year September 11, 2026
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-20

Facilities

Sequence: 199716526 Sequence: 199716527 Sequence: 199716528 Sequence: 199716529 Sequence: 199716530 Sequence: 199716531 Sequence: 199716532 Sequence: 199716533 Sequence: 199716534 Sequence: 199716535 Sequence: 199716536 Sequence: 199716537 Sequence: 199716538 Sequence: 199716539 Sequence: 199716540 Sequence: 199716541 Sequence: 199716542 Sequence: 199716543 Sequence: 199716544 Sequence: 199716545 Sequence: 199716546 Sequence: 199716547 Sequence: 199716548 Sequence: 199716549 Sequence: 199716550 Sequence: 199716551 Sequence: 199716552 Sequence: 199716553 Sequence: 199716554 Sequence: 199716555 Sequence: 199716556
Name University of Alabama at Birmingham Name City of Hope National Medical Center Name Dana-Farber Cancer Institute Name Memorial Sloan Kettering Name UNC Hospitals – N.C. Childrens Hospital Name Atrium Health Name Cincinnati Children's Hospital Medical Center Name St Jude Children's Research Hospital Name MD Anderson Cancer Center Name University of Utah Name Children's Wisconsin – Milwaukee Hospital Name Hôpital Jeanne de Flandre Name Institut D'Hematologie Et D'Oncologie Pediatrique Name Hôpital trousseau- APHP Name Hôpital Robert Debré Name CHU de Rennes – Hôpital Sud Name CHU de Toulouse Hopital des Enfants Name Centre Hospitalier Universitaire de Nancy – Hôpital Central Name Charité – Universitätsmedizin Berlin, Campus Virchow Klinikum Name Universitatsklinikum Essen Name Universitaetsklinik Hamburg-Eppendorf Name Medizinische Hochschule Hannover Name Dr. Von Haunersches Kinderspital der Universitaet Muenchen Name Hosp. Univ. Vall D Hebron Name Hosp. Infantil Univ. Niño Jesus Name Hosp. Univ. Miguel Servet Name Birmingham Children's Hospital Name Royal Hospital for Sick Children Name University College London Hospitals Name Great Ormond Street Hospital Name Royal Marsden Hospital
City Birmingham City Duarte City Boston City New York City Chapel Hill City Charlotte City Cincinnati City Memphis City Houston City Salt Lake City City Milwaukee City Lille City Lyon Cedex 08 City Paris City Paris City Rennes Cedex 2 City Toulouse City Vandœuvre-lès-Nancy City Berlin City Essen City Hamburg City Hannover City Munchen City Barcelona City Madrid City Zaragoza City Birmingham City Glasgow City London City London City Sutton
State Alabama State California State Massachusetts State New York State North Carolina State North Carolina State Ohio State Tennessee State Texas State Utah State Wisconsin
Zip 35233 Zip 91010 Zip 02115 Zip 10065 Zip 27514 Zip 28203 Zip 45229 Zip 38105 Zip 77030 Zip 84112 Zip 53226 Zip 59000 Zip 69008 Zip 75012 Zip 75019 Zip 35200 Zip 31300 Zip 54500 Zip 12203 Zip 45147 Zip 20246 Zip 30625 Zip 80337 Zip 08035 Zip 28009 Zip 50009 Zip B4 6NH Zip G51 4TF Zip NW1 2PG Zip WC1N 3JH Zip SM2 5PT
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country France Country France Country France Country France Country France Country France Country France Country Germany Country Germany Country Germany Country Germany Country Germany Country Spain Country Spain Country Spain Country United Kingdom Country United Kingdom Country United Kingdom Country United Kingdom Country United Kingdom

Browse Interventions

Sequence: 95887469 Sequence: 95887470 Sequence: 95887471 Sequence: 95887472 Sequence: 95887473 Sequence: 95887474 Sequence: 95887475 Sequence: 95887476 Sequence: 95887477 Sequence: 95887478 Sequence: 95887479 Sequence: 95887480 Sequence: 95887481 Sequence: 95887482 Sequence: 95887483 Sequence: 95887484 Sequence: 95887485 Sequence: 95887486 Sequence: 95887487 Sequence: 95887488 Sequence: 95887489 Sequence: 95887490 Sequence: 95887491 Sequence: 95887492 Sequence: 95887493 Sequence: 95887494 Sequence: 95887495
Mesh Term Cytarabine Mesh Term Dexamethasone Mesh Term Fludarabine Mesh Term Vincristine Mesh Term Pegaspargase Mesh Term Anti-Inflammatory Agents Mesh Term Antiemetics Mesh Term Autonomic Agents Mesh Term Peripheral Nervous System Agents Mesh Term Physiological Effects of Drugs Mesh Term Gastrointestinal Agents Mesh Term Glucocorticoids Mesh Term Hormones Mesh Term Hormones, Hormone Substitutes, and Hormone Antagonists Mesh Term Antineoplastic Agents, Hormonal Mesh Term Antineoplastic Agents Mesh Term Antimetabolites, Antineoplastic Mesh Term Antimetabolites Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Immunosuppressive Agents Mesh Term Immunologic Factors Mesh Term Antiviral Agents Mesh Term Anti-Infective Agents Mesh Term Antineoplastic Agents, Phytogenic Mesh Term Tubulin Modulators Mesh Term Antimitotic Agents Mesh Term Mitosis Modulators
Downcase Mesh Term cytarabine Downcase Mesh Term dexamethasone Downcase Mesh Term fludarabine Downcase Mesh Term vincristine Downcase Mesh Term pegaspargase Downcase Mesh Term anti-inflammatory agents Downcase Mesh Term antiemetics Downcase Mesh Term autonomic agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term gastrointestinal agents Downcase Mesh Term glucocorticoids Downcase Mesh Term hormones Downcase Mesh Term hormones, hormone substitutes, and hormone antagonists Downcase Mesh Term antineoplastic agents, hormonal Downcase Mesh Term antineoplastic agents Downcase Mesh Term antimetabolites, antineoplastic Downcase Mesh Term antimetabolites Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term immunosuppressive agents Downcase Mesh Term immunologic factors Downcase Mesh Term antiviral agents Downcase Mesh Term anti-infective agents Downcase Mesh Term antineoplastic agents, phytogenic Downcase Mesh Term tubulin modulators Downcase Mesh Term antimitotic agents Downcase Mesh Term mitosis modulators
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52090375 Sequence: 52090376 Sequence: 52090377 Sequence: 52090378
Name Acute Leukemias Name Acute Myeloid Leukemia Name Acute Lymphoblastic Leukemia Name Acute Leukemia of Ambiguous Lineage
Downcase Name acute leukemias Downcase Name acute myeloid leukemia Downcase Name acute lymphoblastic leukemia Downcase Name acute leukemia of ambiguous lineage

Id Information

Sequence: 40094387 Sequence: 40094388 Sequence: 40094389
Id Source org_study_id Id Source secondary_id Id Source secondary_id
Id Value CR109192 Id Value 2022-000380-46 Id Value 75276617ALE1003
Id Type EudraCT Number Id Type Other Identifier
Id Type Description Janssen Research & Development, LLC

Countries

Sequence: 42494682 Sequence: 42494683 Sequence: 42494684 Sequence: 42494685 Sequence: 42494686
Name United States Name France Name Germany Name Spain Name United Kingdom
Removed False Removed False Removed False Removed False Removed False

Design Groups

Sequence: 55504831 Sequence: 55504832
Group Type Experimental Group Type Experimental
Title Arm A: <2 Years Old Title Arm B: >=2 Years Old
Description 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. Description 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.

Interventions

Sequence: 52403577 Sequence: 52403578 Sequence: 52403579 Sequence: 52403580 Sequence: 52403581 Sequence: 52403582 Sequence: 52403583
Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name JNJ-75276617 Name Fludarabine Name Cytarabine Name Intrathecal Chemotherapy Name Dexamethasone Name Vincristine Name Pegaspargase
Description JNJ-75276617 will be administered orally. Description Fludarabine chemotherapy will be administered as intravenous (IV) infusion for participants with AML. Description Cytarabine chemotherapy will be administered as IV infusion for participants with AML. Description Intrathecal chemotherapy will be administered as IV infusion for participants with AML or B-cell ALL. Description Dexamethasone chemotherapy will be administered as IV infusion for participants with B-cell ALL. Description Vincristine chemotherapy will be administered as IV infusion for participants with B-cell ALL. Description Pegaspargase chemotherapy will be administered as IV infusion for participants with B-cell ALL.

Design Outcomes

Sequence: 177100888 Sequence: 177100889 Sequence: 177100890 Sequence: 177100891 Sequence: 177100892 Sequence: 177100893 Sequence: 177100894 Sequence: 177100895 Sequence: 177100896 Sequence: 177100897 Sequence: 177100898 Sequence: 177100899
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Number of Participants with Adverse Events (AEs) Measure Number of Participants with AEs by Severity Measure Number of Participants with Dose-Limiting Toxicity (DLT) Measure Plasma Concentration of JNJ-75276617 Measure Number of Participants with Depletion of Leukemic Blasts Measure Number of Participants with Differentiation of Leukemic Blasts Measure Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes or Genes Associated With Differentiation Measure Overall Response Rate (ORR) per Response Criteria in Acute Myeloid Leukemia (AML) Measure Overall Response Rate (ORR) per the Response Criteria in B-cell Acute Lymphoblastic Leukemia (ALL) Measure Time to Response (TTR) Measure Duration of Response (DOR) Measure Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Cycle 1 (28 days) Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months Time Frame Up to 3 years 5 months
Description 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. Description 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. Description 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. Description Plasma concentration of JNJ-75276617 will be reported. Description Number of participants with depletion of leukemic blasts will be reported. Description Number of participants with differentiation of leukemic blasts will be reported. Description Changes in expression of menin-histone-lysine N-methyltransferase 2A (KMT2A) target genes or genes associated with differentiation will be reported. Description 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. Description 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. Description 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. Description 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. Description Percentage of participants who receive an allogeneic HSCT after treatment will be reported.

Browse Conditions

Sequence: 193166013 Sequence: 193166014 Sequence: 193166015 Sequence: 193166016 Sequence: 193166017 Sequence: 193166018 Sequence: 193166019 Sequence: 193166020 Sequence: 193166021 Sequence: 193166022 Sequence: 193166023 Sequence: 193166024
Mesh Term Leukemia Mesh Term Precursor Cell Lymphoblastic Leukemia-Lymphoma Mesh Term Acute Disease Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Leukemia, Lymphoid Mesh Term Lymphoproliferative Disorders Mesh Term Lymphatic Diseases Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term leukemia Downcase Mesh Term precursor cell lymphoblastic leukemia-lymphoma Downcase Mesh Term acute disease Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term leukemia, lymphoid Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term lymphatic diseases Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48244747
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Janssen Research & Development, LLC

Overall Officials

Sequence: 29238532
Role Study Director
Name Janssen Research & Development, LLC Clinical Trial
Affiliation Janssen Research & Development, LLC

Central Contacts

Sequence: 11991833
Contact Type primary
Name Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Role Contact

Design Group Interventions

Sequence: 68041128 Sequence: 68041129 Sequence: 68041130 Sequence: 68041131 Sequence: 68041132 Sequence: 68041133 Sequence: 68041134 Sequence: 68041135 Sequence: 68041136 Sequence: 68041137 Sequence: 68041138 Sequence: 68041139 Sequence: 68041140 Sequence: 68041141
Design Group Id 55504831 Design Group Id 55504832 Design Group Id 55504831 Design Group Id 55504832 Design Group Id 55504831 Design Group Id 55504832 Design Group Id 55504831 Design Group Id 55504832 Design Group Id 55504831 Design Group Id 55504832 Design Group Id 55504831 Design Group Id 55504832 Design Group Id 55504831 Design Group Id 55504832
Intervention Id 52403577 Intervention Id 52403577 Intervention Id 52403578 Intervention Id 52403578 Intervention Id 52403579 Intervention Id 52403579 Intervention Id 52403580 Intervention Id 52403580 Intervention Id 52403581 Intervention Id 52403581 Intervention Id 52403582 Intervention Id 52403582 Intervention Id 52403583 Intervention Id 52403583

Eligibilities

Sequence: 30718648
Gender All
Minimum Age 30 Days
Maximum Age 30 Years
Healthy Volunteers No
Criteria Inclusion Criteria: 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 Exclusion Criteria: 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)
Adult True
Child True
Older Adult False

Calculated Values

Sequence: 253956592
Number Of Facilities 31
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 30
Maximum Age Num 30
Minimum Age Unit Days
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 9

Designs

Sequence: 30465166
Allocation Non-Randomized
Intervention Model Sequential Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28831620
Responsible Party Type Sponsor
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