search
Back to results

A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

Primary Purpose

Leukemia, Myeloid, Acute

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-75276617
Venetoclax (VEN)
Azacitidine (AZA)
Cytarabine
Daunorubicin or Idarubicin
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of AML according to World Health Organization (WHO) 2016 criteria a) De novo or secondary AML; b) relapsed /refractory (Arm A); c) harboring NPM1 / KMT2A alterations
  • Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function
  • ECOG performance status grade of 0, 1 or 2
  • A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
  • Must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study.
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Acute promyelocytic leukemia according to WHO 2016 criteria
  • Leukemic involvement of the central nervous system
  • Recipient of solid organ transplant
  • Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment (uncomplicated Grade less than or equal to [≤]2 deep vein thrombosis is not considered exclusionary);(g)Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
  • Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
  • Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation

Sites / Locations

  • The University of Alabama at BirminghamRecruiting
  • City of HopeRecruiting
  • Massachusetts General HospitalRecruiting
  • Albert Einstein College Of MedicineRecruiting
  • Novant HealthRecruiting
  • Novant Health Forsyth Medical CenterRecruiting
  • MD AndersonRecruiting
  • Monash Medical CentreRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • Westmead HospitalRecruiting
  • Institut Paoli CalmettesRecruiting
  • Institut Universitaire du Cancer Toulouse OncopoleRecruiting
  • CHU de Tours - Hôpital de BretonneauRecruiting
  • Charité Universitätsmedizin BerlinRecruiting
  • Universitätsklinikum Carl Gustav Carus DresdenRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • Universitaetsklinikum LeipzigRecruiting
  • Universitatsklinikum UlmRecruiting
  • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di BolognaRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • IRCCS Istituto Clinico HumanitasRecruiting
  • Hosp. de La Santa Creu I Sant PauRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Hosp. Univ. Fund. Jimenez DiazRecruiting
  • Clinica Univ. de NavarraRecruiting
  • University College London Hospitals NHSFTRecruiting
  • Christie Hospital NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A: Relapsed/Refractory Setting

Arm B: Newly Diagnosed Chemotherapy Ineligible Setting

Arm C: Newly Diagnosed Chemotherapy Eligible Setting

Arm Description

Participants with relapsed/refractory AML harboring either NPM1 or KMT2A alterations will receive JNJ-75276617 in combination with either venetoclax (VEN) (Cohort A1: JNJ75276617+VEN) or azacitidine (AZA) (Cohort A2: JNJ-75276617+AZA) or VEN+AZA (Cohort A3: JNJ-75276617+VEN+AZA) to select the recommended phase 2 dose (RP2D) of JNJ-75276617 in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive JNJ-75276617 in combination with AML directed therapies at the RP2D(s).

Participants will receive JNJ-75276617 in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring either KMT2A or NPM1 alterations who are greater than or equal to (>=) 75 years of age or >=18 to less than (<) 75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.

Participants will receive combination of JNJ-75276617 with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants >=18 to <75 years of age with AML harboring either NPM1 or KMT2A alterations and eligible for intensive chemotherapy.

Outcomes

Primary Outcome Measures

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.
Number of Participants with Adverse Events (AEs) by Severity
Number of Participants with AEs by severity will be reported. 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)
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined per protocol as any of the following: non-hematologic toxicity, or hematologic toxicity.

Secondary Outcome Measures

Plasma Concentration of JNJ- 75276617
Plasma samples will be analyzed to determine concentrations of JNJ-75276617 using a validated, specific, and sensitive method.
Number of Participants with Depletion of Leukemic Blasts
Number of participants with depletion of leukemic blasts will be reported.
Number of Participants with Differentiation of Leukemic Blasts
Number of participants with differentiation of leukemic blasts will be reported.
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes
Changes in expression of menin-KMT2A target genes will be reported.
Percentage of Participants who Achieve Complete Remission (CR)
Percentage of participants who achieve complete Remission (CR) will be reported. CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts and blasts with Auer rods; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0 x 109/Liter (1,000/microliter [μL] ); Platelet count >= 100 x 109/L (100,000/μL).
Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh)
Percentage of participants who achieve complete remission with partial hematologic recovery (CRh) will be reported. CRh is defined as All criteria of CR with both ANC >0.5 x 109/L (500/μL) and platelet count >50 x 109/L (50,000/μL).
Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
Percentage of participants who achieve complete remission with incomplete hematologic recovery (CRi) will be reported. CRi is defined as All CR criteria except for residual neutropenia (<1.0 x 109/L [1,000/μL]) or thrombocytopenia (<100 x 109/L [100,000/μL]).
Percentage of Participants who Achieved Overall Response
Percentage of participants who achieve overall response will be reported. Overall response rate (ORR) is defined as the percentage of participants achieving CR, CRh, or CRi.
Duration of response
Duration of response is defined as time from achieving first response of CR, CRh, CRi or overall response to hematologic relapse or death of any cause.
Time to Response
Time to response is defined as time from first dose to achieving the first response of CR, CRh, CRi or overall response.

Full Information

First Posted
July 8, 2022
Last Updated
September 12, 2023
Sponsor
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05453903
Brief Title
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
Official Title
A Phase 1b Study of JNJ-75276617 in Combination With AML Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
January 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).
Detailed Description
AML is a heterogenous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells (myeloid blasts) in the peripheral blood, bone marrow and other tissues and is the most common type of acute leukemia in adults. JNJ-75276617 is an orally bioavailable, potent, and selective protein-protein interaction inhibitor of the binding between histone-lysine N-methyltransferase 2A ([KMT2A], also called mixed-lineage leukemia 1 [MLL1]; wild-type and fusion) and menin, with activity in leukemic cell lines and primary leukemia patient or patient-derived samples with either KMT2A alterations including gene rearrangements (KMT2A-r), duplications, and amplification, or nucleophosmin 1 gene (NPM1) alterations. The aim of this study is to determine the RP2D(s), safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity of JNJ-75276617 in combination with AML directed therapies for adult participants with relapsed/refractory or newly diagnosed AML with NPM1 or KMT2A gene alterations and will include dose selection and subsequent combination specific dose expansion. The total study duration will be up to 2 years. Safety evaluations include adverse events (AE) monitoring, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements, physical examination findings, and eastern cooperative oncology group (ECOG) performance status score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Relapsed/Refractory Setting
Arm Type
Experimental
Arm Description
Participants with relapsed/refractory AML harboring either NPM1 or KMT2A alterations will receive JNJ-75276617 in combination with either venetoclax (VEN) (Cohort A1: JNJ75276617+VEN) or azacitidine (AZA) (Cohort A2: JNJ-75276617+AZA) or VEN+AZA (Cohort A3: JNJ-75276617+VEN+AZA) to select the recommended phase 2 dose (RP2D) of JNJ-75276617 in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive JNJ-75276617 in combination with AML directed therapies at the RP2D(s).
Arm Title
Arm B: Newly Diagnosed Chemotherapy Ineligible Setting
Arm Type
Experimental
Arm Description
Participants will receive JNJ-75276617 in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring either KMT2A or NPM1 alterations who are greater than or equal to (>=) 75 years of age or >=18 to less than (<) 75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.
Arm Title
Arm C: Newly Diagnosed Chemotherapy Eligible Setting
Arm Type
Experimental
Arm Description
Participants will receive combination of JNJ-75276617 with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants >=18 to <75 years of age with AML harboring either NPM1 or KMT2A alterations and eligible for intensive chemotherapy.
Intervention Type
Drug
Intervention Name(s)
JNJ-75276617
Intervention Description
Participants will receive JNJ-75276617.
Intervention Type
Drug
Intervention Name(s)
Venetoclax (VEN)
Intervention Description
Participants will receive VEN.
Intervention Type
Drug
Intervention Name(s)
Azacitidine (AZA)
Intervention Description
Participants will receive AZA.
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Participants will receive cytarabine
Intervention Type
Drug
Intervention Name(s)
Daunorubicin or Idarubicin
Intervention Description
Participants will receive daunorubicin or idarubicin
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
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.
Time Frame
Up to 2 Years
Title
Number of Participants with Adverse Events (AEs) by Severity
Description
Number of Participants with AEs by severity will be reported. 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.
Time Frame
Up to 2 Years
Title
Number of Participants with Dose-limiting Toxicity (DLT)
Description
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined per protocol as any of the following: non-hematologic toxicity, or hematologic toxicity.
Time Frame
End of Cycle 1 (28 days)
Secondary Outcome Measure Information:
Title
Plasma Concentration of JNJ- 75276617
Description
Plasma samples will be analyzed to determine concentrations of JNJ-75276617 using a validated, specific, and sensitive method.
Time Frame
Up to 2 Years
Title
Number of Participants with Depletion of Leukemic Blasts
Description
Number of participants with depletion of leukemic blasts will be reported.
Time Frame
Up to 2 Years
Title
Number of Participants with Differentiation of Leukemic Blasts
Description
Number of participants with differentiation of leukemic blasts will be reported.
Time Frame
Up to 2 Years
Title
Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes
Description
Changes in expression of menin-KMT2A target genes will be reported.
Time Frame
Up to 2 Years
Title
Percentage of Participants who Achieve Complete Remission (CR)
Description
Percentage of participants who achieve complete Remission (CR) will be reported. CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts and blasts with Auer rods; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0 x 109/Liter (1,000/microliter [μL] ); Platelet count >= 100 x 109/L (100,000/μL).
Time Frame
Up to 2 Years
Title
Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh)
Description
Percentage of participants who achieve complete remission with partial hematologic recovery (CRh) will be reported. CRh is defined as All criteria of CR with both ANC >0.5 x 109/L (500/μL) and platelet count >50 x 109/L (50,000/μL).
Time Frame
Up to 2 Years
Title
Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
Description
Percentage of participants who achieve complete remission with incomplete hematologic recovery (CRi) will be reported. CRi is defined as All CR criteria except for residual neutropenia (<1.0 x 109/L [1,000/μL]) or thrombocytopenia (<100 x 109/L [100,000/μL]).
Time Frame
Up to 2 years
Title
Percentage of Participants who Achieved Overall Response
Description
Percentage of participants who achieve overall response will be reported. Overall response rate (ORR) is defined as the percentage of participants achieving CR, CRh, or CRi.
Time Frame
Up to 2 Years
Title
Duration of response
Description
Duration of response is defined as time from achieving first response of CR, CRh, CRi or overall response to hematologic relapse or death of any cause.
Time Frame
Up to 2 Years
Title
Time to Response
Description
Time to response is defined as time from first dose to achieving the first response of CR, CRh, CRi or overall response.
Time Frame
Up to 2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of AML according to World Health Organization (WHO) 2016 criteria a) De novo or secondary AML; b) relapsed /refractory (Arm A); c) harboring NPM1 / KMT2A alterations Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function ECOG performance status grade of 0, 1 or 2 A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment Must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study. Willing and able to adhere to the prohibitions and restrictions specified in this protocol Exclusion Criteria: Acute promyelocytic leukemia according to WHO 2016 criteria Leukemic involvement of the central nervous system Recipient of solid organ transplant Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment (uncomplicated Grade less than or equal to [≤]2 deep vein thrombosis is not considered exclusionary);(g)Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia) Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Albert Einstein College Of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du Cancer Toulouse Oncopole
City
Toulouse Cedex 9
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Tours - Hôpital de Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHSFT
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

We'll reach out to this number within 24 hrs