To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
NCT ID:
NCT06618001
Condition:
Leukemia, Myeloid, Acute
Myelodysplastic Neoplasms
Conditions: Official terms:
Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-89853413
Description:
JNJ-89853413 will be administered.
Arm group label:
JNJ-89853413
Summary:
The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and
tolerability, and to identify the recommended Phase 2 dose[s] (RP2D[s]) in participants
with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood
cancer that has come back after treatment/or has stopped responding to treatment) or R/R
higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). The purpose of
Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in
participants with R/R AML or higher-risk types of MDS.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
1. relapsed/refractory acute myeloid leukemia (AML)
2. relapsed/refractory moderate high, high, or very high risk myelodysplastic
neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
- Body weight greater than or equals to (>=) 40 kilograms (kg)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Have adequate renal function defined as Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) >=40 milligrams
per minute (mL/min)
- Participants must have laboratory parameters in the required range
Exclusion Criteria:
- Has a medical history of clinically significant pulmonary compromise, particularly
the need for current supplemental oxygen use to maintain adequate oxygenation
- Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection
- Has known allergies, hypersensitivity, or intolerance to the excipients of
JNJ-89853413
- Had major surgery or had significant traumatic injury within 14 days of planned
first dose of JNJ-89853413
- Has known active central nervous system involvement
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 15, 2025
Completion date:
July 15, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618001
