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A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Leukemia, Myeloid, Acute
Myelodysplastic Neoplasms
Clinicaltrials.gov:
EU CTIS:
#2024-513199-16-00
Other:
#89853413AML1001
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Trials at a glance
Status
Enrolling
Condition
Leukemia, Myeloid, Acute
Myelodysplastic Neoplasms
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
JNJ-89853413
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
January 14, 2025
Trial end date
August 15, 2028
CT.gov ID
#NCT06618001
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
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.
Primary outcome measures
- Number of Participants with Adverse events (AEs) by Severity
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
Secondary outcome measures
- Serum Concentration of JNJ- 89853413
- Area Under the Plasma Concentration-time (AUC[t]) Curve of JNJ-89853413
- Maximum Serum Concentration (Cmax) of JNJ-89853413
- Trough Observed Serum Concentration (Ctrough) of JNJ-89853413
- Number of Participants with Presence of anti-drug Antibodies of JNJ-89853413
- Complete Response (CR) in Acute Myeloid Leukemia (AML)
- Overall Response (OR) in Myelodysplastic Neoplasms (MDS)
- Complete Response in MDS
- Duration of Response (DOR)
- Time to response (TTR)
- Number of Participants Achieving Transfusion independence
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