A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Last Updated April 2, 2025
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89853413AML1001
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 11 -
Sites
Sites -
Status
Recruiting
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.
CONDITIONS
- Leukemia, Myeloid, Acute
- Myelodysplastic Neoplasms
ELIGIBILITY
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 Pr
DETAILS
LOCATIONS
| Country (2) | City or Province (4) | Status |
| Canada | Toronto Princess Margaret Hospital |
RECRUITING
|
| Spain | Barcelona Hosp Clinic de Barcelona |
RECRUITING
|
| Spain | Madrid Hosp Univ Fund Jimenez Diaz |
RECRUITING
|
| Spain | Pamplona Clinica Univ. de Navarra |
RECRUITING
|
43.70011, -79.4163
41.38879, 2.15899
40.4165, -3.70256
42.81687, -1.64323
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