NCT07157514 - Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML | Biotech Hunter

Enrollment

306

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

February 28, 2029

Study Completion Date

February 28, 2034

Conditions

Acute LeukemiaMyeloid LeukemiaAcute Myelogenous LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia, in RelapseMyelogenous LeukemiaMyelogenous Leukemia, AcuteMyelogenous Leukemia in RelapseTransplant-Related DisorderAllogeneic DiseaseRefractory AML

Interventions

DRUG

131I-apamistamab

Iodine-131 radiolabeled anti-CD45 monoclonal antibody (apamistamab). Administered IV as a dosimetric dose followed by treatment dose.

DRUG

Fludarabine

Fludarabine phosphate, 30 mg/m² IV daily on Days -6 through -2.

DRUG

Cyclophosphamide

RADIATION

Total Body Irradiation (TBI)

TBI, 200 cGy on Day -1 prior to HSCT.

BIOLOGICAL

Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Unmodified, G-CSF-mobilized donor stem cells infused on Day 0.