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Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML
Sponsor: Actinium Pharmaceuticals
Summary
This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.
Official title: An Adaptive, Operationally Seamless Phase II / III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
306
Start Date
2026-01
Completion Date
2034-02
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
131I-apamistamab
Iodine-131 radiolabeled anti-CD45 monoclonal antibody (apamistamab). Administered IV as a dosimetric dose followed by treatment dose.
Fludarabine
Fludarabine phosphate, 30 mg/m² IV daily on Days -6 through -2.
Cyclophosphamide
Cyclophosphamide
Total Body Irradiation (TBI)
TBI, 200 cGy on Day -1 prior to HSCT.
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Unmodified, G-CSF-mobilized donor stem cells infused on Day 0.