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NOT YET RECRUITING
NCT07157514
PHASE2/PHASE3

Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML

Sponsor: Actinium Pharmaceuticals

View on ClinicalTrials.gov

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

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

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.