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

NCT07157514 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Acute Leukemia
  • Myeloid Leukemia
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia, in Relapse
  • Myelogenous Leukemia
  • Myelogenous Leukemia, Acute
  • Myelogenous Leukemia in Relapse
  • Transplant-Related Disorder
  • Allogeneic Disease
  • Refractory 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

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.

Sponsors & Collaborators

  • Actinium Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2029-02-28
Completion
2034-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07157514 on ClinicalTrials.gov