Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow.

2R/R AML is defined as one of the following: Primary induction failure after ≥2 cycles of therapy, first early relapse after remission <6 months, relapse refractory to salvage combination therapy or second or subsequent relapse

Documented CD45 expression by leukemic cells via flow cytometry.

≥18 years of age and not suitable for myeloablative conditioning regimen.

Disqualifiers

Positive human anti-mouse antibody (HAMA) at screening.

>20% leukemic blasts in marrow.

Prior radiation to maximally tolerated levels of any critical organ.

Active CNS leukemia (blasts in CSF or CNS chloromas).

Trial design

Treatments tested in this trial

  • 131I-apamistamab
  • Fludarabine
  • Cyclophosphamide
  • Total Body Irradiation (TBI)
  • Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Treatment groups

306 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Actinium Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov