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

Sponsor
Actinium Pharmaceuticals
Study ID
NCT07157514
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 131I-apamistamab — DRUG
    Iodine-131 radiolabeled anti-CD45 monoclonal antibody (apamistamab). Administered IV as a dosimetric dose followed by treatment dose.
  • Fludarabine — DRUG
    Fludarabine phosphate, 30 mg/m² IV daily on Days -6 through -2.
  • Cyclophosphamide — DRUG
    Cyclophosphamide
  • Total Body Irradiation (TBI) — RADIATION
    TBI, 200 cGy on Day -1 prior to HSCT.
  • Allogeneic Hematopoietic Stem Cell Transplant (HSCT) — BIOLOGICAL
    Unmodified, G-CSF-mobilized donor stem cells infused on Day 0.

Study Details

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.

Key Dates

First listed
Sep 5, 2025
Start date
Jan 31, 2026
Status verified
Sep 2025
Primary completion
Feb 28, 2029
Completion
Feb 28, 2034

Study Design

Enrollment
306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Experimental: I131-apamistamab + Fludarabine + TBI
    Participants receive a dosimetric dose and then a treatment dose of I131-apamistamab (at the marrow dose selected in Phase 2), followed by fludarabine 30 mg/m² IV daily on Days -6 through -2 and total body irradiation (TBI) 200 cGy on Day -1 prior to allogeneic hematopoietic stem cell transplant (HSCT) on Day 0. Graft-versus-host disease (GvHD) prophylaxis per investigator's choice: * Post-transplant cyclophosphamide (50 mg/kg on Days +3 and +4) + tacrolimus + mycophenolate mofetil, OR * Low-dose methotrexate + tacrolimus.
  • Active Comparator: Arm B: Active Comparator - Standard of Care Conditioning Regimen
    Participants receive standard of care conditioning regimen prior to allogeneic hematopoietic stem cell transplant (HSCT) on Day 0 GvHD prophylaxis per investigator's choice: * Post-transplant cyclophosphamide (50 mg/kg on Days +3 and +4) + tacrolimus + mycophenolate mofetil, OR * Low-dose methotrexate + tacrolimus.

Primary Outcome Measure

Overall Survival (OS) -Phase 3 [ Time Frame: Up to 5 years post-randomization ]

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