NCT07157514Not yet recruitingPhase 2/3
Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 306 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- Jan 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Actinium Pharmaceuticals
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07157514
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 306
- From Jan 2026 to the primary completion date, Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive human anti-mouse antibody (HAMA) at screening.
- Prior radiation to maximally tolerated levels of any critical organ.
- Prior allogeneic or autologous HSCT.
- Inability to tolerate diagnostic or therapeutic procedures, particularly radiation isolation.
- Received anti-leukemic therapy within 14 days prior to randomization (hydroxyurea allowed up to day of 131I-apamistamab).
Other illness
- Clinically significant cardiac disease, including: NYHA Class III or IV heart failure, Clinically significant arrhythmias (ventricular tachycardia, ventricular fibrillation, Torsade de Pointes), Myocardial infarction with uncontrolled angina within 6 months, Clinically significant congestive heart failure or cardiomyopathy
- Positive HIV, HBV, or HCV test (exceptions: vaccinated HBV, or positive hepatitis markers with adequate organ function).
- Active, uncontrolled infection.
- Active malignancy within 2 years, except: Myelodysplastic syndrome, Treated non-melanoma skin cancer, Completely resected stage 0-1 melanoma (\>1 year from resection), Carcinoma in situ or cervical intraepithelial neoplasia, Organ-confined prostate cancer without progression
Other
- \>20% leukemic blasts in marrow.
- Active CNS leukemia (blasts in CSF or CNS chloromas).
- Candidates suitable for myeloablative conditioning.
- QTcF \>450 ms after correction of electrolytes (unless paced rhythm or investigator deems eligible; cardiology consult optional).
- Acute promyelocytic leukemia (t\[15;17\]).
Who the study is looking for
- 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.
- Circulating blast count \<10,000/mm³ (hydroxyurea allowed).
- Calculated creatinine clearance (Cockcroft-Gault) \>50 mL/min.
- Adequate hepatic function: AST/ALT ≤2 × ULN; total bilirubin ≤1.5 × ULN (≤3 × ULN if due to underlying malignancy or Gilbert's).
- Karnofsky performance score ≥70.
- Expected survival \>60 days.
- Central venous catheter line in place before study treatment.
- 8/8 HLA-matched related or unrelated donor (HLA-A, HLA-B, HLA-C, DRB1).
- Women of childbearing potential must be surgically sterile or use acceptable contraception through 1-year post-transplant.
- Men with partners of childbearing potential must be surgically sterile or use acceptable contraception through 12 weeks after last dose.
- Able to understand procedures, provide informed consent, and comply with study requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.