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Radioactive antibody could boost stem cell transplant success in tough leukemia
NCT ID NCT07157514
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests a new approach for people with relapsed or refractory acute myeloid leukemia (AML) who have active disease. Before a stem cell transplant, patients receive a radioactive antibody (131I-apamistamab) along with chemotherapy and low-dose radiation to prepare the body. The goal is to see if this combination helps patients live longer and achieve remission. The trial has two parts: first finding the best dose, then comparing it to standard care in about 306 adults.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 131I-apamistamab (a radioactive antibody targeting cancer cells)
- What this could lead to
- If successful, this could offer a more effective transplant preparation for people with hard-to-treat AML, potentially improving survival and remission rates.
- What could go wrong
- This is an early-to-mid-stage trial, so the benefits are not proven. The treatment involves radiation and strong chemotherapy, which carry risks like severe side effects or transplant complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 306 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2034
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow. 2. 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 3. Documented CD45 expression by leukemic cells via flow cytometry. 4. ≥18 years of age and not suitable for myeloablative conditioning regimen. 5. Circulating blast count \<10,000/mm³ (hydroxyurea allowed). 6. Calculated creatinine clearance (Cockcroft-Gault) \>50 mL/min. 7. Adequate hepatic function: AST/ALT ≤2 × ULN; total bilirubin ≤1.5 × ULN (≤3 × ULN if due to underlying malignancy or Gilbert's). 8. Karnofsky performance score ≥70. 9. Expected survival \>60 days. 10. Central venous catheter line in place before study treatment. 11. 8/8 HLA-matched related or unrelated donor (HLA-A, HLA-B, HLA-C, DRB1). 12. Women of childbearing potential must be surgically sterile or use acceptable contraception through 1-year post-transplant. 13. Men with partners of childbearing potential must be surgically sterile or use acceptable contraception through 12 weeks after last dose. 14. Able to understand procedures, provide informed consent, and comply with study requirements. Exclusion Criteria: 1. Positive human anti-mouse antibody (HAMA) at screening. 2. \>20% leukemic blasts in marrow. 3. Prior radiation to maximally tolerated levels of any critical organ. 4. Active CNS leukemia (blasts in CSF or CNS chloromas). 5. Prior allogeneic or autologous HSCT. 6. Candidates suitable for myeloablative conditioning. 7. 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 8. QTcF \>450 ms after correction of electrolytes (unless paced rhythm or investigator deems eligible; cardiology consult optional). 9. Positive HIV, HBV, or HCV test (exceptions: vaccinated HBV, or positive hepatitis markers with adequate organ function). 10. Active, uncontrolled infection. 11. Acute promyelocytic leukemia (t\[15;17\]). 12. 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 13. Inability to tolerate diagnostic or therapeutic procedures, particularly radiation isolation. 14. Received anti-leukemic therapy within 14 days prior to randomization (hydroxyurea allowed up to day of 131I-apamistamab).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?