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Radioactive antibody could boost stem cell transplant success in tough leukemia

NCT ID NCT07157514

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 306 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Feb 2034

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

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