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High-Dose therapy plus stem cell transplant shows promise for AML patients

NCT ID NCT00534469

Disease control Sponsor: City of Hope Medical Center Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a treatment for adults with acute myeloid leukemia (AML) in first remission. Patients received high-dose chemotherapy and radiation to kill cancer cells, followed by an autologous stem cell transplant (using their own stem cells) to restore blood cell production. After transplant, they also received aldesleukin (a protein that boosts the immune system) to help prevent relapse. The study aimed to see how well this approach worked and what side effects occurred.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
busulfan, etoposide, total-body irradiation, aldesleukin, filgrastim, cytarabine, idarubicin
What this could lead to
If successful, this approach could improve disease-free survival for AML patients in first remission, potentially reducing relapse risk.
What could go wrong
This is a completed phase 2 trial with only 60 participants, so results may not apply broadly. High-dose chemo and radiation carry significant side effects, and the transplant may not prevent relapse in all patients.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Feb 2000

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 60 years

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.

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * FAB types M0-2 and M4-M7 * No M3 disease * In first complete hematological remission as confirmed by marrow aspiration and biopsy * No cytogenetic abnormality in the remission marrow * In complete remission for less than 6 months * Patients who have been in complete remission for more than 6 months may be eligible upon approval of the principal investigator * No prior myeloproliferative disorder (e.g., chronic myeloid leukemia, myelofibrosis, essential thrombocytosis, or polycythemia vera) * No prior myelodysplasia or secondary leukemia PATIENT CHARACTERISTICS: * FEV\_1 \> 60% * DLCO \> 50% * Cardiac ejection fraction ≥ 50% * Creatinine clearance \> 60 mL/min * No severe chronic medical or psychological illness that, in the judgement of the principal investigator, would jeopardize the ability of the patient to tolerate aggressive chemotherapy * No HIV positivity * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * Prior consolidation therapy allowed * No concurrent use the following medications during aldesleukin therapy : * Corticosteroids (including blood product "pre-meds") * Pentoxifylline * IV or intrathecal methotrexate * IV immunoglobulin * Other cytokines or growth factors

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Conditions

The condition(s) this trial relates to.

acute basophilic leukemia acute erythroid leukemia acute megakaryoblastic leukemia acute monocytic leukemia acute myeloid leukemia Congenital Abnormalities leukemia Leukemia, Eosinophilic, Acute Leukemia, Myelomonocytic, Acute

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia

More trials for these conditions

Other studies related to the condition(s) this trial covers.