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NCT00534469CompletedPhase 2

Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R

Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients </=60 Years of Age Using Busulfan/Fractionated Total Body Irradiation (FTBI) and VP16 as the Preparative Regimen

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy and radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep cancer cells from coming back after transplant. PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and etoposide together with total-body irradiation followed by autologous stem cell transplant and aldesleukin works in treating patients with acute myeloid leukemia in first remission.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (actual)
First submitted
20 Sept 2007
Start date
8 Feb 2000
Primary completion date
31 Dec 2022
Lead sponsor
City of Hope Medical Center
NCT number
NCT00534469

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 60
  • From 8 Feb 2000 to the primary completion date, 31 Dec 2022
  • 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.

Criteria the registry did not label

  • 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

Age in the registry: 16 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.