CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
aldesleukin +9 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00534469
NCT00534469Phase 2Completed

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

City of Hope Medical Center·interventional·Posted Sep 24, 2007·Updated Dec 2, 2025

In Brief

A Phase 2 clinical trial evaluating aldesleukin, filgrastim, and 8 other interventions for Leukemia. Completed, enrolled 60 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
Countries--

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2007
Enrollment StartFeb 8, 2000
Primary CompletionDec 31, 2022
Study CompletionJul 16, 2025
TodayJul 2, 2026
Enrollment to primary: 22.9 yearsPosted 18.8 years ago

Interventions

aldesleukinbiological

filgrastimbiological

busulfandrug

cytarabinedrug

etoposidedrug

idarubicindrug

autologous hematopoietic stem cell transplantationprocedure

bone marrow transplantationprocedure

peripheral blood stem cell transplantationprocedure

total-body irradiationradiation