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Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

NCT00630565 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-01-29

Study results available
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Summary

RATIONALE: Giving chemotherapy and colony-stimulating factors, such as G-CSF, may increase the number of stem cells in the blood. The stem cells are collected from the patient's blood and stored. Chemotherapy or 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.

PURPOSE: This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.

Conditions

Interventions

BIOLOGICAL

sargramostim

Given subcutaneously (SC) 10 μg/kg/day from day +3 until apheresis is completed

DRUG

busulfan

4 mg/kg po in 4 divided doses (.8 mg/kg/dose orally every 6 hours) on days -7 through -4.

DRUG

cyclophosphamide

4 gm/m\^2 x 1 (day 0) and 60 mg/kg intravenous (IV) over 2 hours on days -3 and -2.

DRUG

dexamethasone

20 mg/m\^2 x 4 doses every 12 hours given intravenously (IV) push before cytoxan on day 0 and then every 12 hours

DRUG

etoposide

300 mg/m\^2/day x 2 days (day 0-1) over 3 hours intravenously (IV)

PROCEDURE

bone marrow transplantation

Day 0 infusion of bone marrow cells

PROCEDURE

hematopoietic stem cell transplantation

Stem cell infusion (\>48 hours after the last dose of cyclophosphamide)

PROCEDURE

peripheral blood stem cell transplantation

Day 0 infusion of peripheral blood stem cells

RADIATION

total-body irradiation

165 cGy/dose given twice a day on days -7 through -4.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Daniel J. Weisdorf, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-26
Primary Completion
2022-07-28
Completion
2022-07-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630565 on ClinicalTrials.gov