Completed

Autologous Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study

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What is being tested

filgrastim

+ busulfan

+ etoposide

BiologicalDrugProcedure
Who is being recruted

Bone Marrow Diseases+19

+ Chronic Disease

+ Hematologic Diseases

Until 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: June 12, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the overall survival and disease free survival of patients with acute myelogenous leukemia or myelodysplastic syndrome treated with busulfan and etoposide followed by autologous bone marrow transplantation and filgrastim (G-CSF). Assess the toxicities of this regimen in this patient population. Assess the hematologic effects and toxicities of G-CSF given in this setting to these patients. Determine whether G-CSF stimulates leukemic relapse in these patients. Determine whether G-CSF has an affect on platelet recovery in this setting in these patients. OUTLINE: Patients are stratified according to first, second, or third remission. Patients undergo bone marrow collection. Patients receive oral busulfan every 6 hours for 16 doses on days -5, -4, -3, and -2. Patients receive etoposide IV over 4 hours on days -4, -3, and -2. Bone marrow is reinfused 36-48 hours after the last dose of etoposide. Patients receive filgrastim (G-CSF) IV daily beginning 2-4 hours after bone marrow reinfusion until hematopoietic recovery. Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.

NCT00004899
Principal SponsorNorthwestern University
Last updated: June 12, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesCongenital AbnormalitiesLeukemia, Erythroblastic, AcuteLeukemiaLeukemia, Monocytic, AcuteMyelodysplastic SyndromesMyeloproliferative DisordersLeukemia, Myeloid, AcuteLeukemia, Promyelocytic, AcuteLeukemia, Myelomonocytic, AcuteMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Criteria

DISEASE CHARACTERISTICS: Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) of myelodysplastic syndrome or acute myelogenous leukemia (AML) of 1 of the following subtypes: Acute myeloblastic leukemia (FAB M1 or M2) Acute promyelocytic leukemia (FAB M3) Acute myelomonocytic leukemia (FAB M4) Acute monocytic leukemia (FAB M5) Acute erythroleukemia (FAB M6) In complete remission at time of marrow or stem cell harvesting No relapsed AML unless bone marrow or peripheral blood stem cells previously harvested in remission are available for transplantation May have had secondary AML that is either therapy related or that has evolved from an antecedent myelodysplastic syndrome History of CNS disease during induction allowed provided inactive and cytologic examination of spinal fluid from preharvest lumbar puncture shows no evidence of leukemia No occult or symptomatic leukemic meningitis during induction therapy or prior to bone marrow harvesting PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: Cardiac ejection fraction normal Pulmonary: FEV1 at least 60% predicted DLCO at least 60% predicted Other: HIV negative No evidence of persistent infections No concurrent organ damage or medical problems that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent antibiotics

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Google Maps
CompletedOne Study Center