Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed Physiologic 65 and under NCI NU-91H1T NCI-G00-1688, NCT00004899

Objectives

1. 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).
2. Assess the toxicities of this regimen in this patient population.
3. Assess the hematologic effects and toxicities of G-CSF given in this setting to these patients.
4. Determine whether G-CSF stimulates leukemic relapse in these patients.
5. Determine whether G-CSF has an affect on platelet recovery in this setting in these patients.

Entry 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

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

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

Expected Enrollment

A total of 20-30 patients will be accrued for this study within 2 years.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Martin Tallman, MD, Protocol chair		Ph: 312-695-0990

Registry Information
Official Title		Autologous Bone Marrow Transplantation for Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study
Trial Start Date		1999-10-28
Trial Completion Date		2004-08-17
Registered in ClinicalTrials.gov		NCT00004899
Date Submitted to PDQ		2000-01-12
Information Last Verified		2004-11-08
NCI Grant/Contract Number		CA60553

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