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


Phase 2
N/A
65 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Martin S. Tallman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 91H1T

NCT ID:

NCT00004899

Start Date:

October 1999

Completion Date:

August 2004

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia in remission
  • childhood acute myeloid leukemia in remission
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute promyelocytic leukemia (M3)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • childhood acute myeloblastic leukemia without maturation (M1)
  • childhood acute myeloblastic leukemia with maturation (M2)
  • childhood acute promyelocytic leukemia (M3)
  • childhood acute myelomonocytic leukemia (M4)
  • childhood acute monoblastic leukemia (M5a)
  • childhood acute monocytic leukemia (M5b)
  • childhood acute erythroleukemia (M6)
  • secondary acute myeloid leukemia
  • adult acute monocytic leukemia (M5b)
  • previously treated myelodysplastic syndromes
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • atypical chronic myeloid leukemia
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611