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AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION: A PHASE II STUDY


Phase 2
15 Years
69 Years
Not Enrolling
Both
Leukemia

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Trial Information

AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION: A PHASE II STUDY


OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and
filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral
blood stem cell transplantation to generate a 2-year disease-free survival rate in at least
30% of patients with acute myeloid leukemia (AML) in second complete remission. II.
Determine whether the treatment-related mortality can be limited to less than 20% in
patients treated with this regimen. III. Determine whether adequate numbers of PBSC can be
collected in these patients. IV. Determine the engraftment kinetics of primed PBSC obtained
from these patients.

OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours
and etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously
(SC) beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are
harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells.
Conditioning: Beginning at least 4 weeks after hospital discharge for mobilization and
harvest and when blood counts recover, patients receive oral busulfan every 6 hours on days
-7 to -4 and etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is
administered SC beginning on day 0 and continuing until blood counts recover. Patients with
documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1
week or greater before and/or after PBSC transplantation for a total of 6 doses. Patients
are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) in second complete
remission (CR) for 30 days to less than 1 year before study entry Second CR defined by the
following: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Normal
bone marrow morphology with no excess blasts (greater than 5%) No myelodysplasia No
extramedullary or CNS leukemia Initial diagnosis of de novo AML (M0-M7) No prior
myelodysplasia No myeloproliferative disease No secondary AML Cytogenetics not required No
cytogenetic evidence of persistent leukemia if cytogenetics performed

PATIENT CHARACTERISTICS: Age: 15 to 69 Hematopoietic: See Disease Characteristics
Granulocyte count at least 1,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than
3 times normal Alkaline phosphatase less than 3 times normal No cirrhosis or chronic
hepatitis Biopsy required if chronic liver disease suspected (history of alcohol abuse or
possible hepatitis) Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow/stem cell transplantation
Chemotherapy: Prior non-ablative chemotherapy at initial diagnosis, during initial
remission, or as reinduction therapy (to produce current second remission) allowed At
least 4 weeks since hospital discharge after reinduction therapy Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified Other: No prior
post-remission therapy for second remission

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Charles A. Linker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000064734

NCT ID:

NCT00002768

Start Date:

June 1996

Completion Date:

March 2009

Related Keywords:

  • Leukemia
  • adult 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)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute monocytic leukemia (M5b)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503