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Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients

Phase 2
16 Years
60 Years
Open (Enrolling)

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Trial Information

Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients


- To evaluate the efficacy and toxicity of a preparative regimen comprising busulfan,
etoposide, and fractionated total-body irradiation followed by autologous stem cell
transplantation and aldesleukin after treatment with consolidation therapy comprising
high-dose cytarabine with or without idarubicin in patients with acute myeloid leukemia
in first remission.

- To estimate the long-term disease-free survival of patients treated with this regimen.

- To further evaluate the effect of prognostic factors (e.g., cytogenetics, WBC at
presentation, and number of courses of induction therapy required to achieve remission)
on the outcome of autologous stem cell transplantation and targeted busulfan dose.


- Consolidation therapy: Patients who received prior consolidation therapy are evaluated
to determine the need for additional consolidation therapy. Patients who have not
received prior consolidation therapy receive high-dose cytarabine IV over 3 hours every
12 hours on days 1-4 and idarubicin* IV over 5-10 minutes on days 1-3.

NOTE: *Patients with good risk cytogenetics t(8;21), inv(16), or t(16;16) or patients who
received > 200 mg/m² of anthracycline do not receive idarubicin.

- Stem cell collection: All patients receive filgrastim (G-CSF) IV or subcutaneously (SC)
twice daily beginning 7 days after completion of high-dose cytarabine and continuing
until peripheral blood stem cell (PBSC) collection is completed. Patients who do not
have an adequate number of PBSCs collected also undergo bone marrow collection.

- Preparative regimen: Patients receive busulfan IV over 2 hours on days -13 and -11 to
-7 and etoposide IV on day -2. Patients also undergo fractionated total-body
irradiation on days -6 to -3 for a total of 8-10 fractions.

- Autologous stem cell transplantation: Patients undergo autologous stem cell
transplantation using PBSCs (with or without bone marrow) on day 0. Patients receive
G-CSF IV or SC daily beginning on day 5 and continuing until blood counts recover.

- Interleukin therapy: Within 100 days post-transplantation, patients receive aldesleukin
IV continuously on days 1-4 and 9-18.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


- Diagnosis of acute myeloid leukemia (AML)

- FAB types M0-2 and M4-M7

- No M3 disease

- In first complete hematological remission as confirmed by marrow aspiration and

- No cytogenetic abnormality in the remission marrow

- In complete remission for less than 6 months

- Patients who have been in complete remission for more than 6 months may be
eligible upon approval of the principal investigator

- No prior myeloproliferative disorder (e.g., chronic myeloid leukemia, myelofibrosis,
essential thrombocytosis, or polycythemia vera)

- No prior myelodysplasia or secondary leukemia


- FEV_1 > 60%

- DLCO > 50%

- Cardiac ejection fraction ≥ 50%

- Creatinine clearance > 60 mL/min

- No severe chronic medical or psychological illness that, in the judgement of the
principal investigator, would jeopardize the ability of the patient to tolerate
aggressive chemotherapy

- No HIV positivity

- Not pregnant

- Negative pregnancy test


- Prior consolidation therapy allowed

- No concurrent use the following medications during aldesleukin therapy :

- Corticosteroids (including blood product "pre-meds")

- Pentoxifylline

- IV or intrathecal methotrexate

- IV immunoglobulin

- Other cytokines or growth factors

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Efficacy of preparative therapy as measured by 2- and 5-year disease-free survival

Safety Issue:


Principal Investigator

Anthony S. Stein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute basophilic leukemia
  • adult acute eosinophilic leukemia
  • adult erythroleukemia (M6a)
  • adult pure erythroid leukemia (M6b)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute monoblastic leukemia (M5a)
  • adult acute monocytic leukemia (M5b)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myelomonocytic leukemia (M4)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid