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Busulfan, Etoposide, and Total-Body Irradiation Followed by Autologous Stem Cell Transplant and Aldesleukin in Treating Patients With Acute Myeloid Leukemia in First Remission

Information source: City of Hope Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: aldesleukin (Biological); filgrastim (Biological); busulfan (Drug); cytarabine (Drug); etoposide (Drug); idarubicin (Drug); autologous hematopoietic stem cell transplantation (Procedure); bone marrow transplantation (Procedure); peripheral blood stem cell transplantation (Procedure); total-body irradiation (Radiation)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: City of Hope Medical Center

Official(s) and/or principal investigator(s):
Anthony S. Stein, MD, Study Chair, Affiliation: Beckman Research Institute


RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy and radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep cancer cells from coming back after transplant. PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and etoposide together with total-body irradiation followed by autologous stem cell transplant and aldesleukin works in treating patients with acute myeloid leukemia in first remission.

Clinical Details

Official title: Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Toxicity of preparative therapy

Feasibility of administration and ability to tolerate aldesleukin after transplantation

Secondary outcome: Effect of cytogenetics, WBC at presentation, targeted busulfan dose, and number of courses of induction therapy required to achieve remission on possible prognostic factors for relapse, disease-free survival, and overall survival

Detailed description: OBJECTIVES:

- 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. OUTLINE:

- 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.


Minimum age: 16 Years. Maximum age: 60 Years. Gender(s): Both.



- 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

Locations and Contacts

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2000
Last updated: January 12, 2015

Page last updated: August 23, 2015

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