Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT00003875 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Results First Posted
: June 5, 2017
Last Update Posted
: June 5, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Childhood Acute Myeloid Leukemia in Remission Recurrent Adult Acute Myeloid Leukemia Recurrent Childhood Acute Myeloid Leukemia | Drug: busulfan Drug: etoposide Biological: aldesleukin Procedure: peripheral blood stem cell transplantation | Phase 2 |
PRIMARY OBJECTIVES:
I. To evaluate the toxicity and overall survival of high dose Bu (busulfan)/VP-16 (etoposide) followed by post-transplant low-dose interleukin (IL)-2 (aldesleukin) in patients with AML.
SECONDARY OBJECTIVES:
I. To estimate the rate of relapse associated with this regimen.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive busulfan intravenously (IV) over 2 hours or orally (PO) every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin subcutaneously (SC) daily for 12 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Acute Myelogenous Leukemia With Busulfan and Etoposide Followed by Autologous or Syngeneic Stem Cell Rescue and Low-Dose Interleukin 2 (IL-2) Immunotherapy |
Actual Study Start Date : | October 13, 1998 |
Actual Primary Completion Date : | June 11, 2015 |
Actual Study Completion Date : | June 11, 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (chemo, stem cell rescue, interleukin therapy)
PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3. STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0. POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks. |
Drug: busulfan
Given PO or IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Biological: aldesleukin
Given SC
Other Names:
Procedure: peripheral blood stem cell transplantation
Undergo autologous or syngeneic stem cell rescue
Other Names:
|
- Overall Survival of Patients on Busulfan and Etoposide Followed by Stem Cell Rescue and Aldesleukin [ Time Frame: From date of transplant to date of death from any cause, assessed up to 178 months ]Estimated by the method of Kaplan and Meier.
- Toxicity Associated With High-dose Busulfan and Etoposide Followed by Stem Cell Rescue [ Time Frame: Day -7 of transplant to 100 days post transplant ]Toxicity is defined as any grade 3 or grade 4 toxicity per the Bearman toxicity grading criteria following Busulfan and Etoposide high-dose chemotherapy, stem cell transplant, and the inability to recover sufficiently by day 100 to start IL-2 therapy.
- Toxicity Associated With Aldesleukin Treatment After Stem Cell Rescue [ Time Frame: IL-2 administration to one month after completion of IL-2 treatment ]Toxicity during IL-2 therapy of any of the following per NCI Common Toxicity version 3: grade 2, 3, 4, or 5 CNS (except grade 0-3 malaise, fatigue, anxiety and depression) toxicity; grade 3, 4, or 5 non-CNS or non-hematologic toxicity; any grade 4 or 5 hematologic toxicity.
- Proportion of Patients Who Relapsed Associated With the Regimen [ Time Frame: From date of transplant to date of death from any cause, assessed up to 178 months ]

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Ages Eligible for Study: | up to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patient must have AML that falls into one of the following categories:
-
AML in 1st complete remission (CR) with intermediate or high risk of relapse following conventional therapy; at least, one of the following features is needed:
- Patient required more than one cycle of induction to achieve first CR
- White blood cell count (WBC) > 100,000/mm^3 at diagnosis
- Any of the following cytogenetic abnormalities: inv (3), t(3:3), del (5q) or -5, 11q23, del(7q) or -7, del (20q) or -20, abnormal 12p, +11 or t8
- Any other abnormalities or combination of abnormalities which would predict intermediate or high risk of relapse
- AML beyond first CR
- Any patient with an identical twin donor who also meets the criteria above
- Patients with AML in 1st CR should receive at least two cycles of consolidation chemotherapy prior to mobilization and transplant
- Patients must have an adequate number of stem cells previously collected (i.e., > 2 x 10^8 total nucleated cell [TNC] of bone marrow [BM]/kg or 4 x 10^6 [CD]34+ PBSC/kg, unless approved otherwise by Dr. Holmberg); prior to stem cell collection patients must be documented to be in remission and to have received two cycles of consolidation therapy after induction therapy
- Pre-Study tests have been performed
- Patient must sign an institutional review board (IRB) approved informed consent, conforming with federal and institutional guidelines
Exclusion Criteria:
- Patients with good risk AML defined by cytogenetic evaluation with these abnormalities: inversion 16 or t8;21
- Patient's life expectancy is severely limited by diseases other than AML
- Patient is human immunodeficiency virus (HIV) seropositive
- Patient is pregnant
- Patient's creatinine > 2.0 mg/dl
- Patient's total bilirubin > 2.0 mg/dl (unless Gilbert's disease)
- Or serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) >= 2.5 x upper limit of normal (ULN) not due to leukemia
- Patient has a history of congestive heart failure, uncontrolled arrhythmias or left ventricular ejection fraction (LVEF) < 50%
- Patient has an unrelated human leukocyte antigen (HLA) matched donor and is eligible for a higher priority Fred Hutchinson Cancer Research Center (FHCRC) protocol (for FHCRC patients only)
- Patient has an HLA matched or one antigen mismatch family donor available
- Patients with a significant active infection that precludes transplant
- Patients with a Karnofsky Performance Score less than 70

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003875
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Leona Holmberg | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
Responsible Party: | Leona Holmberg, Principal Investigator, Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00003875 History of Changes |
Other Study ID Numbers: |
1315.00 NCI-2011-00439 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 1315.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium ) P30CA015704 ( U.S. NIH Grant/Contract ) |
First Posted: | January 27, 2003 Key Record Dates |
Results First Posted: | June 5, 2017 |
Last Update Posted: | June 5, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Etoposide Etoposide phosphate Aldesleukin Busulfan Interleukin-2 Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Alkylating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Myeloablative Agonists Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |