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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


Phase 2
N/A
65 Years
Open (Enrolling)
Both
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

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Trial Information

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


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 high-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.


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 cluster of
differentiation [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 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival of patients on busulfan and etoposide followed by stem cell rescue and aldesleukin

Outcome Description:

Estimated by the method of Kaplan and Meier.

Outcome Time Frame:

At 3 years

Safety Issue:

No

Principal Investigator

Leona Holmberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

1315.00

NCT ID:

NCT00003875

Start Date:

November 1998

Completion Date:

Related Keywords:

  • 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
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109