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Multicenter Phase II Study of Radiolabled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-identical Related Marrow Transplantation


Phase 2
16 Years
55 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Multicenter Phase II Study of Radiolabled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-identical Related Marrow Transplantation


OBJECTIVES:

- Determine the disease-free and overall survival of patients with acute myelogenous
leukemia in first remission treated with busulfan and cyclophosphamide plus iodine I
131 monoclonal antibody BC8 followed by HLA identical related bone marrow
transplantation.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive a test dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB BC8) IV,
then about 2 weeks later, on day -13, a therapeutic dose of I131 MOAB BC8 IV is
administered. Patients then receive oral busulfan every 6 hours on days -7 to -4 (16 doses)
and cyclophosphamide IV on days -3 and -2. Donor bone marrow is infused on day 0.

Patients are followed at 6, 9, and 12 months, then every 6 months for 1 year, then annually
thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Acute myelogenous leukemia in first remission

- No prior or concurrent CNS involvement by leukemia

- Genotypically or phenotypically HLA matched family member available as donor

PATIENT CHARACTERISTICS:

Age

- 16 to 55

Performance status

- Not specified

Life expectancy

- More than 60 days

Hematopoietic

- Not specified

Hepatic

- Bilirubin less than 1.5 mg/dL

- AST no greater than 1.5 times upper limit of normal

- No current hepatitis

- No high risk for developing veno-occlusive disease of the liver

Renal

- Creatinine less than 2.0 mg/dL

Other

- HIV negative

- No major infection

- No perceived inability to tolerate study procedures, particularly treatment in
radiation isolation

- No circulating antibody to mouse immunoglobulin

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to maximum tolerated levels to any normal organ

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John Pagel, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1470.00

NCT ID:

NCT00005940

Start Date:

October 1999

Completion Date:

December 2003

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109