Leukemia Clinical Trial
Official title:
Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus No Treatment (Standard of Care) in Patients With Acute Myeloid Leukemia in First or Subsequent Complete Remission (CR)
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid
leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of
relapse in patients with acute myeloid leukemia in remission.
PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus
histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in
remission following previous therapy.
OBJECTIVES: I. Compare the efficacy of interleukin-2 plus histamine dihydrochloride
(Maxamine) vs no further therapy in prolonging the leukemia free survival in patients with
acute myeloid leukemia in first or subsequent complete remission (CR) following
consolidation therapy. II. Compare the relapse rate, overall survival, and quality of life
in this patient population treated with interleukin-2 plus Maxamine vs no further therapy.
III. Compare the remission inversion rate in patients in subsequent CR with this treatment
regimen vs no further therapy.
OUTLINE: This is a randomized, open label, parallel, multicenter study. Patients are
stratified according to complete remission (first vs subsequent). Patients are randomized to
one of two treatment arms. Arm I: Following consolidation chemotherapy or autologous stem
cell transplantation, patients receive interleukin-2 subcutaneously followed by histamine
dihydrochloride subcutaneously over 5-7 minutes twice daily on days 1-21. Treatment repeats
every 6 weeks for 3 courses and then every 9 weeks for 7 courses in the absence of disease
relapse or unacceptable toxicity. Arm II: Patients receive no further therapy following
consolidation chemotherapy or autologous stem cell transplantation. Quality of life is
assessed prior to study, and at visits 6, 7, 10, 11, 16, 17, and 22. Patients are followed
for relapse and survival every 3 months for 2.5 years.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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