Chemotherapy (CT) Followed by Donor Lymphocyte Infusion (DLI) Plus Interleukin 2 (IL-2) for Patients With Relapse Acute Myeloid or Lymphoid Leukemia After Allogeneic Hematopoietic Transplant
- Determine the maximum tolerated dose of interleukin-2 following donor lymphocyte
infusion and chemotherapy in patients with relapsed acute myeloid or lymphoid leukemia
after allogeneic peripheral blood stem cell transplantation.
- Determine the toxicity and efficacy of this regimen in these patients.
OUTLINE: This is a dose escalation study of interleukin-2 (IL-2). Patients are stratified
according to disease status after chemotherapy (acute myeloid leukemia (AML) in complete
remission (CR) vs acute lymphoid leukemia (ALL) or AML not in CR).
Patients receive one of three induction chemotherapy regimens, depending on type of
leukemia, prior treatment, and response.
- Regimen 1: Patients receive high dose cytarabine IV over 2 hours twice a day on days 1,
3, and 5.
- Regimen 2: Patients receive mitoxantrone IV over 15 minutes and etoposide IV over 30
minutes on days 1-5.
- Regimen 3: Patients receive fludarabine IV over 30 minutes on days 1-5, cytarabine IV
over 2 hours on days 1-4, and filgrastim (G-CSF) subcutaneously beginning on day 1 and
continuing until blood counts recover.
Patients with extramedullary relapse receive local radiotherapy. Patients with ALL or CNS
relapse receive intrathecal methotrexate with or without hydrocortisone and cytarabine.
Patients receive one donor lymphocyte infusion IV over 15-30 minutes within 28-60 days after
starting chemotherapy. On the same day, IL-2 IV is administered over 24 hours for 5 days.
After 2 days rest, IL-2 is again administered continuously for 10 days.
Cohorts of 5 patients receive escalating doses of IL-2 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose at which no more than 2 of 5 patients
experience dose limiting toxicities. Up to 40 patients are treated at the MTD.
Patients are followed monthly for 3 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 11-15 patients per year will be accrued for this study.
Primary Purpose: Treatment
Mary E. D. Flowers, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|