NCT00005802

Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. Treating donor white blood cells with interleukin-2 in the laboratory may help them kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-2 when given after chemotherapy and donor white blood cells and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoid leukemia.

Detailed description

OBJECTIVES: * 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	filgrastim
BIOLOGICAL	therapeutic allogeneic lymphocytes
DRUG	cytarabine
DRUG	etoposide
DRUG	fludarabine phosphate
DRUG	methotrexate
DRUG	mitoxantrone hydrochloride
DRUG	therapeutic hydrocortisone
RADIATION	radiation therapy

Timeline

• Start date: 1999-06-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2003-01-27
• Last updated: 2010-04-02

Locations

1 site across 1 country: United States