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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005802
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 2, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia 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 Phase 1 Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 1999
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Relapsed acute myeloid leukemia or acute lymphoid leukemia after allogeneic peripheral blood stem cell transplantation (PBSCT), documented by 1 of the following:

    • Morphologic relapse defined as 1 or more of the following:

      • Peripheral blasts in absence of growth factor therapy
      • Bone marrow blasts greater than 5% of nucleated cells
      • Extramedullary (CNS, testicular, or other sites)
    • Flow cytometric relapse defined as appearance in peripheral blood or bone marrow of cells with abnormal immunophenotype consistent with leukemia recurrence and noted at pretransplant
    • Cytogenetic relapse defined as:

      • Appearance in 1 or more metaphases from bone marrow or peripheral blood cells of nonconstitutional cytogenetic abnormality noted in at least 1 cytogenetic study performed prior to transplant OR
      • New abnormality known to be associated with leukemia
  • Allogeneic PBSCT from related (HLA identical and 1 antigen mismatch) OR unrelated (match) donor

    • Must have achieved complete remission after PBSCT
  • Current donor must be same as prior donor

    • Age 10 and over



  • Not specified

Performance status:

  • SWOG 0-2

Life expectancy:

  • At least 3 months


  • See Disease Characteristics


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 2.0 mg/dL


  • No congestive heart failure requiring diuretics
  • No uncontrolled arrhythmia


  • No pulmonary dysfunction requiring oxygen therapy
  • No pneumonia or severe obstruction
  • FEV_1 at least 50% of predicted OR no greater than 50% decline from baseline
  • No severe restrictive lung disease (total lung capacity less than 60% or 50% declined from baseline) not due to leukemia


  • No sepsis, aspergillosis, or other active infection


Biologic therapy:

  • See Disease Characteristics


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No concurrent cyclosporine or tacrolimus during induction chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005802

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Mary E. D. Flowers, MD Fred Hutchinson Cancer Research Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00005802     History of Changes
Other Study ID Numbers: 1380.00
CDR0000067777 ( Registry Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 2, 2010
Last Verified: March 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Fludarabine phosphate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors