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Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
This study has been completed.
Study NCT00005802   Information provided by Fred Hutchinson Cancer Research Center
First Received: June 2, 2000   Last Updated: July 2, 2009   History of Changes

June 2, 2000
July 2, 2009
June 1999
March 2005   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00005802 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

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.

Phase I, Phase II
Interventional
Treatment
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
 
Clark JA, Turner ML, Howard L, Stanescu H, Kleta R, Kopp JB. Description of familial keloids in five pedigrees: evidence for autosomal dominant inheritance and phenotypic heterogeneity. BMC Dermatol. 2009 Jul 28;9:8.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
March 2005
March 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • SWOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No congestive heart failure requiring diuretics
  • No uncontrolled arrhythmia

Pulmonary:

  • 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

Other:

  • No sepsis, aspergillosis, or other active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent cyclosporine or tacrolimus during induction chemotherapy
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005802
 
CDR0000067777, FHCRC-1380.00, NCI-H00-0057
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Mary E. D. Flowers, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP