Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed Not specified NCI FHCRC-1380.00 NCI-H00-0057, NCT00005802

Objectives

1. 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.
2. Determine the toxicity and efficacy of this regimen in these patients.

Entry Criteria

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

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

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
• FEV₁ 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

Expected Enrollment

Approximately 11-15 patients per year will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Mary Flowers, MD, Protocol chair		Ph: 206-667-5160

Registry Information
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
Trial Start Date		1999-06-23
Registered in ClinicalTrials.gov		NCT00005802
Date Submitted to PDQ		2000-03-15
Information Last Verified		2005-01-29
NCI Grant/Contract Number		CA 18029, CA15704

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