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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


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mary E. D. Flowers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1380.00

NCT ID:

NCT00005802

Start Date:

June 1999

Completion Date:

March 2005

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Lymphoid

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109