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Phase III Study of MDR Modulation With PSC-833 (NSC #648265) Followed by Immunotherapy With rIL-2 (NSC #373364) vs. No Further Therapy in Previously Untreated Patients With AML >60 Years


Phase 3
60 Years
N/A
Not Enrolling
Both
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Untreated Adult Acute Myeloid Leukemia

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Trial Information

Phase III Study of MDR Modulation With PSC-833 (NSC #648265) Followed by Immunotherapy With rIL-2 (NSC #373364) vs. No Further Therapy in Previously Untreated Patients With AML >60 Years


PRIMARY OBJECTIVES:

I. To determine whether the addition of PSC-833 to induction chemotherapy improves complete
response rates and whether the addition of PSC-833 to induction and consolidation
chemotherapy improves survival for patients with AML >= 60 years.

II. To determine whether the administration of low-dose, subcutaneous rIL-2 immunotherapy
with intermittent high-dose boluses after chemotherapy prolongs disease-free survival.

OUTLINE: This is a partially randomized, multicenter study. Patients are stratified
according to participating center and disease characteristics (de novo acute myeloid
leukemia (AML) versus AML with antecedent myelodysplasia). Patients are randomized to one of
two maintenance therapy arms.

Arm I: Patients receive cytarabine IV continuously over 7 days and daunorubicin IV bolus
followed by etoposide IV over 2 hours on days 1-3.

Arm II: Patients receive treatment as in arm I with the addition of PSC 833 induction. A
loading dose of PSC 833 IV is given over 2 hours, followed by a 74-hour continuous infusion
of PSC 833 beginning 2 hours before daunorubicin and etoposide. Patients may receive a
second induction course if residual leukemia is present in the bone marrow. Patients who
experience a complete remission (CR) and meet certain other criteria receive postremission
chemotherapy consisting of cytarabine IV continuously over 5 days plus daunorubicin IV
followed by etoposide IV over 2 hours on days 1 and 2. Patients who are randomized to
receive PSC 833 during induction chemotherapy receive a loading dose of PSC 833 before
beginning a 48-hour continuous infusion of PSC 833 concurrently with
cytarabine/daunorubicin/etoposide postremission chemotherapy.

After completing postremission chemotherapy, patients are randomized to a no further
treatment group or interleukin-2 (IL-2) immunotherapy. Treatment begins within 5 months of
postremission chemotherapy. IL-2 immunotherapy consists of low-dose subcutaneous (SC) IL-2
on days 1-14, 19-28, 33-42, 47-56, 61-70, and 75-90 and high-dose bolus SC IL-2 on days
15-17, 29-31, 43-45, 57-59, and 71-73.

Patients are followed every 2 months for 2 years, every 6 months for 2 years, annually until
the tenth year, and then at relapse.


Inclusion Criteria:



- Unequivocal histologic diagnosis of AML, FAB classification (M0-M7), excluding M3
(acute promyelocytic leukemia); patients with a history of antecedent myelodysplasia
remain eligible for treatment on this trial

- No prior treatment for acute leukemia or myelodysplasia with four permissible
exceptions:

- Emergency leukapheresis;

- Emergency treatment for hyperleukocytosis with hyroxyurea;

- Cranial RT for CNS leukostasis (one dose only);

- Growth factor/cytokine support.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Description:

Analyzed by intention to treat.

Outcome Time Frame:

From second randomization to relapse or death, assessed up to 10 years

Safety Issue:

No

Principal Investigator

Maria Baer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02793

NCT ID:

NCT00003190

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606