Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00002665

SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia

Official Title:

TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE, WITH OR WITHOUT PIXY, IN PREVIOUSLY UNTREATED PATIENTS, FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FIRST COMPLETE REMISSION

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without bone marrow transplantation in treating patients who have acute lymphocytic leukemia.

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia FAB class L1-L2 Mixed immunophenotypic markers with no cytochemical myeloid markers allowed No non-Hodgkin's lymphoma No chronic myelogenous leukemia in blast crisis Concurrent registration on the cytogenetics protocol SWOG-9007 required

PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: SWOG 0-3 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times normal (unless elevation due to leukemia) AST no greater than 3 times normal (unless elevation due to leukemia) No chronic liver disease Renal: Creatinine no greater than 2 times normal Cardiovascular: Left ventricular ejection fraction at least 50% by MUGA or echocardiogram No symptomatic congestive heart failure No symptomatic coronary artery disease No cardiomyopathy No uncontrolled arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior remission induction chemotherapy for acute lymphocytic leukemia

Disease(s) and\or Condition(s)

Leukemia

Neutropenia

Thrombocytopenia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: asparaginase
    • Description: 10,000 units/d IV or IM 15 - 24
    • Arm Group Labels:
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: con: 650 mg/m2 IV 1, 15, 29 maint: 650 mg/m2 IV 1
    • Arm Group Labels:
    • Type: DRUG
    • Name: cytarabine
    • Description: cons: 75 mg/m2/d IV Push 2 - 5, 9 - 12, 6 - 19, 23 - 26
    • Arm Group Labels:
    • Type: DRUG
    • Name: daunorubicin hydrochloride
    • Description: ind: 60 mg/m2 IV 22 and 23
    • Arm Group Labels:
    • Type: DRUG
    • Name: dexamethasone
    • Description: main: 10 mg/m2/day PO 1 - 28
    • Arm Group Labels:
    • Type: DRUG
    • Name: doxorubicin hydrochloride
    • Description: main: 25 mg/m2 IV 1, 8, 15, and 22
    • Arm Group Labels:
    • Type: DRUG
    • Name: etoposide
    • Description: 60 mg/kg based on ideal body weight day -3
    • Arm Group Labels:
    • Type: DRUG
    • Name: leucovorin calcium
    • Description: 5 mg q 6 hours for 4 doses, PO 1, 3, 8, 11 after each methotrexate if WBC \< 3,000 /μl
    • Arm Group Labels:
    • Type: DRUG
    • Name: mercaptopurine
    • Description: con: 60 mg/m2 PO 1 - 28
    • Arm Group Labels:
    • Type: DRUG
    • Name: methotrexate
    • Description: 10 mg/m2 IT or IV, d 2, 9, 16, and 23; Maximum 15 mg/admin
    • Arm Group Labels:
    • Type: DRUG
    • Name: prednisone
    • Description: ind: 60 mg/m2/d PO 1 - 21\*, 22 - 28 Patients will receive full dose through day 8 and then tapered to zero between Day 29 and 42. ind2: 60 mg/m2/d PO through day 42
    • Arm Group Labels:
    • Type: DRUG
    • Name: thioguanine
    • Description: main: 60 mg/m2/day PO 1 - 14
    • Arm Group Labels:
    • Type: DRUG
    • Name: vincristine sulfate
    • Description: ind: 1.4 mg/m2 2 mg max, IV 1, 8, 15, and 22 ind2: 1.4 mg/m2 2 mg max IV 29 and 36 main: 1.5 mg/m2 2 mg max, IV 1, 8, 15, and 22
    • Arm Group Labels:
    • Type: PROCEDURE
    • Name: allogeneic bone marrow transplantation
    • Description: day 0
    • Arm Group Labels:
    • Type: RADIATION
    • Name: radiation therapy
    • Description: day -7 through day -4 total dose of radiation is 1,320 cGy.
    • Arm Group Labels:
Sponsor
  • SWOG Cancer Research Network