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Trial record 17 of 83 for:    "Adult Acute Lymphocytic Leukemia" | "Antineoplastic Agents, Hormonal"

S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109837
Recruitment Status : Completed
First Posted : May 4, 2005
Results First Posted : August 23, 2012
Last Update Posted : March 25, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), and giving the drugs in different combinations may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin Drug: dexamethasone Drug: doxorubicin Drug: leucovorin Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone Drug: Asparaginase Drug: prednisone Drug: thioguanine Drug: vincristine Radiation: radiation therapy Drug: allopurinol Drug: bactrim Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy
Study Start Date : April 2005
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Induc x2, Consol, Maint
Induc 1: Allopurinol; Daunorubicin; Vincristine; Prednisone; asparaginase; Bactrim Induc 2: Allopurinol; cytarabine; Dexamethasone; filgrastim; mitoxantrone; Methotrexate; leucovorin Consol: Cyclophosphamide; cytarabine; 6-mercaptopurine; Methotrexate; filgrastim Maint:Course 1: 6-mercaptopurine; Methotrexate Course 2: Vincristine; doxorubicin; Dexamethasone Course 3: Cyclophosphamidee; thioguanine; cytarabine Course 4: 6-mercaptopurine; methotrexate
Biological: filgrastim
As needed per physician discretion

Drug: cyclophosphamide
Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1

Drug: cytarabine
Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13

Drug: daunorubicin
Induction: 60 mg/m2/d; IV; days 1, 2, and 3

Drug: dexamethasone
Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28

Drug: doxorubicin
Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22

Drug: leucovorin
For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC < 3,000

Drug: mercaptopurine
Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs

Drug: methotrexate
Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs

Drug: mitoxantrone
Induction 2: 80 mg/m2; IV; day 3

Drug: Asparaginase
Induction: 2,000 IU/m2; IM or IV; day 15

Drug: prednisone
Induction: 60 mg/m2/d; PO or IV; days 1-35

Drug: thioguanine
Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14

Drug: vincristine
Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22

Radiation: radiation therapy
For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.

Drug: allopurinol
300 mg/d PO Days 1-7

Drug: bactrim
1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone

Primary Outcome Measures :
  1. Continuous Complete Remission at 1 Year [ Time Frame: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year ]
    A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: Patients were assessed for adverse events after the induction cycle ]
    Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Morphologically confirmed acute lymphoblastic leukemia (ALL), meeting any of the following criteria:

    • FAB class L1 or L2 disease
    • Mixed lineage ALL
  • Ph-negative/BCR/ABL-negative
  • Newly diagnosed disease
  • Patients with the following diagnoses are not eligible:

    • FAB class L3 ALL
    • Non-Hodgkin's lymphoma
    • Chronic myelogenous leukemia in lymphoid blast crisis
    • Mixed lineage acute myeloid leukemia
    • Acute minimally differentiated myeloid leukemia (M0)
  • Must be registered on protocols SWOG-9007 AND SWOG-S9910



  • 18 to 64

Performance status

  • Zubrod 0-3

Life expectancy

  • Not specified


  • Not specified


  • No chronic liver disease
  • Hepatitis panel, including hepatitis B and C, negative

    • History of hepatitis A with positive antibody allowed


  • Creatinine ≤ 1.5 times upper limit of normal OR
  • Creatinine clearance > 60 mL/min


  • Left ventricular function normal

    • Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram
  • No symptomatic congestive heart failure
  • No coronary artery disease
  • No cardiomyopathy
  • No uncontrolled arrhythmia


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission


Biologic therapy

  • Not specified


  • No prior remission induction chemotherapy for ALL

    • Prior hydroxyurea to control WBC count allowed

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • No other prior treatment for ALL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109837

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Jerry Radich, MD Fred Hutchinson Cancer Research Center
Principal Investigator: Frederick R. Appelbaum, MD Fred Hutchinson Cancer Research Center

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Responsible Party: Southwest Oncology Group Identifier: NCT00109837     History of Changes
Other Study ID Numbers: S0333
U10CA032102 ( U.S. NIH Grant/Contract )
S0333 ( Other Identifier: SWOG )
First Posted: May 4, 2005    Key Record Dates
Results First Posted: August 23, 2012
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Southwest Oncology Group:
L1 adult acute lymphoblastic leukemia
L2 adult acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Antineoplastic Agents, Hormonal
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents