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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: May 3, 2005
Last updated: March 5, 2015
Last verified: March 2015

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 Intervention Phase
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 79
Study Start Date: April 2005
Study Completion Date: November 2014
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00109837

  Show 78 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Jerry Radich, MD Fred Hutchinson Cancer Research Center
Principal Investigator: Frederick R. Appelbaum, MD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Southwest Oncology Group Identifier: NCT00109837     History of Changes
Other Study ID Numbers: S0333
U10CA032102 ( US NIH Grant/Contract Award Number )
S0333 ( Other Identifier: SWOG )
Study First Received: May 3, 2005
Results First Received: April 4, 2012
Last Updated: March 5, 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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Trimethoprim, Sulfamethoxazole Drug Combination
Immunosuppressive Agents
Immunologic Factors processed this record on April 28, 2017