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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00109837
First received: May 3, 2005
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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
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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 to 64

Performance status

  • Zubrod 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

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

    • History of hepatitis A with positive antibody allowed

Renal

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

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior remission induction chemotherapy for ALL

    • Prior hydroxyurea to control WBC count allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other prior treatment for ALL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109837

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

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00109837     History of Changes
Other Study ID Numbers: CDR0000426447, U10CA032102, S0333
Study First Received: May 3, 2005
Results First Received: April 4, 2012
Last Updated: February 28, 2014
Health Authority: United States: Federal Government

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:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
6-Mercaptopurine
Allopurinol
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Mitoxantrone
Prednisone
Vincristine
BB 1101
Lenograstim
Trimethoprim-Sulfamethoxazole Combination
Dexamethasone acetate
Dexamethasone 21-phosphate

ClinicalTrials.gov processed this record on April 17, 2014