Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00558519
  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) may kill more cancer cells.

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


Condition Intervention Phase
Leukemia
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: thioguanine
Drug: vincristine sulfate
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Mercaptopurine 6-Mercaptopurine Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Methotrexate Vincristine sulfate Vincristine Thioguanine Pegaspargase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: An Intergroup Phase II Clinical Trial for Adolescents and Young Adults With Untreated Acute Lymphoblastic Leukemia (ALL)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response rate [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Outcomes of adolescent and young adult patients treated on this study compared with those of patients treated per COG-AALL0232 [ Designated as safety issue: No ]
  • Adherence of adult hematologists/oncologists and their patients to a "pediatric" acute lymphoblastic leukemia treatment regimen and identification of reasons for variances [ Designated as safety issue: No ]
  • Outcomes of patients treated on this study according to pretreatment characteristics such as age, gender, white blood cell count, other hematologic parameters, blood chemistry, immunophenotype, cytogenetics and molecular genetic characteristics [ Designated as safety issue: No ]
  • Outcomes of patients treated on this study according to treatment variables such as treatment site (academic center or community), and protocol adherence [ Designated as safety issue: No ]
  • Analysis and description of the outcomes of patients treated on this study according to baseline psychosocial characteristics, demographics, and family support [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2007
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia (ALL)

    • B-precursor or T-precursor ALL
    • No Burkitt type leukemia (FAB L3; SIg positive; t(8;14) or variant)
    • No known Ph+ ALL at time of diagnosis
  • Enrollment on CALGB-C10001 (or its successor trial) for CALGB patients with Philadelphia-positive ALL take priority over enrollment on this protocol

    • Patients enrolled on this study but are later found to meet the following criteria for Ph+ ALL eligibility criteria for protocol CALGB-C10001 (or its successor trial) are removed from this study and enrolled on CALGB-C10001 (or its successor study):

      • BCR-ABL fusion transcript determined by FISH or RT-PCR
      • t(9;22)(q34;q11) or variant determined by cytogenetics
  • All CALGB patients are required to participate in CALGB-8461
  • All SWOG patients are required to participate in SWOG-9007

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • No Down syndrome

PRIOR CONCURRENT THERAPY:

  • No prior therapy for acute leukemia except emergency therapy (i.e., corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys
  • Single-dose intrathecal cytarabine is allowed prior to registration for patient convenience provided systemic chemotherapy begins within 72 hours of intrathecal therapy
  • Prior steroid therapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558519

  Show 147 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
Investigators
Study Chair: Richard A. Larson, MD University of Chicago
Investigator: John C. Grecula, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Study Chair: Selina M. Luger, MD University of Pennsylvania
Study Chair: Anjali Advani, MD The Cleveland Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Bleyer A: Older adolescents and young adults with acute lymphoblastic leukemia (ALL) in the United States: from the lowest to highest death rate and number of deaths--more rationale for the CALBG-SWOG-ECOG C10403 trial based on COG AALL0232. [Abstract] J Clin Oncol 26 (Suppl 15): A-18034, 2008.

Study ID Numbers: CDR0000574230, CALGB-10403, ECOG C10403, SWOG C10403
Study First Received: November 14, 2007
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00558519  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
B-cell adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia

Study placed in the following topic categories:
Dexamethasone
Daunorubicin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Thioguanine
Vincristine
Cyclophosphamide
6-Mercaptopurine
Doxorubicin
Acute lymphoblastic leukemia, adult
Folic Acid
Pegaspargase
Leukemia
Lymphatic Diseases
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Dexamethasone acetate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Abortifacient Agents
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Immunosuppressive Agents
Antiviral Agents

ClinicalTrials.gov processed this record on January 16, 2009