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Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: M.D. Anderson Cancer Center
Novartis
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038610
  Purpose

The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.


Condition Intervention Phase
Leukemia, Lymphocytic, Acute, L2
Drug: Imatinib
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Dexamethasone
Drug: Methotrexate
Drug: Cytarabine
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Cytarabine    Cytarabine hydrochloride    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Methotrexate    Vincristine sulfate    Vincristine    Imatinib    Imatinib mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn if intensive chemotherapy, with imatinib mesylate (Gleevec, STI571) , followed by maintenance imatinib mesylate plus chemotherapy, followed by imatinib mesylate can improve Philadelphia-positive acute lymphoblastic leukemia. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of this treatment will also be studied. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Enrollment:   54
Study Start Date:   March 2001
Estimated Study Completion Date:   July 2015
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Hyper-CVAD + Imatinib
Drug: Imatinib
Imatinib 600mg PO
Drug: Cyclophosphamide
Cyclophosphamide 300mg/m2
Drug: Doxorubicin
Doxorubicin 50mg/m2
Drug: Vincristine
Vincristine 2mg
Drug: Dexamethasone
Dexamethasone 40mg
Drug: Methotrexate
Methotrexate 200mg/m2
Drug: Cytarabine
Cytarabine 3gm/m2

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion:

  • Diagnosis of previously untreated Ph-positive ALL or previously treated in CR after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.
  • Age > or = 15 years. Those < 15 years of age will be treated under compassionate IND.
  • Zubrod performance status < or = 2 (ECOG Scale, Appendix A).
  • Adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).
  • Adequate cardiac function as assessed clinically by physical examination.
  • Signed informed consent.

Exclusion:

  • Active serious infection not controlled by oral or intravenous antibiotics.
  • Treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening.
  • Active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.
  • History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
  • Prior history of treatment with imatinib mesylate.
  • Pregnancy or lactating in women of childbearing potential.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038610

Locations
United States, Texas
MD Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis

Investigators
Principal Investigator:     Susan O'Brien, M.D.     M.D. Anderson Cancer Center    
  More Information


M.D. Anderson's website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   University of Texas - MD Anderson Cancer Center ( Susan O'Brien, MD, BA, Professor )
Study ID Numbers:   ID01-006
First Received:   June 3, 2002
Last Updated:   July 28, 2008
ClinicalTrials.gov Identifier:   NCT00038610
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive  

Study placed in the following topic categories:
Dexamethasone
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Vincristine
Cyclophosphamide
Doxorubicin
Folic Acid
Imatinib
Leukemia
Lymphatic Diseases
Hyperkinesis
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Dexamethasone acetate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Protein Kinase Inhibitors
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
Immunosuppressive Agents
Antiviral Agents

ClinicalTrials.gov processed this record on October 10, 2008




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