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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.
First Received: June 3, 2002   Last Updated: July 28, 2008   History of Changes
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
Drug Information available for: Dexamethasone Cyclophosphamide Vincristine Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Myocet Imatinib Imatinib mesylate Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate
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

  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

Additional Information:
No publications provided

Responsible Party: University of Texas - MD Anderson Cancer Center ( Susan O'Brien, MD, BA, Professor )
Study ID Numbers: ID01-006
Study First Received: June 3, 2002
Last Updated: July 28, 2008
ClinicalTrials.gov Identifier: NCT00038610     History of Changes
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:
Anti-Inflammatory Agents
Dexamethasone
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cyclophosphamide
Protein Kinase Inhibitors
Hormones
Anti-Bacterial Agents
Leukemia
Hyperkinesis
Methotrexate
Lymphoma
Alkylating Agents
Dexamethasone acetate
Cytarabine
Acute Lymphoblastic Leukemia
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Vincristine
Antimitotic Agents
Folic Acid Antagonists
Glucocorticoids
Immunosuppressive Agents
Antiviral Agents
Doxorubicin

Additional relevant MeSH terms:
Dexamethasone
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protein Kinase Inhibitors
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Imatinib
Neoplasms
Antineoplastic Agents, Phytogenic
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 07, 2009