Full Text View
Tabular View
No Study Results Posted
Related Studies
Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
This study has been completed.
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030394
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This phase II trial is studying imatinib mesylate to see how well it works in treating patients with chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Gleevec in Ph+ Chronic Phase Chronic Myelogenous Leukemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Toxic effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of hematological, cytogenetic, and molecular responses at 3, 6, and 12 months [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: September 2002
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with Philadelphia chromosome positive chronic phase chronic myelogenous leukemia treated with imatinib mesylate.
  • Determine the disease-free survival of patients treated with this drug.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the toxic effects of this drug in these patients.
  • Determine the rates of hematological, cytogenetic, and molecular response and time to response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients are stratified according to disease (chronic myelogenous leukemia [CML] in first chronic phase after failing interferon therapy or demonstrating intolerance to interferon [closed to accrual as of 12/05/03] vs CML relapsing after stem cell transplantation or in second or subsequent chronic phase [closed to accrual as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior treatment [closed to accrual as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior treatment).

Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve a complete hematologic response after 3 courses or a partial or complete cytogenic response after 6 courses are removed from the study.

PROJECTED ACCRUAL: A total of 109 patients (30 for stratum I [closed to accrual as of 12/05/03] and stratum II [closed to accrual as of 7/29/05], 34 for stratum III [closed to accrual as of 7/29/05], and 45 for stratum IV) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Philadelphia chromosome positive (Ph+) chronic phase chronic myelogenous leukemia (CML)
  • Stratum I (closed to accrual as of 12/05/03):

    • CML in first chronic phase with resistance to interferon alfa (IFN-A) therapy defined as one of the following:

      • WBC count at least 20,000/mm^3 after at least 3 months of treatment with an IFN-A-containing regimen
      • Rising WBC count (at least 100% increase to a level of at least 20,000/mm^3) by two samples at least two weeks apart while receiving treatment with an IFN-A-containing regimen
      • At least 66% Ph+ cells in bone marrow after 1 year of IFN-A therapy
      • At least 30% increase in Ph+ cells in bone marrow after IFN-A-induced cytogenetic response while continuing to receive IFN-A therapy OR
    • Intolerance to interferon therapy defined as more than two grade 2 toxic effects or any grade 3 toxic effect related to interferon therapy, except grade 3 fever, that is persistent beyond the first 28-day course of therapy and unresponsive to standard supportive care interventions
  • Stratum II (closed to accrual as of 7/29/05): CML recurring after stem cell transplantation or in second or subsequent chronic phase

    • No molecular relapse (only evidence is detection of bcr-abl rearrangement with normal bone marrow and blood morphology and normal standard cytogenetic analysis)
  • Stratum III (closed to accrual as of 7/29/05): Newly diagnosed CML in first chronic phase with no prior treatment except hydroxyurea
  • Stratum IV: Newly diagnosed CML in first chronic phase with no prior treatment except hydroxyurea
  • No accelerated or blast phase defined as one or more of the following:

    • WBC doubling time less than 5 days
    • Chloroma
    • Medullary fibrosis
    • More than 10% blasts in peripheral blood or bone marrow
    • More than 20% promyelocytes in peripheral blood or bone marrow
    • More than 20% basophils and eosinophils in peripheral blood

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • See Disease Characteristics
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • ALT less than 3.0 times normal
  • Albumin greater than 2 g/dL

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • No CNS toxicity greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior immunotherapy (for patients in stratum III [closed to accrual as of 7/29/05] and stratum IV only)
  • At least 3 months since prior stem cell transplantation (SCT) (patients with allogeneic SCT must have no active graft-versus-host disease [GVHD] and have stable use of steroids) (for patients in stratum II only )
  • At least 1 week since prior growth factors
  • At least 1 week since prior biologic therapy, including interferon alfa (for patients in stratum I [closed to accrual as of 12/05/03] and stratum II only)
  • Recovered from prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • See Disease Characteristics
  • No prior chemotherapy (for patients in stratum III [closed to accrual as of 7/29/05] and stratum IV only)
  • At least 6 weeks since prior busulfan or nitrosoureas
  • At least 7 days since prior hydroxyurea
  • At least 7 days since prior low-dose cytarabine (less than 30 mg/m^2 every 12 to 24 hours)
  • At least 14 days since prior moderate-dose cytarabine (100-200 mg/m^2 for 5 to 7 days)
  • At least 28 days since prior high-dose cytarabine (1-3 g/m^2 every 12 to 24 hours for 6 to 12 doses)
  • At least 21 days since all other cytotoxic chemotherapy
  • Recovered from prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent steroids other than for controlled GVHD in patients with prior allogeneic SCT

Radiotherapy:

  • No prior radiotherapy (for patients in stratum III [closed to accrual as of 7/29/05] and stratum IV only)
  • At least 2 weeks since prior local palliative (small port) radiotherapy*
  • At least 3 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of pelvis*
  • At least 6 weeks since prior substantial bone marrow radiotherapy*
  • Recovered from prior radiotherapy NOTE: * For patients in stratum I (closed to accrual as of 12/05/03) and stratum II only

Surgery:

  • Not specified

Other:

  • No prior imatinib mesylate
  • No concurrent enzyme-activating anticonvulsants
  • No concurrent warfarin
  • No concurrent naturopathic agents or herbal medicines
  • No other concurrent investigational agents
  • Concurrent low-molecular weight heparin allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030394

  Show 97 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Martin Champagne, MD Hopital Sainte Justine
  More Information

Additional Information:
Publications:
Champagne MA, Fu C, Chang M, et al.: Imatinib in children with newly diagnosed chronic phase chronic myelogenous leukemia (CP CML): AAML0123 COG study. [Abstract] Blood 108 (11): A-2140, 2006.

Study ID Numbers: CDR0000069161, COG-AAML0123
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030394     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
childhood chronic myelogenous leukemia

Study placed in the following topic categories:
Imatinib
Philadelphia Chromosome
Leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases
Protein Kinase Inhibitors

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009