NCT00030394

Brief Summary

This phase II trial is studying imatinib mesylate to see how well it works in treating patients with chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2002

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

5.1 years

First QC Date

February 14, 2002

Last Update Submit

January 16, 2013

Conditions

Childhood Chronic Myelogenous LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (3)

  • Response rate

    Up to 5 years

  • Disease-free survival

    Up to 5 years

  • Toxicities graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Up to 5 years

Secondary Outcomes (2)

  • Time to achieve hematological cytogenetic and molecular response

    Up to 12 months

  • Event free survival

    Up to 5 years

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

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.

Drug: imatinib mesylateOther: laboratory biomarker analysisOther: pharmacological study

Interventions

imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (imatinib mesylate)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (imatinib mesylate)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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
  • +47 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

Related Publications (1)

  • Champagne MA, Fu CH, Chang M, Chen H, Gerbing RB, Alonzo TA, Cooley LD, Heerema NA, Oehler V, Wood C, French ME, Arceci RJ, Smith FO, Bernstein ML. Higher dose imatinib for children with de novo chronic phase chronic myelogenous leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jul 15;57(1):56-62. doi: 10.1002/pbc.23031. Epub 2011 Apr 4.

    PMID: 21465636DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Martin Champagne

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

October 1, 2007

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)