NCT00136409

Brief Summary

The purpose of this study is to determine the effects (good and bad) of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2002

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

May 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

3.3 years

First QC Date

August 25, 2005

Last Update Submit

December 22, 2016

Conditions

MyelofibrosisMyeloid MetaplasiaAgnogenic Myeloid MetaplasiaChronic Myelomonocytic Leukemia

Keywords

myelofibrosisagnogenic myeloid metaplasia with myelofibrosisCMMLchronic myelomonocytic leukemiaimatinib mesylateGleevec

Outcome Measures

Primary Outcomes (1)

  • To determine the overall response rate of Gleevec as a single agent in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia

    3 years

Secondary Outcomes (2)

  • To determine the safety and efficacy of Gleevec as a single agent in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia

    3 years

  • to determine the biologic activity of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia

    3 years

Study Arms (1)

Mono-Therapy Gleevec

EXPERIMENTAL

Gleevec administered orally at a pre-determined dose once daily.

Drug: Imatinib mesylate

Interventions

Imatinib mesylateDRUG

400mg orally once daily until disease progression or unacceptable side effects

Also known as: Gleevec
Mono-Therapy Gleevec

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a clinical diagnosis of myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia (CMML). Patients may be entered based on a prior cytogenetic karyotype showing the absence of the Philadelphia chromosome.
  • Patients may be entered prior to completion of reverse transcription-polymerase chain reaction (RT-PCR) or fluorescent in situ hybridization (FISH) studies, but a patient who is subsequently found to be BCR-ABL or FISH positive will be removed from protocol treatment. FISH will only be performed on patients with a normal karyotype. A PCR sample will be sent on all patients.
  • The patients with myelodysplasia must have French-American-British (FAB) subtype chronic myelomonocytic leukemia (CMML) defined as peripheral blood monocytosis, and less than 30 percent blasts in the peripheral blood or the bone marrow.
  • The patients with myelofibrosis with myeloid metaplasia can have one of the following: agnogenic myeloid metaplasia (idiopathic myelofibrosis), or post-polycythemic myeloid metaplasia (post-polycythemic myelofibrosis), or post-thrombocythemic myeloid metaplasia.
  • Estimated life expectancy of 6 months or greater.
  • Serum bilirubin equal to or less than twice the upper limit of normal.
  • Serum SGOT and SGPT equal to or less than twice the upper limit of normal.
  • Serum creatinine equal to or less than twice the upper limit of normal.
  • Age at least 18 years.
  • Greater than 4 weeks from any chemotherapy (except hydroxyurea), radiotherapy, immunotherapy, or systemic glucocorticoid therapy (non-glucocorticoid hormonal therapy is allowed). Systemic glucocorticoid therapy for non-malignant disease is allowed.
  • The last dose of hydroxyurea must be 24 hours prior to the initiation of Gleevec.
  • Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (DLI).

You may not qualify if:

  • Uncontrolled active infection.
  • Pregnancy or nursing mothers.
  • Patients with myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia who have transformed to acute myelogenous leukemia.
  • Prior treatment or diagnosis of acute myelogenous leukemia.
  • Patients with Philadelphia positive cytogenetics by either peripheral blood or bone marrow sampling.
  • Eastern Cooperative Oncology Group (ECOG) performance status \> 3.
  • Prior exposure to Gleevec.
  • Active central nervous system (CNS) disease.
  • Evidence of infection with the human immunodeficiency virus.
  • Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Primary MyelofibrosisLeukemia, Myelomonocytic, Chronic

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyelodysplastic-Myeloproliferative DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Daniel J. DeAngelo, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

May 1, 2002

Primary Completion

August 1, 2005

Study Completion

December 1, 2008

Last Updated

December 23, 2016

Record last verified: 2016-12

Locations

US(2)