Trials Sponsors Conditions Drugs Pricing

Conditions

Myelofibrosis Myeloid Metaplasia Agnogenic Myeloid Metaplasia Chronic 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.

Sponsors & Collaborators

Brigham and Women's Hospital
Othercollaborator
Massachusetts General Hospital
Othercollaborator
Novartis

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

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 Attributes

Study Officials

Daniel J. DeAngelo, MD, PhD
Dana-Farber Cancer Institute
PRINCIPAL INVESTIGATOR

Enrollment

34 participants (actual enrollment reported by the registry).

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 2002

Date type not reported

This date has not been verified as actual or estimated.

A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Mono-Therapy Gleevec

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Mono-Therapy Gleevec

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations