NCT00006053

Brief Summary

RATIONALE: STI571 may interfere with the growth of cancer cells and may be effective treatment for chronic myelogenous leukemia. PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have chronic myeloid leukemia that has not responded to interferon alfa.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2000

Shorter than P25 for phase_2 leukemia

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 4, 2004

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

2.7 years

First QC Date

July 5, 2000

Last Update Submit

January 16, 2013

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiachronic myelogenous leukemia, BCR-ABL1 positivePhiladelphia chromosome negative chronic myelogenous leukemia

Interventions

imatinib mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myelogenous leukemia (CML) Philadelphia (Ph) chromosome positive OR Bcr/Abl positive Refractory to or intolerant of interferon alfa therapy Failure to achieve complete response for at least 1 month after at least 6 months of interferon alfa therapy OR At least 65% Ph chromosome positivity in bone marrow after at least 1 year of interferon alfa therapy OR At least 30% increase in Ph chromosome positive bone marrow cells in samples taken at least 1 month apart or increase to at least 65% while receiving interferon alfa therapy OR At least 100% increase in WBC count to at least 20,000/mm3 in samples taken at least 2 weeks apart while receiving interferon alfa therapy OR At least grade 3 nonhematologic toxicity persisting for more than 2 weeks while receiving interferon alfa therapy (must be more than 3 months from time of diagnosis) No greater than 15% blasts or basophils in peripheral blood or bone marrow Less than 30% blasts plus promyelocytes in peripheral blood or bone marrow PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for women and at least 3 months after study for men No history of noncompliance to prior medical regimens PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 14 days since prior interferon alfa No other concurrent biologic therapy Chemotherapy: At least 6 weeks since prior busulfan At least 14 days since prior cytarabine At least 7 days since prior hydroxyurea No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 28 days since prior investigational agents No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, 07936, United States

Location

Related Publications (2)

  • Hensley ML, van Hoomissen IC, Krahnke T, et al.: Imatinib in chronic myeloid leukemia (CML): outcomes in >7000 patients treated on expanded access program (EAP). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2328, 2003.

    RESULT

  • van Hoomissen IC, Hensley ML, Krahnke T, et al.: Imatinib expanded access program (EAP): results of treatment in >7000 patients with chronic myeloid leukemia (CML). [Abstract] Blood 102 (11): A-3370, 2003.

    RESULT

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ilana Monteleone

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

May 4, 2004

Study Start

June 1, 2000

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)