NCT00045422

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining interferon alfa with imatinib mesylate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with imatinib mesylate in treating patients who have chronic myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.5 years

First QC Date

September 6, 2002

Last Update Submit

June 4, 2013

Conditions

Leukemia

Keywords

chronic myelogenous leukemia, BCR-ABL1 positivechronic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemia

Interventions

recombinant interferon alfaBIOLOGICAL
imatinib mesylateDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of chronic phase chronic myelogenous leukemia * Cytogenetically confirmed Philadelphia chromosome-positive disease or other variant of t(9;22) * No secondary chromosomal abnormalities * No more than 10% blasts in bone marrow * Newly diagnosed OR * Received prior imatinib mesylate as a single agent for no more than the past 9 months without achieving a complete cytogenetic response * No evidence of extramedullary involvement except nodes, liver, or spleen PATIENT CHARACTERISTICS: Age * Any age Performance status * ECOG 0-3 Life expectancy * Not specified Hematopoietic * Platelet count greater than 100,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT no greater than 2 times ULN * INR no greater than 1.5 times ULN\* * PTT no greater than 1.5 times ULN\* NOTE: \* Except patients on anticoagulants Renal * Creatinine no greater than 2 times ULN Other * Considered potentially reliable * No history of noncompliance to medical regimens * No other active malignancy requiring chemotherapy or radiotherapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier-method contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interferon therapy * No prior stem cell or bone marrow transplantation Chemotherapy * No prior chemotherapy (except hydroxyurea and/or anagrelide to control counts) Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * At least 4 weeks since prior major surgery and recovered Other * No concurrent grapefruit juice or grapefruit products * No concurrent warfarin * Concurrent low-molecular weight heparin allowed

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

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

Interventions

Interferon-alphaImatinib 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)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Ellin Berman, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)