NCT00022490

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

2 active sites

Status
terminated

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

June 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 11, 2012

Completed
Last Updated

January 7, 2016

Status Verified

December 1, 2015

Enrollment Period

9.9 years

First QC Date

August 10, 2001

Results QC Date

June 6, 2012

Last Update Submit

December 8, 2015

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (1)

  • The Rate of Major Cytogenetic Response at 6 Months

    Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.

    6 months

Secondary Outcomes (4)

  • The Rate of Complete Cytogenetic Response at 6 Months

    6 months

  • The Rate of Complete and Major Cytogenetic Responses at 12 Months

    12 months

  • The Rate of Minor Cytogenetic Responses at 6 and 12 Months

    6 and 12 months

  • The Rate of Complete Hematologic Responses at 6 and 12 Months

    6 and 12 months

Study Arms (1)

Cytarabine/ Imatinib Mesylate

EXPERIMENTAL
Drug: cytarabineDrug: imatinib mesylate

Interventions

cytarabineDRUG

Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle

Cytarabine/ Imatinib Mesylate
imatinib mesylateDRUG

Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.

Cytarabine/ Imatinib Mesylate

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML) * Less than 15% blasts in peripheral blood or bone marrow * Less than 30% blasts and promyelocytes in peripheral blood or bone marrow * Less than 20% basophils in blood or bone marrow * Platelet count at least 100,000/mm\^3 * Philadelphia chromosome positive * No more than 6 months since initial diagnosis * No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e., chloroma) * Refused allogeneic stem cell transplantation as first-line therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 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 3 months after study participation * No other serious uncontrolled medical condition * No history of noncompliance to medical regimens or potential unreliability PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior biologic therapy for CML Chemotherapy: * No prior chemotherapy for CML except hydroxyurea * Concurrent hydroxyurea to control blood counts during first 3 months of treatment allowed * No other concurrent chemotherapy Endocrine therapy: * No prior endocrine therapy for CML Radiotherapy: * No prior radiotherapy for CML Surgery: * Not specified Other: * More than 28 days since prior investigational anticancer agents * Prior anagrelide hydrochloride for CML allowed * Concurrent anagrelide hydrochloride to control blood counts during first 3 months of treatment allowed * No concurrent grapefruit juice or grapefruit

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

Sponsors & Collaborators

Study Sites (2)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

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

Interventions

CytarabineImatinib 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)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazines

Limitations and Caveats

Study was terminated, therefore the 12 month response data was not analyzed.

Results Point of Contact

Title
Dr. Brian Druker
Organization
OHSU Knight Cancer Institute
drukerb@ohsu.edu
(503) 494 5596

Study Officials

  • Brian J. Druker, MD

    OHSU Knight Cancer Institute

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

January 7, 2016

Results First Posted

July 11, 2012

Record last verified: 2015-12

Locations

US(2)