NCT00015834

Brief Summary

Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

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

May 1, 2001

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

May 6, 2001

Last Update Submit

January 23, 2013

Conditions

Blastic Phase Chronic Myelogenous LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveRelapsing Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (3)

  • Toxicity according to NCI/NIH Common Toxicity Criteria

    Described by duration, relatedness to treatment, and action taken.

    Up to 2 years

  • Hematologic response

    Up to 6 months

  • Bone marrow cytogenetic response

    Up to 6 months

Study Arms (1)

Treatment (imatinib mesylate, cytarabine)

EXPERIMENTAL

Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylateDrug: cytarabine

Interventions

imatinib mesylateDRUG

Given PO

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate, cytarabine)
cytarabineDRUG

Given IV

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside
Treatment (imatinib mesylate, cytarabine)

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of chronic myelogenous leukemia in myeloid blast crisis
  • At least 30% blasts in bone marrow
  • Philadelphia chromosome positive by cytogenetic analysis
  • bcr/abl translocation by fluorescent in situ hybridization
  • Ineligible for or refused allogeneic stem cell transplantation
  • Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart
  • Performance status - ECOG 0-2
  • See Disease Characteristics
  • Bilirubin less than 3 times upper limit of normal (ULN)
  • AST and ALT less than 3 times ULN
  • Creatinine less than 2 times ULN
  • No New York Heart Association class III or IV heart disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Los Angeles (UCLA )

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Blast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib MesylateCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesCytidinePyrimidine NucleosidesArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Ronald Paquette

    University of California at Los Angeles (UCLA )

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2001

First Posted

January 27, 2003

Study Start

May 1, 2001

Primary Completion

April 1, 2003

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)