NCT00054431

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

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

January 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

February 5, 2003

Last Update Submit

January 22, 2013

Conditions

Accelerated Phase Chronic Myelogenous LeukemiaBlastic Phase Chronic Myelogenous LeukemiaChildhood Chronic Myelogenous LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveRelapsing Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (3)

  • Complete and partial response

    6 months

  • Hematologic improvement

    Up to 1 year

  • Duration of response

    Date of documented response until relapse, assessed up to 4 years

Secondary Outcomes (1)

  • Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Up to 4 years

Study Arms (1)

Treatment (imatinib mesylate, decitabine)

EXPERIMENTAL

Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylateDrug: decitabineOther: laboratory biomarker analysis

Interventions

imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate, decitabine)
decitabineDRUG

Given IV

Also known as: 5-aza-dCyd, 5AZA, DAC
Treatment (imatinib mesylate, decitabine)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (imatinib mesylate, decitabine)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed chronic myelogenous leukemia
  • Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
  • Accelerated or non-lymphoid blastic phase
  • Performance status - ECOG 0-2
  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 2 times ULN
  • Creatinine less than 2.0 mg/dL
  • Normal cardiac function
  • No New York Heart Association class III or IV heart disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior decitabine
  • At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
  • Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib MesylateDecitabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesAzacitidineAza CompoundsCytidinePyrimidine NucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Jean-Pierre Issa

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

January 1, 2003

Primary Completion

May 1, 2007

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)