NCT00041990

Brief Summary

To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

8 active sites

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

July 1, 2002

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2002

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

July 19, 2002

Last Update Submit

December 12, 2007

Conditions

Chronic Myelogenous Leukemia

Keywords

Chronic myelogenous leukemiaCMLCML-APAccelerated phaseDecitabine5-aza-2'deoxycytidineMethylationSTI 571Imatinib mesylateGleevecBCR/ABL

Interventions

decitabine (5-aza-2'deoxycytidine)DRUG

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of CML accelerated phase
  • Ph chromosome-positive
  • Previous treatment with imatinib mesylate resulting in:
  • i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
  • Patients must have recovered from the side effects of previous CML therapy for accelerated phase with the exception of hydroxyurea
  • Age \>/= 2 years
  • Bilirubin \</= 3 x the upper limit of normal (ULN), SGOT and SGPT \</= 3 x ULN, except \</= 5 x ULN in leukemic involvement of the liver, serum creatinine \</= 2 x ULN
  • WHO performance status 0-3
  • A negative serum hCG pregnancy test in patients of childbearing potential
  • Able to give signed informed consent directly or through a parent or guardian for minors

You may not qualify if:

  • Leukemic involvement of the central nervous system
  • Active malignancy other than CML or non-melanoma cancer of the skin
  • Previous treatment for CML with another investigational agent within 28 days of study entry
  • At study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
  • Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
  • Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
  • Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
  • Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
  • Patients with systemic, uncontrolled infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

City of Hope Medical Center

Duarte, California, United States

Location

Scripps Clinic

Escondido, California, United States

Location

USC/Norris Cancer Center

Los Angeles, California, United States

Location

Metro-Minnesota CCOP

Saint Louis Park, Minnesota, United States

Location

New York Medical College

Valhalla, New York, United States

Location

Liberty Hematology/Oncology

Columbia, South Carolina, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 19, 2002

First Posted

July 23, 2002

Study Start

July 1, 2002

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

US(7)CA(1)