NCT00038597

Brief Summary

The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2001

Typical duration 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

April 30, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2004

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

June 3, 2002

Last Update Submit

October 29, 2018

Conditions

Myelogenous Leukemia, Chronic

Keywords

Philadelphia chromosome positive CMLMyelogenous Leukemia, Chronic, Chronic PhaseMyelogenous Leukemia, Chronic, Accelerated Phase

Interventions

SCH66336DRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase; * Failure to respond to or intolerance to imatinib mesylate (Gleevec); * Age \>/= 16 years; * Life expectancy of \>/= 2 months; * Performance status 2 or better (Zubrod); * Adequate renal and hepatic functions (creatinine and bilirubin \</= 2 mg/dl); * Adequate cardiac function; * Not candidates for or have refused allogeneic transplantation; * Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.

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

Sponsors & Collaborators

Study Sites (1)

MDAnderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-PhaseLeukemia, MyeloidBronchiolitis Obliterans Syndrome

Interventions

lonafarnib

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Jorge Cortes, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 3, 2002

First Posted

June 4, 2002

Study Start

April 30, 2001

Primary Completion

May 7, 2004

Study Completion

May 7, 2004

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

US(1)