Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer Leukemia, Other

Outcome Measures

Primary Outcomes (1)

To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease
2 years

Secondary Outcomes (1)

To determine the toxicity associated with this therapy
2 years

Interventions

Gleevec and Arsenic TrioxideDrug

Pts. who fit the inclusion criteria, \& were on imatinib, 400 mg/day, will be treated with a month of imatinib at 800 mg/d in divided doses (400mg bid) \& then started on arsenic trioxide. Pts. already on imatinib 800 mg/day may be started on arsenic trioxide. Pts. unable to tolerate 800 mg/d should be treated at the max. dose tolerated above 400 mg/d. A total of 16 weeks of arsenic trioxide treatment will be administered (15 weeks of maintenance). Pts. are to continue on imatinib 800 mg/day,(or the max. tolerated dose) while receiving the arsenic trioxide. If a pt. has been taken off the arsenic trioxide, they should be continued on gleevec 800 mg per day (or the maximum tolerated dose) until there is evidence of progression of disease.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All patients, 18 years of age or older, with a diagnosis of CML.
Patients must have a life expectancy of at least 12 weeks.

Sponsors & Collaborators

New Mexico Cancer Research Alliance
Otherlead

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

MeSH Terms

Conditions

LeukemiaNeoplasms

Interventions

Imatinib MesylateArsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic Acids

Study Officials

Ian Rabinowitz, MD
University of New Mexico
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

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

November 3, 2005

First Posted

November 7, 2005

Study Start

April 2004

Date type not reported

This date has not been verified as actual or estimated.

A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations