NCT00250042

Brief Summary

1.0 OBJECTIVES 1.1 To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease. 1.2 To determine the toxicity associated with this therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

2 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

April 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

September 20, 2011

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

November 3, 2005

Last Update Submit

September 18, 2011

Conditions

Leukemia, OtherCancer

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.

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.
  • Patients must have an ECOG performance status of 0-2.
  • Patients must sign an informed consent.
  • Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
  • Patients with CML in chronic phase on gleevec as first line therapy who fulfill the following criteria:
  • Failure to achieve a complete hematologic response (CHR) after 3 months of therapy (hematologic resistance)
  • Failure to achieve a complete cytogenetic response (CGCR) after \> 9 months of therapy.
  • Cytogenetic relapse, defined as an increase in the Ph+ cells by at least 30%.
  • Hematologic relapse defined as the appearance of any of the following, confirmed by a second determination \> 1 month later:
  • WBC count \>20, 000,
  • Platelet count \>600,000,
  • Progressive splenomegaly \> 5 cm below the left intercostals margin,
  • \>5% myelocytes and/or metamyelocytes in the peripheral blood,
  • Blasts or promyelocytes in the peripheral blood

You may not qualify if:

  • Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
  • Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
  • Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

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 AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Ian Rabinowitz, MD

    University of New Mexico

    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

November 3, 2005

First Posted

November 7, 2005

Study Start

April 1, 2004

Primary Completion

April 1, 2005

Study Completion

March 1, 2006

Last Updated

September 20, 2011

Record last verified: 2009-12

Locations

US(2)