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A Phase II Study of Imatinib and Valproic Acid in Patients With CML


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

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Trial Information

A Phase II Study of Imatinib and Valproic Acid in Patients With CML


The aim of this study is to test the effect of the combination of valproate in combination
with imatinib with an aim of achieving a maximal molecular response as the primary goal.
Briefly, patients with CML who are taking imatinib and have been found to have a plateau in
their level of the bcr-abl transcript will be eligible to participate in the study.
Valproate will then be added to the imatinib, and subsequent bcr-abl transcripts will be
monitored to see if the addition of valproate produced a further reduction. Patients will be
monitored for efficacy and toxicity.


Inclusion Criteria:



- 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 imatinib as first line therapy who fulfill the
following criteria:

- The patient has at least two tests for quantitative reverse transcriptase polymerase
chain reaction (RT-PCR) for bcr-abl (peripheral blood or bone marrow aspirate). The
results of these tests should demonstrate a relative plateau in the effect of
imatinib on the detected level of the transcript (i.e. there should less than a ½ log
difference between the last two values). Note: Patients will be eligible if the more
recent study is greater than the previous study by any value.

- The last two quantitative RT-PCR studies should be at least 3 months apart.

- The patient should have received at least 9 months of imatinib since the diagnosis of
CML.

- The patient is tolerating imatinib without any grade 3 or greater toxicity.

Exclusion Criteria:

- 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.

- Patients who have a hypersensitivity to valproic acid, derivatives, or any component
of the formulation. Patients with hepatic disease or significant impairment, or urea
cycle disorders

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Ian Rabinowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

INST 0901

NCT ID:

NCT01011998

Start Date:

September 2009

Completion Date:

July 2010

Related Keywords:

  • Chronic Myelogenous Leukemia
  • CML
  • Chronic Myelogenous leukemia
  • INST 0901
  • imatinib
  • valproic acid
  • Gleevec
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636