Chronic Myelogenous LeukemiaPhase 2NCT01011998
A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
A Phase 2 study testing Gleevec (imatinib), valproic acid in people with Chronic Myelogenous Leukemia, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- Gleevec (imatinib), valproic acid
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- Gleevec (imatinib), valproic acid
- Keywords
- CML, Chronic Myelogenous leukemia, INST 0901, imatinib, valproic acid, Gleevec
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gleevec (imatinib), valproic acidDrug
Also called Valproic acid, Imatinib, Gleevec
Valproic acid: 250 mg three times per day and then adjusted according to attain a therapeutic level.
Gleevec will be continued at the dose the patient was taking at the time of entry onto the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJul 2010
Why it stopped: Withdrawn due to lack of accrual per Center DSMP, with PI concurrence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Rabinowitz, MD, Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011998
- Sponsor's protocol ID
- INST 0901
- Status last verified
- Jul 2011
- First submitted
- 5 Nov 2009
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Imatinib and Valproic Acid in Patients With CML
- ClinicalTrials.gov ID
- NCT01011998
- Acronym / sponsor ID
- INST 0901
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- CML, Chronic Myelogenous leukemia, INST 0901, imatinib, valproic acid, Gleevec
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of accrual per Center DSMP, with PI concurrence
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gleevec (imatinib), valproic acidAlso: Valproic acid, Imatinib, GleevecValproic acid: 250 mg three times per day and then adjusted according to attain a therapeutic level. Gleevec will be continued at the dose the patient was taking at the time of entry onto the study. | Drug | – |
Primary outcome
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.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Rabinowitz, MD principal investigator
University of New Mexico Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gleevec (imatinib), valproic acid in people with Chronic Myelogenous Leukemia, run by New Mexico Cancer Research Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.