LeukemiaNCT00386373
Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients
A study testing Imatinib Mesylate in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+) CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Imatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Oct 2007
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Ph(+) CML and/or CML with bcr-abl rearrangement and diploid cytogenetics not eligible for protocols of higher priority (e.g. ID02-901, DM99-081, DM97-206, etc).
- The disease must be beyond first chronic phase according to IBMTR criteria (i.e. accelerated phase, blastic phase, second chronic phase) at the time of transplant.
- Patients with Ph(+) acute lymphocytic (or myeloid) leukemia.
- Patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible.
- Age >/= 16 years
- Unsupported ANC at least 1500 and unsupported platelet count of at least 50K following BMT.
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- Patients may have received prior chemotherapy for their disease or be previously untreated.
- Patients must have received an allogeneic bone marrow or stem cell transplant. Allogeneic transplant types may include matched sibling donors, mismatched related donors, or unrelated donors. All preparative regimens acceptable.
- Signed informed consent
- Zubrod status </= 3
- Adequate hepatic (bilirubin </= 3 mg/dl, transaminases < 4 x upper limit of normal) and renal function (serum creatinine </= 3 mg/dl )
Who cannot join
- Grade III/IV cardiac problems as defined by the NYHAC
- History of hypersensitivity to imatinib
- Pregnant and lactating women
- HIV positive
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Use and Tolerability of Imatinib Mesylate (Gleevec®) in Patients With Philadelphia-Positive Chronic Myeloid or Acute Leukemia During the First 100 Days Following Bone Marrow or Stem Cell Transplantation
Primary Objective:
- To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+) CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation.
Secondary Objectives:
- To identify any clinically significant drug interactions with imatinib in the post-transplant setting.
- To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting.
- To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint.
Read the detailed description
Imatinib mesylate is an FDA-approved, commercially available drug for patients with acute or chronic leukemias carrying the Philadelphia chromosome. Women who are able to have children must have a negative blood pregnancy test before taking this drug
No earlier than three weeks after the bone marrow or stem cell transplant, you will start taking imatinib mesylate by mouth. You will take it once or twice a day until roughly 100 days following the transplant or until you are released from the Houston area by your M. D. Anderson physician. Imatinib mesylate should be taken with a meal and a glass of water, preferably in the morning.
The dose will be gradually increased as long as you don't experience severe side effects. If severe side effects occur, imatinib will be stopped, either temporarily or permanently.
After about 100 days (or after leaving Houston) the medication may be continued at the discretion of the study doctor, but the study will be considered completed.
This is an investigational study. A total of up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson. The study is partially funded by the manufacturer of imatinib mesylate (see below), although the drug is not provided free of charge.
- Conditions
- Leukemia
- Being tested
- Imatinib Mesylate
- Keywords
- Chronic Myeloid Leukemia, CML, ALL, AML, Leukemia, Imatinib Mesylate, Gleevec, Philadelphia-Positive, Bone marrow transplant, BMT, Stem cell transplant, SCT
- Medical subject headings
- Leukemia, 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.
Imatinib MesylateDrug
Also called Gleevec, Imatinib, STI571, NSC-716051
Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Mesylate | Experimental | Not described Receives: Drug: Imatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Rate
Measured: 100 Days and 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startAug 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Anderlini, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386373
- Sponsor's protocol ID
- 2003-0433
- Status last verified
- Jul 2012
- First submitted
- 9 Oct 2006
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Tolerability of Imatinib Mesylate (Gleevec®) in Patients With Philadelphia-Positive Chronic Myeloid or Acute Leukemia During the First 100 Days Following Bone Marrow or Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00386373
- Acronym / sponsor ID
- 2003-0433
- Conditions
- Leukemia
- Keywords
- Chronic Myeloid Leukemia, CML, ALL, AML, Leukemia, Imatinib Mesylate, Gleevec, Philadelphia-Positive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Oct 2006 (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.
Primary Objective:
- To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+) CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation.
Secondary Objectives:
- To identify any clinically significant drug interactions with imatinib in the post-transplant setting.
- To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting.
- To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint.
Detailed description
Imatinib mesylate is an FDA-approved, commercially available drug for patients with acute or chronic leukemias carrying the Philadelphia chromosome. Women who are able to have children must have a negative blood pregnancy test before taking this drug
No earlier than three weeks after the bone marrow or stem cell transplant, you will start taking imatinib mesylate by mouth. You will take it once or twice a day until roughly 100 days following the transplant or until you are released from the Houston area by your M. D. Anderson physician. Imatinib mesylate should be taken with a meal and a glass of water, preferably in the morning.
The dose will be gradually increased as long as you don't experience severe side effects. If severe side effects occur, imatinib will be stopped, either temporarily or permanently.
After about 100 days (or after leaving Houston) the medication may be continued at the discretion of the study doctor, but the study will be considered completed.
This is an investigational study. A total of up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson. The study is partially funded by the manufacturer of imatinib mesylate (see below), although the drug is not provided free of charge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib Mesylate | Experimental | Drug: Imatinib Mesylate |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with Ph(+) CML and/or CML with bcr-abl rearrangement and diploid cytogenetics not eligible for protocols of higher priority (e.g. ID02-901, DM99-081, DM97-206, etc).
- The disease must be beyond first chronic phase according to IBMTR criteria (i.e. accelerated phase, blastic phase, second chronic phase) at the time of transplant.
- Patients with Ph(+) acute lymphocytic (or myeloid) leukemia.
- Patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible.
- Age >/= 16 years
Key exclusion criteria (4 listed)
- Grade III/IV cardiac problems as defined by the NYHAC
- History of hypersensitivity to imatinib
- Pregnant and lactating women
- HIV positive
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 |
|---|---|---|
| Imatinib MesylateAlso: Gleevec, Imatinib, STI571, NSC-716051Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT). | Drug | Imatinib Mesylate |
Primary outcome
Toxicity Rate
Time frame: 100 Days and 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Paolo Anderlini, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imatinib Mesylate in people with Leukemia, run by M.D. Anderson Cancer Center 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 11 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: finished, as of the sponsor's last update on 1 Aug 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity Rate (time frame: 100 Days and 1 Year). 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 1 Aug 2012.