LeukemiaPhase 2NCT00022490
Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
A Phase 2 study testing cytarabine and imatinib mesylate in people with Leukemia, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Leukemia
- What is being tested?
- cytarabine and imatinib mesylate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2001to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML)
- Less than 15% blasts in peripheral blood or bone marrow
- Less than 30% blasts and promyelocytes in peripheral blood or bone marrow
- Less than 20% basophils in blood or bone marrow
- Platelet count at least 100,000/mm^3
- Philadelphia chromosome positive
- No more than 6 months since initial diagnosis
- No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e., chloroma)
- Refused allogeneic stem cell transplantation as first-line therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
- No other serious uncontrolled medical condition
- No history of noncompliance to medical regimens or potential unreliability
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior biologic therapy for CML
Chemotherapy:
- No prior chemotherapy for CML except hydroxyurea
- Concurrent hydroxyurea to control blood counts during first 3 months of treatment allowed
- No other concurrent chemotherapy
Endocrine therapy:
- No prior endocrine therapy for CML
Radiotherapy:
- No prior radiotherapy for CML
Surgery:
- Not specified
Other:
- More than 28 days since prior investigational anticancer agents
- Prior anagrelide hydrochloride for CML allowed
- Concurrent anagrelide hydrochloride to control blood counts during first 3 months of treatment allowed
- No concurrent grapefruit juice or grapefruit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
Read the detailed description
OBJECTIVES:
- Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine.
- Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen.
- Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30-60 days.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- cytarabine, imatinib mesylate
- Keywords
- chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase, 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.
cytarabineDrug
Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
imatinib mesylateDrug
Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Cytarabine/ Imatinib Mesylate | Experimental | Not described Receives: Drug: cytarabine; Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Major Cytogenetic Response at 6 Months
Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
Measured: 6 months
Secondary outcomes (4)
The Rate of Complete Cytogenetic Response at 6 Months
Measured: 6 months
The Rate of Complete and Major Cytogenetic Responses at 12 Months
Measured: 12 months
The Rate of Minor Cytogenetic Responses at 6 and 12 Months
Measured: 6 and 12 months
The Rate of Complete Hematologic Responses at 6 and 12 Months
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian J. Druker, MD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022490
- Sponsor's protocol ID
- CDR0000068822
- Other IDs
- OHSU-NCI-4653, OHSU-1184, OHSU-HEM-01017-LX, NCI-4653
- Status last verified
- Dec 2015
- First submitted
- 10 Aug 2001
- Last updated
- 7 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
- ClinicalTrials.gov ID
- NCT00022490
- Acronym / sponsor ID
- CDR0000068822
- Conditions
- Leukemia
- Keywords
- chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 11 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
Detailed description
OBJECTIVES:
- Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine.
- Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen.
- Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30-60 days.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytarabine/ Imatinib Mesylate | Experimental | Drug: cytarabine, Drug: imatinib mesylate |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cytarabineOnce daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle | Drug | Cytarabine/ Imatinib Mesylate |
| imatinib mesylateOnce daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months. | Drug | Cytarabine/ Imatinib Mesylate |
Primary outcome
The Rate of Major Cytogenetic Response at 6 Months
Time frame: 6 months
Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
4 secondary outcomes
The Rate of Complete Cytogenetic Response at 6 Months
Time frame: 6 months
The Rate of Complete and Major Cytogenetic Responses at 12 Months
Time frame: 12 months
The Rate of Minor Cytogenetic Responses at 6 and 12 Months
Time frame: 6 and 12 months
The Rate of Complete Hematologic Responses at 6 and 12 Months
Time frame: 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian J. Druker, MD study chair
OHSU Knight Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytarabine and imatinib mesylate in people with Leukemia, run by OHSU Knight Cancer Institute at 2 sites 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?
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: stopped early, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 11 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Rate of Major Cytogenetic Response at 6 Months (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 7 Jan 2016.