Blastic Phase Chronic Myelogenous LeukemiaPhase 1/2NCT00015834
STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
A Phase 1/2 study testing imatinib mesylate and cytarabine in people with Blastic Phase Chronic Myelogenous Leukemia and Chronic Myelogenous Leukemia, BCR-ABL1 Positive, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia
- What is being tested?
- imatinib mesylate and cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Apr 2003
- Phase
- Phase 1/2
- 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
- Diagnosis of chronic myelogenous leukemia in myeloid blast crisis
- At least 30% blasts in bone marrow
- Philadelphia chromosome positive by cytogenetic analysis
- bcr/abl translocation by fluorescent in situ hybridization
- Ineligible for or refused allogeneic stem cell transplantation
- Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart
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- Performance status - ECOG 0-2
- See Disease Characteristics
- Bilirubin less than 3 times upper limit of normal (ULN)
- AST and ALT less than 3 times ULN
- Creatinine less than 2 times ULN
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients
- See Disease Characteristics
- No prior allogeneic bone marrow or peripheral blood stem cell transplantation
- At least 48 hours since prior interferon alfa
- At least 24 hours since prior hydroxyurea
- At least 6 weeks since prior busulfan
- No other prior chemotherapy for blast crisis (except hydroxyurea)
- Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed
- At least 4 weeks since prior investigational agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angeles (UCLA )
Los Angeles, California, 90095
About this study
Official title: A Phase I/II Trial of STI571 and High-Dose Cytarabine in Myeloid Blast Crisis of Chronic Myeloid Leukemia
Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of high-dose cytarabine when combined with imatinib mesylate in patients with blastic phase chronic myelogenous leukemia.
II. Determine the safety of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the frequency of hematologic and cytogenetic responses, duration of response, and survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of cytarabine.
Phase I: Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity.
Phase II: Additional patients are treated at the dose level preceding the MTD. Patients are followed monthly.
- Conditions
- Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia
- Being tested
- imatinib mesylate, cytarabine
- Medical subject headings
- Blast Crisis, 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 CGP 57148, Gleevec, Glivec
Given PO
cytarabineDrug
Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (imatinib mesylate, cytarabine) | Experimental | Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. Receives: Drug: imatinib mesylate; Drug: cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity according to NCI/NIH Common Toxicity Criteria
Described by duration, relatedness to treatment, and action taken.
Measured: Up to 2 years
Hematologic response
Measured: Up to 6 months
Bone marrow cytogenetic response
Measured: Up to 6 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 startMay 2001
- Primary completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastic Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ronald Paquette, Principal investigator, University of California at Los Angeles (UCLA )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015834
- Sponsor's protocol ID
- NCI-2012-02374
- Other IDs
- UCLA-0011009, CDR0000068441
- Status last verified
- Jan 2013
- First submitted
- 6 May 2001
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of STI571 and High-Dose Cytarabine in Myeloid Blast Crisis of Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00015834
- Acronym / sponsor ID
- NCI-2012-02374
- Conditions
- Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2001
- Primary completion
- Apr 2003 (actual)
- First posted
- 27 Jan 2003 (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.
Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of high-dose cytarabine when combined with imatinib mesylate in patients with blastic phase chronic myelogenous leukemia.
II. Determine the safety of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the frequency of hematologic and cytogenetic responses, duration of response, and survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of cytarabine.
Phase I: Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity.
Phase II: Additional patients are treated at the dose level preceding the MTD. Patients are followed monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (imatinib mesylate, cytarabine) | Experimental | Drug: imatinib mesylate, Drug: cytarabinePatients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Diagnosis of chronic myelogenous leukemia in myeloid blast crisis
- Philadelphia chromosome positive by cytogenetic analysis
- bcr/abl translocation by fluorescent in situ hybridization
- Ineligible for or refused allogeneic stem cell transplantation
- Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart
Key exclusion criteria (0 listed)
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: CGP 57148, Gleevec, GlivecGiven PO | Drug | Treatment (imatinib mesylate, cytarabine) |
| cytarabineAlso: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-UGiven IV | Drug | Treatment (imatinib mesylate, cytarabine) |
Primary outcome
Toxicity according to NCI/NIH Common Toxicity Criteria
Time frame: Up to 2 years
Described by duration, relatedness to treatment, and action taken.
Hematologic response
Time frame: Up to 6 months
Bone marrow cytogenetic response
Time frame: Up to 6 months
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 24 Jan 2013.
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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.
Ronald Paquette principal investigator
University of California at Los Angeles (UCLA )
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing imatinib mesylate and cytarabine in people with Blastic Phase Chronic Myelogenous Leukemia and Chronic Myelogenous Leukemia, BCR-ABL1 Positive, run by National Cancer Institute (NCI) 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 23 inclusion and 0 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 24 Jan 2013. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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 according to NCI/NIH Common Toxicity Criteria (time frame: Up to 2 years). The study lists 3 primary outcomes in all. 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 24 Jan 2013.