Philadelphia Chromosome Positive Acute Lymphocytic LeukemiaPhase 2NCT00154349
Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia
A Phase 2 study testing Imatinib Mesylate in people with Philadelphia Chromosome Positive Acute Lymphocytic Leukemia, run by Novartis Pharmaceuticals.
Trial summary
The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
- What is being tested?
- Imatinib Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Feb 2007
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically confirmed diagnosis of ALL.
- Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.
- Patients in relapse
- Patients refractory to initial remission induction therapy
- Patients ineligible for initial remission induction therapy
- Patients with an ECOG Performance Status Score from 0 to 2
Show all 9Show fewer
- Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN)
- AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN
- Serum bilirubin level not more than 3 × ULN
Who cannot join
- Patients with findings indicative of leukemic involvement of the central nervous system
- Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder)
- Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
- Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).
- Being tested
- Imatinib Mesylate
- Keywords
- Ph+ALL, imatinib mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
Also called STI571,, Glivec,, Gleevec
| 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.
3 month hematological response rate
Secondary outcomes (3)
Duration of hematological response
Survival
Cytogenetic response in every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome Positive Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154349
- Sponsor's protocol ID
- CSTI571I1203
- Status last verified
- Feb 2017
- First submitted
- 9 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00154349
- Acronym / sponsor ID
- CSTI571I1203
- Keywords
- Ph+ALL, imatinib mesylate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Sep 2005 (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 objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).
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
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically confirmed diagnosis of ALL.
- Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.
- Patients in relapse
- Patients refractory to initial remission induction therapy
- Patients ineligible for initial remission induction therapy
Key exclusion criteria (5 listed)
- Patients with findings indicative of leukemic involvement of the central nervous system
- Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder)
- Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
- Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.
- Other protocol-defined inclusion/exclusion criteria may apply.
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: STI571,, Glivec,, Gleevec | Drug | imatinib mesylate |
Primary outcome
3 month hematological response rate
3 secondary outcomes
Duration of hematological response
Survival
Cytogenetic response in every 3 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 23 Feb 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib Mesylate in people with Philadelphia Chromosome Positive Acute Lymphocytic Leukemia, run by Novartis Pharmaceuticals.
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 9 inclusion and 5 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
3 month hematological response rate. 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 23 Feb 2017.