Chronic Myeloid Leukemia, Blast CrisisPhase 2NCT00594555
A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia
A Phase 2 study testing Imatinib Mesylate and CLAG in people with Chronic Myeloid Leukemia, Blast Crisis and Acute Myeloid Leukemia, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec) in patients with AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Blast Crisis, Acute Myeloid Leukemia
- What is being tested?
- Imatinib Mesylate and CLAG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 2008
- 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
- Men and Women of all ethnic groups whose age is ≥ 18 years old.
- Diagnosis of AML or CML blast crisis, according to WHO criteria, except acute promyelocytic leukemia AML-M3 FAB subgroup.
- Refractory or Relapsed AML.
- Refractory AML is defined as failure to achieve CR after 2 cycles of induction chemotherapy or persistent (>40%) bone marrow blasts after one cycle of chemotherapy induction.
- Relapsed AML is defined as any evidence of disease recurrence after achieving CR. Early relapse is defined as that occurring within 12 months and late relapse is defines as that occurring after 12 months.
- ECOG performance status of 0 or 1.
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- Patients must sign a written informed consent.
- Females of childbearing potential must not be pregnant or actively nursing a child. They must have a negative pregnancy test 7 days before initiation of study drug administration.
- Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Male and females of reproductive potential must agree to employ an effective barrier method of birth control throughout the duration of the trial and for 3 months following study medication discontinuation.
Who cannot join
- Abnormal Kidney Functions: creatinine ≥2.5mg/dL; if creatinine is between 2.0-2.5, patient should have GFR measured and the dose of Cytarabine may be adjusted accordingly.
- Abnormal Liver Functions: Bilirubin .2mg/dL, transaminases (AST/ALT) more that 2.5 times the institutional upper limits of normal (IULN)
- Systemic active infection, unless controlled on active therapy.
- Patients with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria ( i.e., congestive heart failure, myocardial infarction within 6 months of the study), EF 30%.
- Patient has known chronic liver disease (i.e., chronic active hepatitis and cirrhosis).
- Patient has known diagnosis of human immunodeficiency virus (HIV) infection.
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- History of other curatively untreated malignancy, except non-melanotic skin cancers.
- Patients that have received investigational agents within 1 month of study entry.
- History of allergic reaction attributed to compounds of similar chemical or biologic composition to Gleevec or any component of the CLAG regimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Acute Myeloid Leukemia
The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec) in patients with AML.
Read the detailed description
In relapsed or resistant acute myeloid leukemia (type of blood cancer where immature blood cells are increased, blocking normal blood cells production) no standard therapy exits. Response rates are similar for different chemotherapy treatments. Allogenic stem cell transplant remains the only curative option
The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec). The CLAG regimen is a combination of the chemotherapy drugs cladribine and cytarabine, as well as, neupogen which increases the white blood counts.
Imatinib Mesylate is believed to work by interfering with the abnormal protein by blocking it from telling the body to keep making more and more abnormal white blood cells. Imatinib Mesylate is approved by the FDA for the treatment of chronic myeloid leukemia (CML) and some types of acute lymphoblastic leukemia (ALL). Its use in combination with CLAG regimen is considered experimental for the treatment of Acute Myeloid Leukemia / CML blast crisis
The goal of the study is to find out what effects (good and bad) Imatinib Mesylate (Gleevec)combined with chemotherapy (CLAG regimen) on acute myeloid leukemia.
- Being tested
- Imatinib Mesylate, CLAG
- Keywords
- Blood disease, bone marrow, AML, CML,Blast Crisis
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Blast Crisis, Leukemia, Myeloid, Acute, Hematologic Diseases
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 Mesylate)
Imatinib Mesylate: 400mg po BID every day. Imatinib Mesylate will be administered Day 2 to Day 15
CLAGDrug
Also called Cladribine, Cytarabine & G-CSF (also know as CLAG)
Cladribine: 5mg/m2 administered through a 2 hour intravenous infusion daily for 5 consecutive days starting on Day 2
Cytarabine: 2gm/m2 administered through a 4 hour intravenous infusion starting 2 hours after the ignition of Cladribine for 5 days starting on Day 2
G-CSF: 300mcg sc for 6 days starting at 24 hours (Day 1) before the first dose of Cladribine; administration starting on Day 1 for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - treatment period | Experimental | Drug Name/Days Administered
Neupogen/Days 1-6
CLAG/Days 2-6
Gleevec/Days 2-15 Receives: Drug: Imatinib Mesylate; Drug: CLAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen
Measured: The amount of time it takes to enroll 20 pts. About 1 year
Secondary outcomes (1)
The sample size is calculated based on two stage Phase II clinical design. Ten patients will be accrued during stage 1 and 10 during stage 2).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Why it stopped: Principal Investigator resigned position with the University of Cincinnati, closing study at this site will reopen study in new position
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia, Blast CrisisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Rami S Komrokji, MD, Principal investigator, The University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594555
- Sponsor's protocol ID
- CST1571AU235 / Komrokji
- Other IDs
- CST1571AUS235
- Status last verified
- Oct 2008
- First submitted
- 3 Jan 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00594555
- Acronym / sponsor ID
- CST1571AU235 / Komrokji
- Keywords
- Blood disease, bone marrow, AML, CML,Blast Crisis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator resigned position with the University of Cincinnati, closing study at this site will reopen study in new position
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 15 Jan 2008 (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 purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec) in patients with AML.
Detailed description
In relapsed or resistant acute myeloid leukemia (type of blood cancer where immature blood cells are increased, blocking normal blood cells production) no standard therapy exits. Response rates are similar for different chemotherapy treatments. Allogenic stem cell transplant remains the only curative option
The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec). The CLAG regimen is a combination of the chemotherapy drugs cladribine and cytarabine, as well as, neupogen which increases the white blood counts.
Imatinib Mesylate is believed to work by interfering with the abnormal protein by blocking it from telling the body to keep making more and more abnormal white blood cells. Imatinib Mesylate is approved by the FDA for the treatment of chronic myeloid leukemia (CML) and some types of acute lymphoblastic leukemia (ALL). Its use in combination with CLAG regimen is considered experimental for the treatment of Acute Myeloid Leukemia / CML blast crisis
The goal of the study is to find out what effects (good and bad) Imatinib Mesylate (Gleevec)combined with chemotherapy (CLAG regimen) on acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - treatment period | Experimental | Drug: Imatinib Mesylate, Drug: CLAGDrug Name/Days Administered Neupogen/Days 1-6 CLAG/Days 2-6 Gleevec/Days 2-15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and Women of all ethnic groups whose age is ≥ 18 years old.
- Diagnosis of AML or CML blast crisis, according to WHO criteria, except acute promyelocytic leukemia AML-M3 FAB subgroup.
- Refractory or Relapsed AML.
- ECOG performance status of 0 or 1.
- Patients must sign a written informed consent.
Key exclusion criteria (9 listed)
- Abnormal Kidney Functions: creatinine ≥2.5mg/dL; if creatinine is between 2.0-2.5, patient should have GFR measured and the dose of Cytarabine may be adjusted accordingly.
- Abnormal Liver Functions: Bilirubin .2mg/dL, transaminases (AST/ALT) more that 2.5 times the institutional upper limits of normal (IULN)
- Systemic active infection, unless controlled on active therapy.
- Patients with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria ( i.e., congestive heart failure, myocardial infarction within 6 months of the study), EF 30%.
- Patient has known chronic liver disease (i.e., chronic active hepatitis and cirrhosis).
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 Mesylate)Imatinib Mesylate: 400mg po BID every day. Imatinib Mesylate will be administered Day 2 to Day 15 | Drug | Single Arm - treatment period |
| CLAGAlso: Cladribine, Cytarabine & G-CSF (also know as CLAG)Cladribine: 5mg/m2 administered through a 2 hour intravenous infusion daily for 5 consecutive days starting on Day 2 Cytarabine: 2gm/m2 administered through a 4 hour intravenous infusion starting 2 hours after the ignition of Cladribine for 5 days starting on Day 2 G-CSF: 300mcg sc for 6 days starting at 24 hours (Day 1) before the first dose of Cladribine; administration starting on Day 1 for 6 days | Drug | Single Arm - treatment period |
Primary outcome
Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen
Time frame: The amount of time it takes to enroll 20 pts. About 1 year
1 secondary outcome
The sample size is calculated based on two stage Phase II clinical design. Ten patients will be accrued during stage 1 and 10 during stage 2).
Time frame: 1 year
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 31 Oct 2008.
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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.
Rami S Komrokji, MD principal investigator
The University of Cincinnati
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 Imatinib Mesylate and CLAG in people with Chronic Myeloid Leukemia, Blast Crisis and Acute Myeloid Leukemia, run by University of Cincinnati 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 9 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 31 Oct 2008. 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?
Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen (time frame: The amount of time it takes to enroll 20 pts. About 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 31 Oct 2008.