A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia
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| ClinicalTrials.gov Identifier: NCT00594555 |
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Recruitment Status :
Withdrawn
(Principal Investigator resigned position with the University of Cincinnati, closing study at this site will reopen study in new position)
First Posted : January 15, 2008
Last Update Posted : October 31, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Myeloid Leukemia, Blast Crisis Acute Myeloid Leukemia | Drug: Imatinib Mesylate Drug: CLAG | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Acute Myeloid Leukemia |
| Study Start Date : | November 2007 |
| Estimated Primary Completion Date : | November 2008 |
| Estimated Study Completion Date : | November 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Single Arm - treatment period
Drug Name/Days Administered Neupogen/Days 1-6 CLAG/Days 2-6 Gleevec/Days 2-15 |
Drug: Imatinib Mesylate
Imatinib Mesylate: 400mg po BID every day. Imatinib Mesylate will be administered Day 2 to Day 15
Other Name: Gleevec (Imatinib Mesylate) Drug: 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 Other Name: Cladribine, Cytarabine & G-CSF (also know as CLAG) |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- 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.
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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.
- 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.
Exclusion Criteria
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594555
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| Principal Investigator: | Rami S Komrokji, MD | The University of Cincinnati |
| Responsible Party: | Rami Komrokji, MD, The University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00594555 |
| Other Study ID Numbers: |
CST1571AU235 / Komrokji CST1571AUS235 |
| First Posted: | January 15, 2008 Key Record Dates |
| Last Update Posted: | October 31, 2008 |
| Last Verified: | October 2008 |
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Blood disease, bone marrow AML CML,Blast Crisis |
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelogenous, Chronic, BCR-ABL Positive Blast Crisis Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Cell Transformation, Neoplastic Carcinogenesis Neoplastic Processes Pathologic Processes |
Cytarabine Imatinib Mesylate Cladribine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors |