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A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594555
Recruitment Status : Withdrawn (Principal Investigator resigned position with the University of Cincinnati, closing study at this site will reopen study in new position)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
Information provided by:
University of Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia, Blast Crisis Acute Myeloid Leukemia Drug: Imatinib Mesylate Drug: CLAG Phase 2

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.

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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
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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). [ Time Frame: 1 year ]

Information from the National Library of Medicine

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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.
  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00594555

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
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Principal Investigator: Rami S Komrokji, MD The University of Cincinnati
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Responsible Party: Rami Komrokji, MD, The University of Cincinnati Identifier: NCT00594555    
Other Study ID Numbers: CST1571AU235 / Komrokji
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008
Keywords provided by University of Cincinnati:
Blood disease, bone marrow
CML,Blast Crisis
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Antimetabolites, Antineoplastic
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