CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)

Completed · Phase 2

Conditions studied: Leukemia

In brief

The purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.

Key facts

Study ID

NCT00955916

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

38

Starts

2009-08-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and Women of all ethnic groups whose age is ≥ 18 years old.
• Diagnosis of AML or CML blast crisis, according to World Health Organization (WHO) criteria, except acute promyelocytic leukemia AML-M3 French-American-British (FAB) subgroup. A documentation of relapse is required by a bone marrow/aspirate within 4 weeks of registration.
• 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 complete response (CR) (more than 5% myeloblasts). Early relapse is defined as that occurring within 12 months and late relapse is defines as that occurring after 12 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must sign a written informed consent.
• Females of childbearing potential (FOCP) 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.
• Prior allogeneic or autologous stem cell transplantation is allowed.

You may not qualify if…

• Abnormal Kidney Functions: creatinine ≥2.5 mg/dL.
• Abnormal Liver Functions: Bilirubin more 3 mg/dL, transaminases (AST/ALT) more than 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 (NYHA) Criteria ( i.e., congestive heart failure, myocardial infarction within 6 months of the study), or ejection fraction (EF)< 30%.
• Patient has known chronic liver disease (i.e., chronic active hepatitis, hepatitis B, hepatitis C, and cirrhosis).
• Patient has known diagnosis of human immunodeficiency virus (HIV) infection.
• History of other malignancy, except non-melanotic skin cancers or no disease recurrence/progression for more than 2 years.
• 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
• Prior therapy with CLAG chemotherapy regimen
• Any adverse event attributable to previous chemotherapy regimen must be resolved to grade 1 or less at time of registration.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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