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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Novartis
• Treatments: Cladribine; Cytarabine; Imatinib Mesylate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.