Know Cancer

forgot password

A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Relapsed or Refractory Acute Myeloid Leukemia

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Relapsed or Refractory Acute Myeloid Leukemia

In relapsed or resistant acute myeloid leukemia (a type of blood cancer where immature blood
cells are increased, blocking normal blood cell production), different types of chemotherapy
are used for treatment. Patients responded to all the chemotherapies in similar ways, but
most of the responses did not last long if further stem cell transplantation was not done.
Gleevec is believed to work by interfering with the abnormal protein by blocking it from
telling the body to keep making more white blood cells that are abnormal.

The CLAG regimen is the standard chemotherapy used for relapsed AML (Acute Myeloid
Leukemia). This study will add Gleevec® to the regimen for a period of 14 days. Gleevec®
is approved by the Food and Drug Administration (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) Gleevec® (Imatinib
mesylate) combined with chemotherapy has on you and your acute myeloid leukemia.

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

- 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 ≥2.5mg/dL.

- Abnormal Liver Functions: Bilirubin more 3 mg/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 (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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants' Overall Response (OR)

Outcome Description:

The primary endpoint is to determine the overall response rate as well as toxicity of CLAG-Gleevec combination regimen (Cladribine, cytarabine, G-CSF, and Imatinib Mesylate) in treatment of refractory or relapsed acute myeloid leukemia.

Outcome Time Frame:

12 weeks per patient

Safety Issue:


Principal Investigator

Rami Komrokji, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

September 2014

Related Keywords:

  • Leukemia
  • relapsed
  • refractory
  • acute
  • myeloid
  • AML
  • CML
  • blast crisis
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612