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

Phase 2
18 Years
Not Enrolling
Chronic Myeloid Leukemia, Blast Crisis, Acute Myeloid Leukemia

Thank you

Trial Information

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

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.

Inclusion 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 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen

Outcome Time Frame:

The amount of time it takes to enroll 20 pts. About 1 year

Safety Issue:


Principal Investigator

Rami S Komrokji, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Cincinnati


United States: Institutional Review Board

Study ID:

CST1571AU235 / Komrokji



Start Date:

November 2007

Completion Date:

November 2008

Related Keywords:

  • Chronic Myeloid Leukemia, Blast Crisis
  • Acute Myeloid Leukemia
  • Blood disease, bone marrow
  • AML
  • CML,Blast Crisis
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



University of Cincinnati Cincinnati, Ohio  45267-0502