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

NCT00594555 | Withdrawn Phase 2

• 2 other identifiers: CST1571AU235 / KomrokjiCST1571AUS235
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia, Blast Crisis; Acute Myeloid Leukemia

Keywords

Blood disease, bone marrow; AML; CML,Blast Crisis

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (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).

  1 year

Study Arms (1)

Single Arm - treatment period

EXPERIMENTAL

Drug Name/Days Administered Neupogen/Days 1-6 CLAG/Days 2-6 Gleevec/Days 2-15

Drug: Imatinib Mesylate; Drug: CLAG

Interventions

Imatinib Mesylate DRUG

Imatinib Mesylate: 400mg po BID every day. Imatinib Mesylate will be administered Day 2 to Day 15

Also known as: Gleevec (Imatinib Mesylate)

Single Arm - treatment period

CLAG DRUG

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

Also known as: Cladribine, Cytarabine & G-CSF (also know as CLAG)

Single Arm - treatment period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Novartis: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis; Leukemia, Myeloid, Acute; Hematologic Diseases

Interventions

Imatinib Mesylate; Cladribine; Cytarabine; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cytidine; Pyrimidine Nucleosides; Arabinonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Rami S Komrokji, MD

  The University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 31, 2008

Record last verified: 2008-10

Locations

US (1)