Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndromes; Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Intervention: Clofarabine and Cytarabine
Intervention description: Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in selected Elderly Patients at high risk of anthracycline toxicity
Intervention MeSH terms: Cytarabine; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: AML; MDS; CML; Relapsed; Refractory; Chemo treatment; Clofarabine; Cytarabine; standard or poor cytogenetic risk AML; untreated high-risk (>10% blasts) MDS; CML in accelerated phase or blast crisis; Elderly AML patients with risk of anthracycline toxicity

Summary:

      The purpose of this trial is to to determine the safety and effectiveness of therapeutic
      combination - Clofarabine and Cytarabine for the treatment of AML and MDS.
    

Eligibility criteria:

        Adult patients who are at least 18 years old with histologically confirmed disease as
        follows:

          -  Standard or poor cytogenetic risk acute myelogenous leukemia (AML) according to the
             Southwestern Oncology Group (SWOG) criteria in first relapse or primary refractory
             status

          -  Untreated high-risk myelodysplastic syndrome (MDS) defined as >10% blasts

          -  Chronic myelogenous leukemia (CML) in accelerated phase or blast crisis failing
             imatinib therapy.

          -  Selected elderly patients with untreated AML who are at high risk of anthracycline
             toxicity.

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or

          -  Laboratory values obtained less than or equal to 7 days prior to receiving study
             treatment:

               -  Total bilirubin < 2.0 mg/dL unless elevated due to hemolysis

               -  Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 5 ×
                  upper limit of normal (ULN)

               -  Serum creatinine < 2.0 mg/dL

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent.

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment.

          -  Male and female patients must use an effective contraceptive method during the study
             and for a minimum of 6 months after study treatment.

        Exclusion Criteria:

          -  Patients with FAB M3 unless relapsed after treatment with ATRA and arsenic trioxide.

          -  Patients eligible to receive curative allogeneic transplant as determined by
             performance status, organ function, availability of a matched donor, etc.

          -  Current concomitant chemotherapy, radiation therapy, or immunotherapy.

          -  Use of investigational agents within 30 days or any anticancer therapy within 3 weeks
             before study entry. The patient must have recovered from all acute toxicities from any
             previous therapy.

          -  Active heart disease including myocardial infarction within the preceding 3 months.

          -  History of severe coronary artery disease, arrhythmias other than atrial flutter or
             fibrillation requiring medication, or uncontrolled congestive heart failure

          -  Dyspnea at rest or with minimal exertion.

          -  Patients with an active, uncontrolled systemic infection considered to be
             opportunistic, life-threatening, or clinically significant at the time of treatment or
             with a known or suspected fungal infection (ie, patients on parenteral antifungal
             therapy).

          -  Pregnant or lactating patients.

          -  Prior enrollment in this trial.

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results.