Clofarabine Bone Marrow Cytoreduction
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Clofarabine
Intervention description: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line.
Intervention MeSH terms: Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a
      conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia
      blast percentage) at the time of HCT. This should lead to reduced relapse while still
      maintaining low transplant related mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent.

          -  Adequate hepatobiliary function as indicated by the following laboratory values:

               -  SGOT/SGPT <=2.5 x upper limit of normal

               -  Alkaline phosphatase <=2.5 x upper limit of normal

               -  Serum bilirubin < 1.5 mg/dl

               -  Adequate renal function as indicated by the following laboratory values:

               -  Creatinine Clearance >50 ml/min

          -  Age >/=18 years

          -  Zebroid performance status </= 2 (See Appendix A)

          -  Life expectancy is not severely limited by concomitant illness (i.e. < 3months life
             expectancy from non-leukemic conditions).

          -  No evidence of chronic active hepatitis or cirrhosis.

          -  HIV-negative

          -  Male and female patients must use an effective contraceptive method during the study
             and for a minimum of 6 months after study treatment.

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment.

        Exclusion Criteria:

          -  Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
             specified in the protocol.

          -  Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
             before study entry with the exception of hydroxyurea. The patient must have recovered
             from all acute non-hematologic toxicities from any previous .

          -  Have any other severe concurrent disease, or have a history of serious organ
             dysfunction or disease involving the heart, kidney, liver, or other organ system that
             may place the patient at undue risk to undergo treatment.

          -  Patients with a systemic fungal, bacterial, viral, or other infection not controlled
             (defined as exhibiting ongoing signs/symptoms related to the infection and without
             improvement, despite appropriate antibiotics or other treatment).

          -  Pregnant or lactating patients.

          -  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.