Clofarabine Bone Marrow Cytoreduction

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine

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
• 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.