Treatment of relapsed or refractory acute lymphoblastic leukemia
- Investigational treatment of very high-risk acute lymphoblastic leukemia, relapse/refractory acute myeloid leukemia
THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.
- Store vials at room temperature (250C).
- Supplied as a 20 mL vial of 1 mg/mL preservative-free solution.
- Filter through a 0.2 micron syringe filter prior to dilution.
- Further dilute with D5W or NS to a final concentration of between 0.15 - 0.4 mg/mL
- Solutions further diluted in NS or D5W are stable for 24 hours at room temperature
- Solutions compatible: NS, D5W
- Additives/above cassette Compatible: Do not mix with other drugs
- Y-site Compatible: None known.
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
|IV Intermittent Infusion||
|IV Continuous Infusion||NO|
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- Single agent (approved indication):
- 52 mg/m2 IV every 2 to 6 weeks depending on recovery from toxicity (ANC > 0.75 x 109/L).
- Investigational treatment (in combination with other chemotherapy, Children’s Oncology Group protocol AALL1131):
- 20 mg/m2 IV for 5 consecutive days (pre-medication with hydrocortisone as per AALL1131) during consolidation and delayed intensification
Dosage adjustment in renal/hepatic impairment
No information. However because clofarabine is eliminated renally, creatinine should be normal for age and if not creatinine clearance should be > 70 mL/min/1.73m2
- Common: nausea, vomiting, diarrhea, myelosuppression (neutrophils, hemoglobin, platelets), febrile neutropenia, infection, tumor lysis syndrome.
- Occasional: skin rash, pruritis, fever, rigors, tachycardia, hypotension, abdominal pain, edema, fatigue, anorexia, headache, anxiety, elevated liver function tests (ALT, AST), pericardial effusion (not of hemodynamic significance), left ventricular systolic dysfunction
- Rare: elevated bilirubin, hepatomegaly, jaundice, sepsis, capillary-leak syndrome (systemic inflammatory response syndrome SIRS) and subsequent risk of multi-organ dysfunction, arthralgia, limb pain, dizziness, dyspnea, respiratory distress, palmar-plantar erythrodysesthesia, flushing, hypertension
- If being administered as per AALL1131: administer pre-medication – hydrocortisone 100 mg/m2 IV 30-60 minutes prior to first 3 doses of clofarabine to prevent SIRS.
- Consider empiric intravenous antibiotics for febrile patients on treatment, even if not neutropenic (if being administered off-studyPatients receiving clofarabine are at increased risk of severe opportunistic infections due to the prolonged neutropenia that can result from treatment as well as the pre-existing immunocompromised state of these patients. Antimicrobial prophylaxis for fungal, viral and bacterial pathogens should be considered.
- Any patient with hypotension must have the infusion stopped immediately and the oncologist called to assess.
- Any patient exhibiting symptoms of cytokine release (tachypnea, tachycardia, hypotension, pulmonary edema) must have therapy stopped and assessment made for possible capillary-leak syndrome. Use of steroids, diuretics and albumin may be considered for these patients. Treatment can be restarted when the patient is stable at a 25% reduction.
- Clofarabine is excreted renally, renal function should be assessed regularly during treatment and if creatinine is significantly increased or CrCl/GFR < 70 mL/min/1.73m2, assessment should be made for discontinuation of drug. Other nephrotoxic agents should be avoided if possible.
- The liver is a target organ for clofarabine toxicity and hepatic function must be assessed regularly during treatment. Elevated liver enzymes (ALT, AST) are usually rapidly reversible however elevated bilirubin has taken longer to resolve (median of 6 days to achieve < grade 2 toxicity).
- Continuous IV fluids should be administered throughout clofarabine treatment to reduce effects of tumor lysis and other adverse events. If hyperuricemia is present or expected, appropriate treatment e.g. allopurinol/hydration (see Tumor Lysis orders) should be undertaken.