Clofarabine, Cytarabine and Mitoxantrone (CLAM) for Relapsed or Refractory AML

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML when used as first salvage for patients to relapse or fail after standard treatment with daunorubicin/cytarabine induction.

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

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Clofarabine; Cytarabine; Mitoxantrone

Criteria

Inclusion Criteria:

1. Relapsed or refractory acute myeloid leukemia (AML) after one first-line chemotherapy regimen

2. Patients aged 18 - 65 inclusively

3. European Cooperative Oncology Group (ECOG) performance status of less than 2

Exclusion Criteria:

1. Patients aged less than 18 or above 65

2. ECOG performance status of 2 or more

3. Acute promyelocytic leukaemia

4. Uncontrolled active infection

5. Uncontrolled arrhythmia

6. Altered renal dysfunction with serum creatinine > 1.5 x ULN and/or creatinine clearance < 50 mL/min

7. Significant neurologic (grade > 2) or psychiatric disorder, dementia or seizures

8. Clinical symptoms suggesting active central nervous system leukemia

9. Severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock or disseminated intravascular coagulation

10. Patients with known HIV, Hepatitis B or C infection or history of cirrhosis

11. Patients Significant hepatic dysfunction: Direct bilirubin > 1.5 x upper limit of normal (ULN) for age; ALT or AST > 3 x upper limit of normal (ULN) for age; Lipase > 2.0 x upper limit of normal (ULN) for age

12. Females of childbearing potential must have a negative pregnancy test