Alemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse: a randomized phase II study
- Conditions
- Acute lymphoblastic leukemia (ALL)CancerLeukemia
- Registration Number
- ISRCTN86445183
- Lead Sponsor
- Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1. Age 18 - 70 years inclusive
2. First or second relapse of precursor B-cell ALL (B-ALL) or T-cell (T-ALL) (including Philadelphia chromosome or BCR-ABL tyrosine kinase positive ALL)
3. Duration of last complete remission at least 6 months
4. World Health Organization (WHO) performance status 0, 1, or 2
5. Negative pregnancy test at inclusion if applicable
6. Written informed consent
1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma
2. Acute undifferentiated leukemia (AUL)
3. Treatment with alemtuzumab at any time prior to registration
4. Intolerance of exogenous protein administration
5. Central nervous system (CNS) leukemia
6. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
7. Severe pulmonary dysfunction (Common Terminology Criteria for Adverse Events [CTCAE] grade III-IV)
8. Severe neurological or psychiatric disease
9. Significant hepatic dysfunction (serum bilirubin or transaminases >/= 3 times normal level)
10. Significant renal dysfunction (serum creatinine >/= 3 times normal level)
11. Patients with active, uncontrolled infections
12. Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration
13. Patients known to be human immunodeficiency virus (HIV)-positive
14. Patient is a lactating woman
15. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage of patients that reach a complete remission (CR) on induction cycle I in each arm<br>2. Percentage of patients with severe toxicity on induction cycle I in each arm
- Secondary Outcome Measures
Name Time Method 1. Toxicity profile related to each treatment step and intervals between treatment steps<br>2. Event-free survival (i.e. time from registration until no CR on protocol, relapse or death, whichever comes first). Event-free survival for patients without a CR is set at one day.<br>3. Disease-free survival (i.e. time from achievement of CR to date of relapse or death from any cause, whichever occurs first)<br>4. Overall survival measured from time of registration