Main info

Identifier:

HOVON 74 ALL

Sponsor:

HOVON

Included patients:

2

Active sites:

8

(of 8)

Title:

Alemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse
A randomized phase II study.

Timeline

Flow

Details

Phase:

Prospective randomized Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Age 18 - 70 years inclusive
• First or second relapse of precursor B-ALL or T-ALL (including Philadelphia chromosome or BCR-ABL positive ALL)
• Duration of last complete remission at least 6 months
• WHO performance status 0, 1, or 2
• Negative pregnancy test at inclusion if applicable
• Written informed consent

Exclusion Criteria:

• Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma
• Acute undifferentiated leukemia (AUL)
• Treatment with alemtuzumab at any time prior to registration
• Intolerance of exogenous protein administration
• Central nervous system (CNS) leukemia (appendix A)
• Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
• Severe pulmonary dysfunction (CTCAE grade III-IV)
• Severe neurological or psychiatric disease
• Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times normal level)
• Significant renal dysfunction (serum creatinin >= 3 times normal level)
• Patients with active, uncontrolled infections
• Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration
• Patients known to be HIV-positive
• Patient is a lactating woman
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Participating Sites

= Active hospitals

= Inactive hospitals