HOVON HO74

Archived

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

Scheduled
Actual
2006
11 May
Activated
2007
19 Oct
CloseoutInProgressLastPtOutActualStart
2017
19 Oct
Archived

Flow

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

Site
8 results
Order by
Accrual rate
Activation date
NL-Rotterdam-ERASMUSMC
1
NL-Leiden-LUMC
1
NL-Amsterdam-AMC
NL-Rotterdam-EMCDANIEL
NL-Maastricht-MUMC
NL-Enschede-MST
NL-Nieuwegein-ANTONIUS
NL-Amsterdam-VUMC
= Active hospitals
= Inactive hospitals

Participating Parties

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