Contact information
Type
Scientific
Primary contact
Prof R. Willemze
ORCID ID
Contact details
Leiden University Medical Center (LUMC)
Department of Hematology C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262267
rwillemze@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO74
Study information
Scientific title
Acronym
HOVON 74 ALL
Study hypothesis
The hypothesis to be tested is that arm A and/or arm B are feasible.
Ethics approval
Not provided at time of registration
Study design
Randomized, phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute lymphoblastic leukemia (ALL)
Intervention
Relapsed ALL patients under the age of 71 years will be registered and randomized to receive:
Arm A: prednisone and methotrexate in the pre-phase and thereafter two remission induction courses of alemtuzumab 30 mg
Arm B: prednisone and methotrexate in the pre-phase and thereafter two remission induction courses of alemtuzumab 60 mg
Intervention type
Drug
Phase
Phase II
Drug names
Alemtuzumab, prednisone and methotrexate
Primary outcome measures
1. Percentage of patients that reach a complete remission (CR) on induction cycle I in each arm
2. Percentage of patients with severe toxicity on induction cycle I in each arm
Secondary outcome measures
1. Toxicity profile related to each treatment step and intervals between treatment steps
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.
3. Disease-free survival (i.e. time from achievement of CR to date of relapse or death from any cause, whichever occurs first)
4. Overall survival measured from time of registration
Overall trial start date
15/05/2006
Overall trial end date
15/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
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
Recruitment start date
15/05/2006
Recruitment end date
15/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Sponsor details
HOVON Data Center
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391568
hdc@erasmusmc.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Dutch Cancer Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Johnson and Johnson-Orthobiotech
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Schering International
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novartis Pharma B.V.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Amgen
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
Roche Nederland BV
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary