Condition category
Cancer
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

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

Publication citations

Additional files

Editorial Notes