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

ISRCTN	ISRCTN86445183
DOI	https://doi.org/10.1186/ISRCTN86445183
Protocol serial number	HO74
Sponsor	Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Funders	Dutch Cancer Society, Johnson and Johnson-Orthobiotech, Schering International, Novartis Pharma B.V., Amgen, Roche Nederland BV

Submission date: 07/06/2006
Registration date: 07/06/2006
Last edited: 07/06/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof R. Willemze
Scientific

Leiden University Medical Center (LUMC)
Department of Hematology C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5262267
Email	rwillemze@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomized, phase II study
Secondary study design	Non randomised controlled trial
Scientific title
Study acronym	HOVON 74 ALL
Study objectives	The hypothesis to be tested is that arm A and/or arm B are feasible.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Alemtuzumab, prednisone and methotrexate
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	15/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	15/05/2006
Date of final enrolment	15/04/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center (LUMC)

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Study website	Study website	11/11/2025	11/11/2025	No	Yes