Contact information
Type
Scientific
Primary contact
Dr A.W. Dekker
ORCID ID
Contact details
University Medical Center Utrecht
Department of Hematology
(G03.647)
P.O. Box 85500
Utrecht
3508 GA
Netherlands
030 2507655
a.w.dekker@azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO37
Study information
Scientific title
Acronym
HOVON 37 ALL
Study hypothesis
Patients who are in first Complete Response (CR) after autologous transplantation, may be randomised between no further treatment (arm A) and maintenance chemotherapy (arm B). The hypothesis to be tested is that maintenance therapy will prolong disease free survival, calculated from the date of randomisation.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute Lymphoblastic Leukaemia (ALL)
Intervention
All patients will receive early intensification:
Cycle 1: prednisone, vincristine, daunorubicin, aspariganse, MTX i.t.
Cycle 2: Cytarabine, Mitoxantrone, MTX i.t.
Cycle 3: Methotrexate, asparaginase, 6-MP, MTX i.t.
After intensification patients will receive either an allogeneic sibling stem cell transplantation, a matched unrelated donor stem cell transplantation or an autologous stem cell transplantation.
Patients who received an autologous stem cell transplantation will be randomised between:
Arm A: no further treatment.
Arm B: maintenance treatment with 6-MP and MTX.
Intervention type
Drug
Phase
Phase II
Drug names
Prednisone, vincristine, daunorubicin, aspariganse, methotrexate (MTX), cytarabine, mitoxantrone, mercaptopurine (6-MP)
Primary outcome measures
Response after each course of chemotherapy and date of CR.
Secondary outcome measures
1. Disease-free survival (i.e. time from achievement of first CR to the date of relapse or death from any cause, whichever occurs first)
2. Event-free survival (i.e. time from start of therapy to the date of no complete response, death or relapse whichever occurs first): this takes into consideration induction failures and toxic deaths. The time to failure of patients with induction failure is set at one day
3. Overall survival will be measured from time of registration until death or last contact
4. Toxicities and treatment related mortality
Overall trial start date
01/04/1999
Overall trial end date
01/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age between 16 and 59 (inclusive) years
2. Previously untreated with chemotherapy
3. Acute Lymphoblastic Leukaemia (ALL) according to the French-American-British (FAB) criteria and immunological marker analysis (B-precursor ALL, T-cell Acute Lymphoblastic Leukaemia [T-ALL] and Acute Undifferentiated Leukaemia [AUL])
4. World Health Organisation (WHO) performance status grade zero, one, two or three
5. Patient gives informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
1. B-ALL (= mature B-ALL)
2. Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease
3. Second malignant disease, except cervix carcinoma stage I and non-melanoma skin cancer
4. Persisting renal insufficiency, creatinine more than 200 mmol/l
5. Active uncontrolled infections
6. Human Immunodeficiency Virus (HIV) positivity on serological tests
Recruitment start date
01/04/1999
Recruitment end date
01/11/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht,
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Sponsor details
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2693
hdc@hovon.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Koningin Wilhelmina Fonds (KWF) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) (The Netherlands)
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