Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
23/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hovon.nl/

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

Publication citations

Additional files

Editorial Notes