Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information



Primary contact

Dr S.M.G.J. Daenen


Contact details

Dept. of Hematology
P.O. box 30001
9700 RB

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Treatment of acute lymphoblastic leukemia (ALL) in adults age 40 - 70 years inclusive with chemotherapy including a "pre-induction course" for rapid tumor load reduction and prolonged maintenance chemotherapy: A phase II multicentre study



Study hypothesis

The hypothesis to be tested is that treatment with 1 prephase course, 2 induction courses, 1 consolidation course, Allogenic Stem Cell Transplantation (allo-SCT) or maintenance treatment is feasible, and efficacy meets the expectations as described in the protocol.

Please note that as of 11/10/2012, the anticipated end date for this trial was updated from 01/01/2013 to 30/06/2011.

Ethics approval

The Medical Ethics Committee (MEC) of University Medical Centre Groningen approved on the 22nd of August 2005 (ref: METc 2005/063)

Study design

Prospective phase II multicentre non-randomised trial

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet


Acute Lymphoblastic Leukemia


Patients will be treated with the following courses:
1. Pre-induction course consisting of Ara-C 200 mg/m2/day, 2 days, etoposide 120 mg/m2/day, 2 days, MTX 500 mg/m2/day, 2 days and leucovorin.
2. 2 ODA induction courses consisting of dexamethasone 8-12 mg/day, 21 days, vincristine 1 mg/day, 3 days and adriamycine 30-40 mg/m2/day, 3 days.
3. Consolidation course consisting of Ara-C 1000 mg/m2/12 hr, 2 days and L-asparaginase 6000 IU/m2/day, 10 days.
4. Patients will then either go for allo-SCT or maintenance treatment.
4.1. Maintenance treatment consisting of 30 courses every 4 weeks, which are 23 regular (R) courses (prednisone 1 mg/kg/day, 7 days, vincristine 1-2 mg/day, 1 day, MTX 15 mg/m2/day, 3 days, 6-Mercaptopurine 75 mg/m2/day, 21 days) interspersed with 4 courses of intensification A (prednisone and vincristine same dose and schedule as regular, Ara-C 200 mg/m2/day, 3 days and etoposide 120 mg/m2/day, 3 days) and 3 courses of intensification B (prednisone and vincristine same dose and schedule as regular, mitoxantrone 8 mg/m2/day, 1 day, cyclophosphamide 750 mg/m2/day, 1 day and a medication free period of 20 days).

Intervention type



Phase II

Drug names

Primary outcome measures

Disease-free survival (i.e. time from achievement of complete response [CR] to day of relapse or death from any cause, whichever comes first)

Secondary outcome measures

1. CR rate after remission induction and consolidation
2. Toxicity profile related to each treatment step and intervals between treatment steps
3. 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
4. Overall survival measured from time of registration
5. Outcome of patients with a reduced intensity conditioning allogeneic stem cell transplantation

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age 40 - 70 years inclusive
2. Primary previously untreated ALL*
3. WHO performance status 0, 1, or 2
4. Negative pregnancy test at inclusion if applicable
5. Written informed consent

*Patients with mediastinal mass defining the so-called T-lymphoblastic leukemia/lymphoma are eligible for this trial. ALL patients with Philadelphia chromosome - t(9;22) and variants - are also eligible for this trial. However, when an alternative trial for Philadelphia chromosome positive patients becomes available, patients should be included in that trial by preference.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma
2. Acute undifferentiated leukemia (AUL)
3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
4. Severe pulmonary dysfunction (Common Terminology Criteria for Adverse Events [CTCAE] grade III-IV)
5. Severe neurological or psychiatric disease
6. Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times normal level) except when caused by leukemic infiltration
7. Significant renal dysfunction (serum creatinine ≥ 3 times normal level after rehydration and correction of hyperuricemia)
8. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
9. History of anthracycline use exceeding a cumulative dose of 300 mg/m2 doxorubicin (or its biological equivalent)
10. Active, uncontrolled infections
11. Patient known to be HIV-positive

Recruitment start date


Recruitment end date



Countries of recruitment

Belgium, Netherlands

Trial participating centre

Dept. of Hematology
9700 RB

Sponsor information


Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Sponsor details

P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O. box 5201
3008 AE
+31 (0)10 7041560

Sponsor type

Research council



Funder type

Research organisation

Funder name

Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Dutch Cancer Fund (KWF) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

1. 2012 results in

Publication citations

  1. Results

    Daenen S, van der Holt B, Dekker AW, Willemze R, Rijneveld AW, Biemond BJ, Muus P, van de Loosdrecht AA, Schouten HC, van Marwijk Kooy M, Breems DA, Demuynck H, Maertens J, Wijermans PW, Wittebol S, de Klerk EW, Cornelissen JJ, , , Intensive chemotherapy to improve outcome in patients with acute lymphoblastic leukemia over the age of 40: a phase II study for efficacy and feasibility by HOVON., Leukemia, 2012, 26, 7, 1726-1729, doi: 10.1038/leu.2012.53.

Additional files

Editorial Notes