Condition category
Cancer
Date applied
20/08/2010
Date assigned
06/09/2010
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

http://www.hovon.nl

Contact information

Type

Scientific

Primary contact

Dr S.M.G.J. Daenen

ORCID ID

Contact details

Dept. of Hematology
UMCG
P.O. box 30001
Groningen
9700 RB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ho71

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

Acronym

HOVON 71 ALL

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

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Acute Lymphoblastic Leukemia

Intervention

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

Other

Phase

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

21/10/2005

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

55

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

21/10/2005

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Dept. of Hematology
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

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
Rotterdam
3008 AE
Netherlands
+31 (0)10 7041560
hdc@erasmusmc.nl

Sponsor type

Research council

Website

http://www.hovon.nl

Funders

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

Location

Funder name

Dutch Cancer Fund (KWF) (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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22358264

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