Condition category
Cancer
Date applied
20/08/2010
Date assigned
06/09/2010
Last edited
07/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

Contact information

Type

Scientific

Primary contact

Prof J.J. Cornelissen

ORCID ID

Contact details

Dept. of Hematology
Erasmus MC - Daniel den Hoed
P.O. box 5201
Rotterdam
3008 AE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ho70

Study information

Scientific title

Feasibility study using repeated intensive chemotherapy courses for patients with primary acute lymphoblastic leukemia in adults age 18 - 39 years inclusive: A phase II multicentre study

Acronym

HOVON 70 ALL

Study hypothesis

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

Ethics approval

The Medical Ethics Committee (MEC) of University Medical Centre Groningen approved on the 15th of August 2005 (ref: METc 2005/062)

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 (ALL)

Intervention

Patients will be treated with the following courses:
1. Pre-phase course consisting of 60 mg/m2/day for 7 days. Induction consisting of prednisone, vincristine, daunorubicin, cyclophosphamide and L-asparaginase
2. Consolidation A consisting of 6-thioguanine, cyclophosphamide and Ara-C. Consolidation B consisting of prednisone, vincristine, 6-mercaptopurine and MTX
3. Intensification IA consisting of dexamethasone, vindesine, adriamycine and L-asparaginase
4. Intensification IB consisting of 6-thioguanine, etoposide and Ara-C
5. Interphase A and B consisting of prednisone, vincristing, 6-mercaptopurine and MTX
6. Intensification IIA consisting of prednisone, vincristine, daunorubicine and L-asparaginase
7. Intensification IIB consisting of 6-thioguanine, cyclophosphamide and Ara-C
8. Maintenance consisting of 6-mercaptopurine and MTX

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Percentage of patients that reach a complete response (CR), complete all intensive phases of the protocol, and start with maintenance therapy within 11 months after start pre-phase or receive an allogeneic stem cell transplantation within 7.5 months after start pre-phase.

Secondary outcome measures

1. CR rate after remission induction, consolidation, intensification, and maintenance
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. Disease-free survival (i.e. time from achievement of CR to day of relapse or death from any cause, whichever occurs first)
5. Overall survival measured from time of registration

Overall trial start date

21/10/2005

Overall trial end date

01/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 - 39 years inclusive
2. Primary previously untreated ALL (including Philadelphia chromosome or BCR-ABL positive ALL)
3. WHO performance status 0, 1, or 2
4. Negative pregnancy test at inclusion if applicable
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Mature B-cell ALL
2. Acute undifferentiated leukemia
3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
4. Severe pulmonary dysfunction (CTCAE grade III-IV)
5. Severe neurological or psychiatric disease
6. Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times normal level)
7. Significant renal dysfunction (serum creatinine ≥ 3 times normal level)
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. Active, uncontrolled infections
10. Patient known to be HIV-positive
11. Patient is a lactating woman
12. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Recruitment start date

21/10/2005

Recruitment end date

01/09/2012

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Dept. of Hematology
Rotterdam
3008 AE
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 organisation

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

Publication citations

Additional files

Editorial Notes