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
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