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

ISRCTN ISRCTN78775328
DOI https://doi.org/10.1186/ISRCTN78775328
Secondary identifying numbers Ho70
Submission date
20/08/2010
Registration date
06/09/2010
Last edited
07/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof J.J. Cornelissen
Scientific

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

Study information

Study designProspective phase II multicentre non-randomised trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleFeasibility 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
Study acronymHOVON 70 ALL
Study objectivesThe 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(s)The Medical Ethics Committee (MEC) of University Medical Centre Groningen approved on the 15th of August 2005 (ref: METc 2005/062)
Health condition(s) or problem(s) studiedAcute Lymphoblastic Leukemia (ALL)
InterventionPatients 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 typeOther
Primary outcome measurePercentage 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 measures1. 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 study start date21/10/2005
Completion date01/09/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment21/10/2005
Date of final enrolment01/09/2012

Locations

Countries of recruitment

  • Belgium
  • Netherlands

Study participating centre

Dept. of Hematology
Rotterdam
3008 AE
Netherlands

Sponsor information

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

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
http://www.hovon.nl
ROR logo https://ror.org/056kpdx27

Funders

Funder type

Research organisation

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

No information available

Dutch Cancer Fund (KWF) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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