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
Protocol serial number	Ho70
Sponsor	Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Funders	Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands), Dutch Cancer Fund (KWF) (Netherlands)

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

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

Primary study design	Interventional
Study design	Prospective phase II multicentre non-randomised trial
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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
Study acronym	HOVON 70 ALL
Study objectives	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(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) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	21/10/2005
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

Belgium
Netherlands

Study participating centre

Dept. of Hematology

Rotterdam
3008 AE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes