Early intensification by (un)-related allogeneic or autologous stem cell transplantation in adult Acute Lymphoblastic Leukaemia: a phase II study

ISRCTN	ISRCTN77441569
DOI	https://doi.org/10.1186/ISRCTN77441569
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	HO37, NL191 (NTR228)
Sponsor	Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Funders	Koningin Wilhelmina Fonds (KWF) (The Netherlands), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 26/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A.W. Dekker
Scientific

University Medical Center Utrecht
Department of Hematology, (G03.647)
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	030 2507655
Email	a.w.dekker@azu.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Early intensification by (un)-related allogeneic or autologous stem cell transplantation in adult Acute Lymphoblastic Leukaemia: a phase II study
Study acronym	HOVON 37 ALL
Study objectives	Patients who are in first Complete Response (CR) after autologous transplantation, may be randomised between no further treatment (arm A) and maintenance chemotherapy (arm B). The hypothesis to be tested is that maintenance therapy will prolong disease free survival, calculated from the date of randomisation.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Acute Lymphoblastic Leukaemia (ALL)
Intervention	All patients will receive early intensification: Cycle 1: prednisone, vincristine, daunorubicin, aspariganse, MTX i.t. Cycle 2: Cytarabine, Mitoxantrone, MTX i.t. Cycle 3: Methotrexate, asparaginase, 6-MP, MTX i.t. After intensification patients will receive either an allogeneic sibling stem cell transplantation, a matched unrelated donor stem cell transplantation or an autologous stem cell transplantation. Patients who received an autologous stem cell transplantation will be randomised between: Arm A: no further treatment. Arm B: maintenance treatment with 6-MP and MTX.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Prednisone, vincristine, daunorubicin, aspariganse, methotrexate (MTX), cytarabine, mitoxantrone, mercaptopurine (6-MP)
Primary outcome measure(s)	Response after each course of chemotherapy and date of CR.
Key secondary outcome measure(s)	1. Disease-free survival (i.e. time from achievement of first CR to the date of relapse or death from any cause, whichever occurs first) 2. Event-free survival (i.e. time from start of therapy to the date of no complete response, death or relapse whichever occurs first): this takes into consideration induction failures and toxic deaths. The time to failure of patients with induction failure is set at one day 3. Overall survival will be measured from time of registration until death or last contact 4. Toxicities and treatment related mortality
Completion date	01/11/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	1. Age between 16 and 59 (inclusive) years 2. Previously untreated with chemotherapy 3. Acute Lymphoblastic Leukaemia (ALL) according to the French-American-British (FAB) criteria and immunological marker analysis (B-precursor ALL, T-cell Acute Lymphoblastic Leukaemia [T-ALL] and Acute Undifferentiated Leukaemia [AUL]) 4. World Health Organisation (WHO) performance status grade zero, one, two or three 5. Patient gives informed consent
Key exclusion criteria	1. B-ALL (= mature B-ALL) 2. Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease 3. Second malignant disease, except cervix carcinoma stage I and non-melanoma skin cancer 4. Persisting renal insufficiency, creatinine more than 200 mmol/l 5. Active uncontrolled infections 6. Human Immunodeficiency Virus (HIV) positivity on serological tests
Date of first enrolment	01/04/1999
Date of final enrolment	01/11/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht,

Utrecht
3508 GA
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?
Results article		07/06/2011	26/08/2021	Yes	No
Results article		23/02/2021	26/08/2021	Yes	No

Editorial Notes

26/08/2021: Publication references added.