A randomised phase III study on the effect of the chimeric anti-CD20 monoclonal antibody (MabThera®) during sequential chemotherapy followed by autologous stem cell transplantation in patients with relapsed or progressive B-cell non-Hodgkins lymphoma

ISRCTN	ISRCTN95614846
DOI	https://doi.org/10.1186/ISRCTN95614846
ClinicalTrials.gov number	NCT00012051
Secondary identifying numbers	NTR188; Ho44

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 28/01/2019

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

Study website

Contact information

Prof E. Vellenga
Scientific

University Medical Center Groningen
Department of Hematology
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 2354
Email	e.vellenga@int.umcg.nl

Study information

Study design	Multicentre randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL: a prospective randomized HOVON trial.
Study acronym	HOVON 44 NHL
Study objectives	Evaluation of the effect of MabThera® with respect to response to reinduction treatment before autologous stem cell transplantation and overall survival and event free survival after autologous stem cell transplantation.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Non-Hodgkin's lymphoma (NHL)
Intervention	Patients will be randomised to: Arm A: Cycle I: DHAP Cycle II: VIM, in case of partial remission (PR) or complete remission (CR) Cycle III: DHAP or VIM, BEAM + autologous SCT Arm B: Cycle I: DHAP + rituximab Cycle II: VIM + rituximab, in case of PR or CR Cycle III: DHAP or VIM + rituximab, BEAM + autologous SCT
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	MabThera®, rituximab; dexamethasone, cytarabine, cisplatin (DHAP); carmustine, etoposide, cytarabine, melphalan (BEAM); etoposide, ifosfamide, mitoxantrone, prednisone (VIM)
Primary outcome measure	Overall survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive.
Secondary outcome measures	1. Response to DHAP-VIM with or without rituximab (MabThera®) 2. Event-free survival (i.e. time from registration to the date of stable disease after both the first and second reinduction cycle, documented progression, relapse or death, whichever comes first)
Overall study start date	20/11/2000
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Malignant lymphoma based upon a representative histology specimen according to the REAL classification at relapse or progression: 1.1. Follicular center lymphoma, follicular (grade III) 1.2. Diffuse large B-cell lymphoma 1.3. Primary mediastinal B-cell lymphoma 2. CD20 positive 3. First progression or relapse during/after adriamycin containing regimen. 'Progressive' includes patients who have progressive disease (PD, without prior response) and patients who have progression after first PR 4. Aged 18 - 65 years inclusive 5. World Health Organization (WHO) performance status 0 - 1 6. Witnessed written informed consent according to the center requirements
Key exclusion criteria	1. Patients with history of intolerance of exogenous protein administration 2. Patients with severe cardiac dysfunction (New York Heart Association [NYHA] classification II - IV) 3. Patients with severe pulmonary dysfunction (vital capacity or diffusion capacity less than 70% of predicted value) unless clearly related to non-Hodgkins Lymphoma (NHL) involvement 4. Patients with hepatic dysfunction, bilirubin or transaminase greater than or equal to 25 x upper normal limit 5. Patients with renal dysfunction (serum creatinine greater than or equal to 180 mmol/l or clearance less than or equal to 40 ml/min) 6. Prior treatment with immunotherapy or radiation therapy within the last month before entering the study 7. Patients with active uncontrolled infections 8. Patients known to be human immunodeficiency virus (HIV)-positive 9. Patients with NHL localisation in the central nervous system 10. Patients with (EBV) post-transplant lymphoproliferative disorder
Date of first enrolment	20/11/2000
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen

Groningen
9700 RB
Netherlands

Sponsor information

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

Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 2693
Email	hdc@hovon.nl
Website	http://www.hovon.nl/
"ROR"	https://ror.org/056kpdx27

Funders

Funder type

Research organisation

Koningin Wilhelmina Fonds (KWF) (Netherlands)

No information available

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