Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

Contact information

Type

Scientific

Primary contact

Prof E. Vellenga

ORCID ID

Contact details

University Medical Center Groningen
Department of Hematology
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 2354
e.vellenga@int.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00012051

Protocol/serial number

NTR188; Ho44

Study information

Scientific title

Acronym

HOVON 44 NHL

Study hypothesis

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

Received from the local medical ethics committee

Study design

Multicentre randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

MabThera®, rituximab; dexamethasone, cytarabine, cisplatin (DHAP); carmustine, etoposide, cytarabine, melphalan (BEAM); etoposide, ifosfamide, mitoxantrone, prednisone (VIM)

Primary outcome measures

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 trial start date

20/11/2000

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

20/11/2000

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

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

Sponsor details

Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2693
hdc@hovon.nl

Sponsor type

Research organisation

Website

http://www.hovon.nl/

Funders

Funder type

Research organisation

Funder name

Koningin Wilhelmina Fonds (KWF) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Publication citations

Additional files

Editorial Notes