Condition category
Cancer
Date applied
13/01/2006
Date assigned
13/01/2006
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G.W. Imhoff, van

ORCID ID

Contact details

University Medical Center Groningen
Department of Hematology
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3612354
g.w.van.imhoff@int.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HO63

Study information

Scientific title

Acronym

HOVON 63 NHL

Study hypothesis

The hypothesis to be tested is that the outcome in arm B is better than in arm A.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Non Hodgkin's lymphoma (NHL)

Intervention

Patients will be randomized between:
Arm A: 6 cycles of rituximab-iCHOP every 2 weeks plus G-CSF: pegfilgrastim (Neulasta®)
Arm B: 3 cycles of rituximab-iCHOP every 2 weeks plus G-CSF: pegfilgrastim (Neulasta®), followed by rituximab-HDT Induction I, rituximab-HDT Induction II plus daily G-CSF: filgrastim (Neupogen®, SingleJect®), followed by BEAM with ASCT. Daily G-CSF: filgrastim (Neupogen® SingleJect®) will replace pegfilgrastim in the iCHOP chemotherapy cycle during which stem cells will be harvested.

Intervention type

Drug

Phase

Not Specified

Drug names

Rituximab, CHOP

Primary outcome measures

Event-free survival i.e. time from registration to induction failure (less than PR after 3 x R-iCHOP, no CR [Cru] after 6 RiCHOP [arm A] or ASCT [arm B]), death, progression or relapse whichever occurs first; the time to failure of patients with induction failure (less than PR after 3 x R-iCHOP) is set at one day.

Secondary outcome measures

1. Complete response (including CRu)
2. Progression on protocol (progression or relapse after initial PR or CR during protocol treatment)
3. Overall survival measured form the time of registration
4. Disease-free interval (duration of the first CR) measured from the time of achievement of CR (including CRu) after protocol treatment to day of relapse or death from any cause (whichever occurs first)

Overall trial start date

28/10/2005

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification
2. Ann Arbor stage II-IV
3. High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI = 2-3)
4. DLBCL must be CD20 positive
5. Age 18-65 years inclusive
6. WHO performance status </= 2
7. Negative pregnancy test (if applicable)
8. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Intolerance of exogenous protein administration
2. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF <45%
3. Significant renal dysfunction (serum creatinine >/= 150 mumol/l), unless related to NHL
4. Significant hepatic dysfunction (total bilirubin >/= 30 mumol/l or
transaminases >/= 2.5 times normal level), unless related to NHL
5. Suspected or documented Central Nervous System involvement by NHL
6. Testicular DLBCL
7. Primary mediastinal B cell lymphoma
8. Patients known to be HIV-positive
9. Patients with active, uncontrolled infections
10. Patients with uncontrolled asthma or allergy, requiring steroid treatment
11. Patient is a lactating woman
12. Unwillingness or not capable to use effective means of contraconception (all men and pre-menopausal women)
13. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (<1 week) and/or cyclophosphamide (<1 week and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms
14. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

Recruitment start date

28/10/2005

Recruitment end date

01/01/2009

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)

Sponsor details

HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391568
hdc@erasmusmc.nl

Sponsor type

Research organisation

Website

http://www.hovon.nl/

Funders

Funder type

Industry

Funder name

Amgen, Johnson & Johnson - Orthobiotech, Dutch Cancer Society, Novartis Pharma B.V., Roche Nederland BV

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