Standard chemotherapy combination (Cyclophosphamide, Hydroxydaunorubicin, Vincristine, Prednisolone [CHOP]) with 1, 3 or 6 cycles of the monoclonal anti-CD20-antibody. Rituximab in first line therapy of follicular non-Hodgkins lymphoma.

ISRCTN	ISRCTN47525145
DOI	https://doi.org/10.1186/ISRCTN47525145
Protocol serial number	N/A
Sponsor	University of Heidelberg (Germany)
Funder	Sponsored and funded by Roche and University of Heidelberg

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Anthony Ho
Scientific

Im Neuenheimer Feld 410
Heidelberg
69120
Germany

Phone	+49 (0)6221 568001
Email	sekretariat_ho@med.uni-heidelberg.de

Primary study design	Interventional
Study design	Randomised Controlled Trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	HD2000
Study objectives	Six infusions of Rituximab, added to 6 cycles of standard chemotherapy (CHOP), are more effective than 1 or 3 infusions of Rituximab in the production of a molecular remission, as determined by t(14;18) real time Polymerase Chain Reaction (PCR) in peripheral blood and bone marrow.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Follicular Lymphoma World Health Organisation (WHO) Grade I and II, Stage 3-4
Intervention	6 x CHOP + 1 x Rituximab versus 6 x CHOP + 3 x Rituximab versus 6 x CHOP + 6 x Rituximab
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	CHOP and Rituximab
Primary outcome measure(s)	Molecular remission rate after the end of six cycles of CHOP with various cycles of Rituximab antibodies, determined by t(14;18) real time PCR in peripheral blood and bone marrow.
Key secondary outcome measure(s)	1. Clinical remission rate 2. Duration of molecular and clinical response 3. Toxicity
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Patients with histologically proven CD20+ follicular lymphoma (follicular lymphoma grade I, II), stage III and IV 2. Age >18 years, no upper limit 3. No pre-treatment except irradiation and/or corticosteroids 4. Requirement of therapy: one or more of the following: B-symptoms, hematopoietic insufficiency (leukopenia <1.5/nl, anemia hb <10 g/dl, platelets <100/nl) 5. Objective tumor progression (>50% increase in sum of tumor diameters in six months); 'bulky disease' (mediastinal/abdominal tumor >7.5 cm and/or other lymphnodes >5 cm)
Key exclusion criteria	1. Age <18 years 2. Stage I or II 3. CD20 negativity 4. Karnofsky Index <80% or Eastern Cooperative Oncology Group (ECOG) >2 5. Pre-treatment with murine antibodies, severe organ impairment (heart, lung, neck) according to common criteria 6. Pre-treatment with any chemotherapy
Date of first enrolment	01/09/2000
Date of final enrolment	31/03/2006

Im Neuenheimer Feld 410

Heidelberg
69120
Germany

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No