Randomized Phase III trial: Maintenance therapy with the monoclonal chimeric antibody rituximab compared to observation in patients with CD20+ B-cell Non-Hodgkins lymphoma

ISRCTN	ISRCTN74547745
DOI	https://doi.org/10.1186/ISRCTN74547745
Protocol serial number	HD2002 Rituximab maintenance
Sponsor	University of Heidelberg (Germany) and Roche (Switzerland)
Funder	Roche (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Anthony D. Ho
Scientific

INF 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	Randomized Phase III trial: Maintenance therapy with the monoclonal chimeric antibody rituximab compared to observation in patients with CD20+ B-cell Non-Hodgkins lymphoma
Study acronym	HD2002 Rituximab maintenance
Study objectives	The objective of this trial is to examine whether event free survival, overall survival and cure rate of patients with CD20+ B-cell Non-Hodgkins lymphoma can be improved by a maintenance therapy of 8 cycles rituximab q 3 months (total 24 months). The hypothesis is that residual tumor cells can be destroyed in vivo by the rituximab maintenance therapy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	B-cell lymphoma
Intervention	Rituximab maintenance compared to observation
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	Rituximab
Primary outcome measure(s)	Event-free survival
Key secondary outcome measure(s)	Overall survival, progression-free survival
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	174
Key inclusion criteria	1. B-cell CD20+ Non-Hodgkins Lymphoma (primary therapy and relapse). At study entry patients with agressive lymphoma need to have a complete remission, if a residual tumor is still present a positron-emission-tomography examination needs to reveal no active tumor. Patients with indolent lymphoma need at least a partial remission to enter this trial 2. Age above 18 years 3. Karnofsky Index above 60 4. Contraception and negative pregnancy test of women in reproducitve age 5. Valid patient approval
Key exclusion criteria	1. Manifest cardiac insufficiency 2. Chronic obstructive lung disease with hypoximia 3. Uncontrolled hypertension 4. Renal insufficiency (creatinine above 2 mg/dl) 5. Hepatic insufficiency (Bilirubin above 2.0 mg/dl) 6. Pregnancy 7. Breast feeding 8. Severe psychiatric illness 9. Human immunodeficiency virus (HIV) positive patients 10. Primary cerebral lymphoma 11. Previous allogeneic transplant
Date of first enrolment	24/06/2002
Date of final enrolment	31/12/2006

INF 410

Heidelberg
69120
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2015		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

27/11/2015: Publication reference added.