Condition category
Cancer
Date applied
12/09/2005
Date assigned
06/01/2006
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

Prof Anthony Ho

ORCID ID

Contact details

Im Neuenheimer Feld 410
Heidelberg
69120
Germany
+49 (0)6221 568001
sekretariat_ho@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HD2000

Study hypothesis

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

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

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 names

CHOP and Rituximab

Primary outcome measures

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.

Secondary outcome measures

1. Clinical remission rate
2. Duration of molecular and clinical response
3. Toxicity

Overall trial start date

01/09/2000

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/09/2000

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Im Neuenheimer Feld 410
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

Im Neuenheimer Feld 410
Heidelberg
69120
Germany
+49 (0)6221 568001
sekretariat_ho@med.uni-heidelberg.de

Sponsor type

University/education

Website

http://www.klinikum.uni-heidelberg.de/index.php?id=725

Funders

Funder type

Industry

Funder name

Sponsored and funded by Roche and University of Heidelberg

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22847344

Publication citations

  1. Results

    McClanahan F, Hielscher T, Rieger M, Hensel M, Bentz M, Schmidt-Wolf I, Käbisch A, Salwender H, Dürk H, Staiger H, Mandel T, Neben K, Hillengass J, Leo E, Krämer A, Ho AD, Witzens-Harig M, Final results of a randomized trial comparing 1, 3, or 6 infusions of Rituximab plus 6 cycles CHOP provide valuable preliminary data towards a more cost-effective and safer treatment of advanced follicular lymphoma., Am. J. Hematol., 2012, 87, 10, E68-71, doi: 10.1002/ajh.23286.

Additional files

Editorial Notes