Phase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma

ISRCTN ISRCTN23628366
DOI https://doi.org/10.1186/ISRCTN23628366
ClinicalTrials.gov number NCT00005867
Secondary identifying numbers GOOD RISK
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
27/09/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-of-chemotherapy-for-people-over-60-with-aggressive-non-hodgkins-lymphoma

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePhase III Trial comparing CHOP to PmitCEBO in Good Risk patients with Histologically Aggressive Non-Hodgkin's Lymphoma
Study acronymNot Applicable
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLymphoma (non-Hodgkin's)
Intervention1. CHOP regimen: Chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisolone repeated every 21 days for 6-8 cycles
2. PmitCEBO regimen: Chemotherapy with mitoxantrone, cyclophosphamide, etoposide, bleomycin, vincristine and prednisolone. Repeated every 14 days for 4-8 cycles
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Various
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date10/12/1998
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupSenior
Lower age limit18 Years
Upper age limit59 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Previously untreated non-Hodgkin's Lymphoma of the following types: follicular large cell lymphoma, diffuse mixed cell lymphoma diffuse large cell lymphoma diffuse immunoblastic lymphoma 0r Revised European/American Lymphoma (REAL) classification: diffuse large B peripheral T cell lymphoma
2. Bulky stage IA and stages IB-IV (Ann Arbour staging system)
3. Age 18-59 years
4. Measurable or evaluable disease
5. Good prognosis, defined as the presence of no more than one of the following adverse features: Stage III/IV Lactic dehydrogenase (LDH) >upper limit of normal Performance status 2-4 (Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO]) Adequate bone marrow function, indicated by Haemoglobin ≥10 g/dL Neutrophils ≥2 x 10^9/L Platelets ≥100 x 10^9/L
6. Written informed consent
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment10/12/1998
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

British National Lymphoma Investigation (BNLI) (UK)
Charity

CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom

Phone +44 (0)20 7679 8060
Email bnli@ctc.ucl.ac.uk
Website http://www.bnli.ucl.ac.uk

Funders

Funder type

Research organisation

British National Lymphoma Investigation (BNLI) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/05/2009 Yes No

Editorial Notes

27/09/2019: ClinicalTrials.gov number added.