A trial looking at chemotherapy and rituximab for non Hodgkin lymphoma (R-CODOX-M/R-IVAC)
Cancer type:
Status:
Phase:
This trial looked at the combination of rituximab with CODOX-M and IVAC chemotherapy, for diffuse large
The trial was open for people to join between 2008 and 2013. The team published the results in 2020.
More about this trial
This trial was for people with diffuse large B cell lymphoma (DLBCL) that had a high risk of coming back after treatment.
When this trial was done, the standard treatment for DLBCL was R-CHOP. This is a combination of:
- a monoclonal antibody called rituximab
- the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine
- the steroid prednisolone
In this trial they were looking at a combination called R-CODOX-M/R-IVAC. They hoped this would work better than R-CHOP.
R-CODOX-M is a combination of rituximab with the chemotherapy drugs cyclophosphamide, cytarabine, vincristine, doxorubicin and methotrexate.
R-IVAC is the combination of rituximab with the chemotherapy drugs etoposide, ifosfamide and cytarabine.
There is information about the drugs listed above in our Cancer drugs section.
The main aims of this trial were to find out:
- how well R-CODOX-M/R-IVAC works for people with diffuse large B cell NHL
- more about the side effects
Summary of results
This trial showed that R-CODOX-M/R-IVAC might be useful treatment for some people with high risk diffuse large B cell lymphoma.
Results
A total of 111 people joined this trial. Everyone taking part had the same treatment:
- 2 cycles of R-CODOX-M and
- 2 cycles of R-IVAC
A total of 85 people had all 4 cycles of treatment.
The research team looked at how many people’s lymphoma had not come back, 2 years after joining the trial. They found it was nearly 7 out of 10 people (68%).
They also looked at how many people were living, 2 years after joining the trial. They found it was nearly 8 out of 10 people (76%).
This is about the same, or perhaps a little better, than you might expect with R-CHOP.
When the team looked at the results in more detail, they found the lymphoma came back in more people who were:
- over 50 years old
- less fit and well before treatment
Side effects
Everyone taking part had at least one side effect from treatment. Some were mild or didn’t last long. But most people (88%) had at least one that was more severe.
The most common of these side effects were:
- a drop in
white blood cells - a drop in blood clotting cells (platelets)
- infection
- sore mouth (mucositis)
Five people who took part died because of side effects they had. Three people had a serious infection caused by a severe drop in white blood cells (neutropenic sepsis). And two people had serious bleeding problems, one in the brain and one in the bowel. All of the people who died were over 50 and less fit and well before they started treatment.
This is a bit higher than you would expect in people having R-CHOP. But about the same as it is for people having other more intensive treatments similar to R-CODOX-M/R-IVAC.
Conclusion
The trial team concluded that R-CODOX-M/R-IVAC worked well for younger, fitter people with high risk diffuse large B cell lymphoma.
Everyone in this trial had the same treatment. This makes it harder to draw firm conclusions about how well it works. The team suggest more trials are done which compare this treatment to the standard treatment already being used.
More detailed information
There is more information about this research in the reference below.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.
Favourable outcomes for high-risk diffuse large B-cell lymphoma (IPI 3–5) treated with front-line R-CODOX-M/R-IVAC chemotherapy: results of a phase 2 UK NCRI trial
A.K McMillan and others
Annals of Oncology, 2020. Volume 31, issue 9, pages 1251 – 1259.
Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Andrew McMillan
Supported by
Bloodwise
Experimental Cancer Medicine Centre (ECMC)
Haematology Trials Group
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040