A trial looking at chemotherapy and rituximab for people with newly diagnosed diffuse large B cell lymphoma who cannot have CHOP chemotherapy (R-GCVP)
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This trial looked at chemotherapy and rituximab for people who had just been diagnosed with diffuse large B cell lymphoma and who couldn’t have CHOP chemotherapy. This trial was supported by Cancer Research UK.
Diffuse large B cell lymphoma (DLBCL) is a type of high grade non Hodgkin lymphoma. Doctors often treat DLBCL with CHOP chemotherapy and a monoclonal antibody called rituximab. This combination of drugs is called R-CHOP.
One of the drugs included in the CHOP regime can cause damage to the heart. If people already have heart problems or they are very unfit, they can’t have this type of treatment.
Researchers were looking at a different combination of drugs, which might cause less damage to the heart. It included a chemotherapy drug called gemcitabine. In earlier trials, gemcitabine helped people with lymphoma who had already had other treatment. This trial was for people who had just been diagnosed with DLBCL and hadn’t had any treatment yet.
The aims of the trial were to
- Find out if this combination of chemotherapy drugs and rituximab helped people with DLBCL who couldn’t have CHOP chemotherapy
- Learn more about the side effects
Summary of results
The trial team found that using gemcitabine could help people with DLBCL who couldn’t have CHOP chemotherapy.
This was a phase 2 trial. It recruited 62 people. Everyone was to have rituximab, gemcitabine, cyclophosphamide, vincristine and prednisolone.
After they had finished treatment the researchers looked at how well their DLBCL had responded. They found that in
- 38 people the lymphoma had responded
- 4 the lymphoma had stayed the same
- 6 the lymphoma had continued to grow
Unfortunately 14 people had died and the researchers weren’t able to assess how well their lymphoma had responded. Of these 14 people, 3 had died because of heart problems.
The major side effects of treatment were
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Infection
- Tiredness
- A change to the way the heart worked
The trial team concluded that using gemcitabine was reasonably safe. And it could help people who wouldn’t be able to have CHOP chemotherapy because of heart problems.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (
) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.
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 Paul Fields
Supported by
Amgen
Cancer Research UK
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)
Haematological Malignancies Diagnostic Service (HMDS)
National Institute for Health Research Cancer Research Network (NCRN)
Roche
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUK/07/007.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
