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Contact Information:

Ms Anna McKeever
+44 (0)151 795 5293
petrea@liverpool.ac.uk


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Be Part of Research - Trial Details - Phase III evaluation of PET-guided, Response-Adapted therapy in patients with previously untreated, high tumour burden follicular lymphoma
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Phase III evaluation of PET-guided, Response-Adapted therapy in patients with previously untreated, high tumour burden follicular lymphoma

Recruiting

Open to: All Genders

Age: Adult

Sutton Glasgow Plymouth Blackpool London Wirral Leicester

Medical Conditions

Follicular lymphoma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

10 May 2018 31 Oct 2025

Interventional

Intervention Type : Other
Intervention Description : Patients are initially screened for eligibility. They will have a physical examination and blood tests including for HIV and hepatitis viruses. Patients will also undergo an ordinary body scan (CT scan), a PET scan (sometimes referred to as PET-CT scan) and a bone marrow biopsy. With the exception of the PET scan, these tests are routine and would take place outside of the trial. The purpose of doing them is get a good picture of the disease before treatment starts so the effect of the treatment can be properly assessed, and also to make sure that it is safe to give the treatment.

Patients who are recruited to the study will then receive one of three different types of R+chemo "induction" treatments (R-CVP, R-CHOP or BR) as determined by the local Principal Investigator. The purpose of induction treatment is to shrink down any lumps and put the patient into a remission. All 3 drug combinations are routinely used for the initial treatment of FL, and each has its advantages and disadvantages. Additional blood tests are required just before treatment is started to ensure that it is safe to give.

The induction treatment starts within 42 days of signing up for the study. It is usually given as an outpatient and consists of one round (or cycle) of treatment every 3 or 4 weeks for up to 6 or 8 cycles (i.e. 4-6 months in total). Depending on the local hospital’s policy, the rituximab may be given into a vein (takes several hours) or as an injection under the skin (takes several minutes) and is given on the first day of each cycle. The chemotherapy drugs are given into a vein over the first 1 or 2 days of each cycle. The R-CVP and R-CHOP induction treatments also include a 5-day course of steroid tablets.

Patients will receive paracetamol and antihistamine medication prior to each dose of rituximab to reduce the risk of flu-like symptoms and infusion reactions. They will also receive anti-sickness tablets and a drug called allopurinol to reduce the risk of kidney damage by chemicals released from the lymphoma cells as they break down. Some patients will also require growth factor injections to help the bone marrow work if the white blood cell count drops between treatment cycles or if they develop any infections. This is all standard practice.

In addition to attending for each cycle of treatment, patients will also have to visit for assessment before each cycle to make sure it is safe to go ahead with treatment. In some hospitals and treatment units the first and second visits can be rolled into one. The doctor may request a CT scan mid-way through treatment to make sure it is working. This is all standard practice.

At the end of the induction treatment, patients will have another CT scan (standard practice) and PET-CT scan (not yet standard practice everywhere but likely to become so). If the bone marrow was involved with lymphoma prior to starting treatment, another bone marrow biopsy will be requested if the pre-treatment bone marrow is clear to confirm that a "complete remission" has been obtained (standard practice).

Patients whose disease has shrunk by less than 50% on the ordinary CT scan (expected to be 5-10% of patients) will not have any further treatment as part of the trial and will be managed at the discretion of the Local Investigator.

Patients whose disease has shrunk by 50% or more on the CT scan will be separated into two groups depending on the results of the PET scan.

Patients who have a clear (negative) PET scan will be randomly allocated (1:1 ratio) to receive either rituximab maintenance 375 mg/m2 iv (or 1400 mg sc) on day 1 of each cycle, repeated every 8 weeks for up to 12 cycles, or no further treatment. Rituximab will be given in exactly the same way as it would be given outside the study and with paracetamol antihistamine (with or without steroid medication) prior to each dose to reduce the risk of flu-like symptoms and infusion reactions. Prior to each treatment, patients will have assessments to make sure it is safe to go ahead (patients allocated to receive no further treatment will also have assessments at the same time points). In some hospitals and treatment centres, the first and second visits can be rolled into one. To monitor the disease, patient will have a CT scan after 2 years and one every year thereafter until the study finishes.

Patients who have a positive PET scan at the end of the induction treatment (i.e. the disease is still visible) will be randomly allocated (1:1 ratio) to receive rituximab maintenance 375 mg/m2 iv (or 1400 mg sc) on day 1 of each cycle, repeated every 8 weeks for up to 12 cycles, either with or without lenalidomide, which is taken by mouth once daily on days 1 to 21 of every 28-day cycle (dose tailored to renal function and tolerance) for up to 24 cycles. Patients will also receive paracetamol and antihistamine prior to each dose of rituximab to reduce the risk of flu-like symptoms and infusion reactions. Patients receiving rituximab and lenalidomide will receive allopurinol to protect the kidneys from chemicals released from lymphoma cells as they break down plus a drug such as aspirin to prevent blood clots. Growth factor injections may also be given if necessary to stimulate the bone marrow.

In addition to attending for each cycle of treatment, patients will also have to visit for assessment before each cycle to make sure it is safe to go ahead. In some hospitals and treatment units the first and second visits can be rolled into one. To monitor disease, patients will have a CT scan every year plus a PET scan after 1 year to see if the scan is still positive or has become negative.

After the 2-year maintenance treatment period, patients will attend for formal follow-up visits every 6 months for as long as they remain in remission. They will have CT scans every year and their quality of life and levels of psychological stress will be measured.

As there is a lot of information for patients to take in about this study, we want to learn how we can improve our information and communication about research. With the patient’s permission, we will audio-record our discussions with patients in clinic as part of the patient’s informed consent process. A researcher may contact the patients afterwards to ask if they would be willing to take part in an interview about their views on the clinical study. Patients do not have to agree to take part in this interview if they choose not to.

Another aspect of this study involves assessing how the disease or any treatment patients receive affects their quality of life and stress levels, so they will complete a questionnaire that asks about how they feel and what activities they can undertake. This will be done before treatment starts and at intervals during and after treatment. They will also fill in another questionnaire to help calculate the costs of the study treatment to the NHS and with their permission we will retrieve information from their electronic medical records from NHS Digital.

Patients will have blood samples taken for standard blood tests every time they attend for treatment to tell if they are well enough for treatment. In addition, if they consent, further blood samples will be taken before the start of treatment and at other times in the study for use in scientific studies that will add to the study results. Patients can withdraw from providing these samples at any time.




You can take part if:



You may not be able to take part if:


1. Any serious medical condition that would prevent the subject from participating in the study2. Known active infection with HIV, HBV or HCV3. Pregnant or lactating females4. Central nervous system involvement as documented by spinal fluid cytology or imaging5. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer (TNM stage of T1a or T1b)6. Any of the following laboratory abnormalities:6.1. Absolute neutrophil count (ANC) < 1,000/ÎĽL (1.0 X 109/L)6.2. Platelet count < 50,000/ÎĽL (50 X 109/L)6.3. Serum alanine transaminase (ALT) > 3.0 x upper limit of normal (ULN)6.4. Serum total bilirubin > 1.5 x ULN unless due to Gilbert's Syndrome or biliary obstruction by lymphoma


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Marsden Hospital
    Downs Road
    Sutton
    SM2 5PT
  • Beatson West of Scotland Cancer Centre
    1053 Great Western Road
    Glasgow
    G12 0YN
  • Derriford Hospital
    Derriford Road
    Plymouth
    PL6 8DH
  • Blackpool Victoria Hospital
    Whinney Heys Road
    Blackpool
    FY3 8NR
  • Royal Marsden Hospital
    Fulham Road
    London
    SW3 6JJ
  • Clatterbridge Cancer Centre (lead site)
    Clatterbridge Road Bebington
    Wirral
    CH63 4JY
  • Leicester Royal Infirmary
    Hope Clinical Trials Unit Leicester Royal Infirmary
    Leicester
    LE1 5WW

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Ms Anna McKeever
+44 (0)151 795 5293
petrea@liverpool.ac.uk



The study is sponsored by University of Liverpool and funded by Cancer Research UK; Grant Codes: C18029/A21585.



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Read full details for Trial ID: ISRCTN86739591

Or CPMS 34767

Last updated 15 October 2024

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