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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Graft versus host disease following allogeneic stem cell transplantation
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.
Acute graft-versus-host disease (aGvHD) is a serious complication of stem cell transplantation where the donated stem cells view the recipient’s body as foreign and attack the body. This is normally managed with steroids but some patients don’t respond well to treatment. Identification of new safe and effective treatments for resistant aGVHD is very important.
Patients with aGVHD respond differently to treatment. Evidence from research carried out in the US and Germany has shown that blood tests can identify patients with high-risk aGvHD who might respond less well to treatment.
GM-CSF (granulocyte monocyte-colony stimulating factor) is a protein that controls the growth of blood cells and has recently been shown to be important in the development of acute GvHD. Lenzilumab is an antibody that targets GM-CSF and blocks its activity. Lenzilumab has been used successfully for the treatment of other diseases but has not been tested previously for treating aGvHD.
The aim of this study is to find out how effective and safe lenzilumab is for treating patients with high-risk aGvHD. The researchers will be looking at whether the drug is safe, the effects lenzilumab has on aGVHD, and how long these effects last.
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:
You can take part if:
You may not be able to take part if:
All Cohorts:1. Any additional treatment for GvHD excluding continuance of current prophylaxis or re-institution of drugs previously used for prophylaxis2. Patients requiring treatment with topical steroids only3. Known HIV or active hepatitis B/C (currently receiving treatment)4. Patients treated with >4 days of steroids for aGvHD (maximum of 20 mg for other indications)5. Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before registration/randomisation
Stage 1 and Stage 2 - Randomised Cohort:1. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Miss
Rebecca
Collings
+44 (0)121 371 7868
RATinG@trials.bham.ac.uk
The study is sponsored by University of Birmingham and funded by Leukaemia UK; The IMPACT network (UK); Humaingen, Inc..
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Or CPMS 51332
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