How to get involved

If you think your child may be eligible to enter the trial, you should first talk to your child’s oncologist at their next hospital visit about how to be involved.

It may be that your child will need to be referred to a different hospital to take part in the trial.

Who can enter the trial? 

The groups of patients in each treatment arm are as follows:

Treatment Arm I (Bispecific Antibodies (BsAb)):

is for children, adolescents and young people with relapsed/refractory B-NHL in first relapse (only one prior line of therapy) or subsequent relapse (more than one prior line of therapy), including those achieving insufficient response (partial response (PR), Stable disease (SD), or progressive disease (PD)) to ADC therapy with standard chemotherapy to progress to transplantation or those without available CAR T-cells. 

Treatment arm II (Antibody-Drug Conjugates (ADC) with standard chemotherapy):

is for children, adolescents and young people with relapsed/refractory B-NHL in first relapse (only one prior line of therapy) or subsequent (more than one prior line of therapy) relapse, including those achieving insufficient response  to BsAb therapy to progress to transplantation or those without available CAR T-cells. 

Treatment arm III (Chimeric Antigen Receptor (CAR) T-cells):

is for children, adolescents and young people with relapsed/refractory B-NHL who have had insufficient response (PR, SD, PD) to prior therapy to progress to transplantation and have CAR T-cell product available.

If your child falls into one of the above groups, they must also meet all of the below criteria (which your child’s oncologist will determine):

  • Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma/Leukemia or atypical Burkitt/Burkitt-like lymphoma, primary mediastinal large B-cell lymphoma (PMLBL) and mature B-NHL/Not Otherwise Specified (NOS)) at initial diagnosis
  • Radiologically and/or histologically proven B-NHL in first relapse (only one prior line of therapy) or subsequent relapse (more than one prior line of therapy) or refractory B-NHL
  • Aged 6 months to 25 years old at the time of trial registration
  • Medically fit to receive treatment (meets the minimum requirements for bone marrow function, liver function and kidney function listed in the trial protocol)
  • Life expectancy of more than 8 weeks
  • Evaluable disease as per the international paediatric NHL response criteria

Your child must also not meet any of the following criteria (which your child’s oncologist will determine):

  • B-cell Acute Lymphoblastic Leukaemia (B-ALL)/B-cell Lymphoblastic Lymphoma (B-LBL)
  • Patients within 90 days of any HSCT procedure
  • Patients within 42 days of any CAR T-cell therapy or other cellular therapies 
  • Patients who are pregnant or breastfeeding
  • Patients who cannot regularly be followed up due to psychological, social, geographical or other issues
  • Patients for whom non-compliance with treatment or trial procedures is expected
  • Uncontrolled concomitant infection
  • Positive HIV serology
  • Severe active viral infection, especially hepatitis B and/or C
  • Hepatitis B carrier status history of Hepatitis B Virus or positive serology
  • Previous investigational treatment within 14 days of first dose
  • Live vaccine within 28 days prior to trial entry 
  • Known history of hypersensitivity to any of the treatments or excipients

How many patients are needed? 

The trial is aiming to recruit up to 30 patients in each treatment arm. Some treatment arms may fill up faster than others. Once a treatment arm is full, a new medicine of the same type will take its place.

A group called the Trial Steering Committee will review the trial data at certain points, and may decide to pause recruitment, or remove a medicine, if it does not appear to be working to help the children in the trial. If this happens, a new medicine will replace it.

As the trial goes on, the research team may identify other types of treatment that they think may work for children with relapsed/refractory B-NHL. If this happens, new treatment arms could be added to the trial.

 

Which hospitals are running the trial? 

The Glo-BNHL trial is currently recruiting hospitals to take part. Our hope is that we will be able to open in hospitals around the world to give all children with relapsed/refractory B-NHL the opportunity to receive new treatments that may help them. Initially we will be opening the trial in Europe, North America, Australasia, and the Middle East, however new countries will be added later.