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Delphinus: a phase 2 study of the antibody daratumumab in children and young adults (1–30 years old) with relapsed or refractory B-cell or T-cell lymphoblastic lymphoma

This summary is for people with lymphoma, but this trial is also recruiting people with acute lymphoblastic leukaemia.

Note: This is a trial in children and young people aged between 1 and 30. The information here is aimed at young people with lymphoma. You may also find this information useful if you are a parent or carer of a child with lymphoma.


Purpose of trial

The aim of this trial is to find out whether it is safe and effective to add daratumumab to standard salvage chemotherapy (chemotherapy given when standard chemotherapy has not been successful) in children and young adults with B-cell or T-cell lymphoblastic lymphomas who have not responded to previous treatment or whose lymphoma has come back (relapsed) after previous treatment.


Treatments

Daratumumab is an antibody therapy. It is already used to treat some types of blood cancer.

Daratumumab sticks to a protein called CD38, which is found on the surface of many white blood cells, including lymphoma cells. When daratumumab sticks to CD38, it activates your own immune system to destroy the lymphoma cell.

In this study, you are told what treatment you are having and given information about it. The treatment, and how long you have it, is different depending on whether you have B-cell or T-cell lymphoblastic lymphoma.

B-cell group

If you have B-cell lymphoblastic lymphoma, you are given:

  • daratumumab, given intravenously (by a drip into a vein)
  • vincristine, a chemotherapy drug, given intravenously (by injection into a vein)
  • methotrexate, a chemotherapy drug, given intrathecally (by injection into the fluid around the spinal cord)
  • prednisolone, a steroid, given by mouth or by injection into a vein.

The treatment is given in cycles (a block of treatment followed by a rest before the next block). Each cycle is 28 days.

You carry on having the treatment as long as it is benefiting you. Your study doctor will check how your lymphoma is responding. If you have a complete response (no evidence of lymphoma), you might be able to stop the treatment and have a stem cell transplant to help keep your lymphoma under control. 

If your lymphoma gets worse or you have troublesome side effects, you will stop this treatment and your doctor will discuss other treatment options with you.

T-cell group

If you have T-cell lymphoblastic lymphoma, you have two cycles of treatment, where you have a block of chemotherapy followed by a rest.

The first cycle includes:

  • daratumumab, given intravenously (by a drip into a vein)
  • three chemotherapy drugs: vincristine, doxorubicin and peg-asparaginase, all given intravenously (by injection into a vein)
  • methotrexate, a chemotherapy drug, given intrathecally (by injection into the fluid around the spinal cord)
  • prednisolone, a steroid, given by mouth or by injection into a vein.

The second cycle includes:

  • daratumumab given intravenously
  • four chemotherapy drugs: cyclophosphamide, cytarabine and methotrexate given intravenously, and 6-mercaptopurine given by mouth.

You finish the treatment after the second cycle.


Who can enter

Your consultant can give you advice on whether you might be suitable for this trial.

Around 10 people are needed for this trial.

You may be able to enter if:

  • You have T-cell lymphoblastic lymphoma or B-cell lymphoblastic lymphoma.
  • You have previously had at least one (for T-cell lymphoblastic lymphoma) or two (for B-cell lymphoblastic lymphoma) courses of treatment for your lymphoma but either did not respond (refractory lymphoma) or your lymphoma came back (relapsed).
  • Your lymphoma has been proven with a biopsy.
  • Your lymphoma is measurable on scans.
  • You are between 1 and 30 years old.
  • You are well enough to take part in the trial.
  • Your blood and other health test results are satisfactory.

You won’t be able to enter if:

  • You’ve had an allogeneic (donor) stem cell transplant in the last 3 months.
  • You have acute graft-versus-host disease.
  • You have moderate or severe chronic graft-versus-host disease.
  • You’ve had treatment to suppress your immune system after a stem cell transplant in the last month.
  • You get breathless at rest or have low oxygen levels in your blood.
  • You’ve had asthma in the past 2 years.
  • You are being treated in another clinical trial.
  • You’ve had another experimental treatment in the last 4 weeks.
  • You’ve had a live vaccine in the last 4 weeks.

Further information

More information about this trial is available at www.clinicaltrials.gov/ct2/show/NCT03384654.

A link to screen potential participants is available at https://jnj-pam.sylogent.com/scr/Home.aspx?CR108432