Posted by on Mar 26, 2019 in Hodgkin's lymphoma | 0 comments

In a nutshell

This trial is investigating the effects of AVD [doxorubicin (Adriamycin), vinblastine (Velban), and dacarbazine (DTIC)] with brentuximab vedotin (Adcetris) induction chemotherapy, plus nivolumab (Opdivo) for Hodgkin lymphoma (HL). The main outcome to be measured is survival without cancer worsening 3 years after treatment.

The details

There are many different treatments and combinations of treatments for Hodgkin lymphoma (HL). AVD is a common chemotherapy combination for the treatment of HL. There are new types of anti-cancer drugs called targeted therapies. These therapies kill tumor cells specifically. Brentuximab vedotin and nivolumab are two targeted therapies used for HL. It is important to investigate the effects of different combinations of treatments for HL.

This trial is investigating the effects of AVD with brentuximab vedotin induction chemotherapy, plus nivolumab for HL. The main outcome measured will be survival without cancer worsening.

Who are they looking for?

82 previously untreated patients will be enrolled in this study. Participants must have adequate blood cell counts and liver and kidney function tests. To participate, individuals must not be pregnant and must agree to use adequate contraception if sexually active.

Patients who have been exposed to radiation cannot participate. Those with liver failure or any other illness which may interfere with treatment may not participate. Those receiving treatment with any other anti-cancer drug will not be included. Those who have experienced allergic reactions to study drug constituents cannot be enrolled.

How will it work

All patients will receive AVD therapy on days 1 and 15. This will be repeated every 28 days unless the patient experiences cancer worsening or severe side-effects for 3 cycles. Patients who are HL positive will then receive brentuximab vedotin and nivolumab on day 1. This will be repeated every 2 weeks for 4 cycles unless the patient experiences cancer worsening or severe side effects. Then, patients who are HL positive will receive nivolumab on day 1. This will be repeated every 2 weeks for 8 cycles unless the patient experiences cancer worsening or severe side effects.  

Patients who are HL negative will receive nivolumab after AVD and brentuximab vedotin treatment. This will be repeated every 2 weeks for 8 cycles unless the patient experiences cancer worsening or severe side-effects for 3 cycles. Survival and side-effects will be studied for 3 years.

Clinical trial locations

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Type:Interventional
Participants:82
Study ID:NCT03233347
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