Phase I Trial of Brentuximab Vedotin for Steroid Refractory Acute Graft vs. Host Disease (GvHD)
This study will be broken up into two parts: induction and maintenance. The induction phase
will last for 28 days and the maintenance phase will last for 12 weeks.
Since we are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants that have Graft vs. Host
Disease, not everyone who participates in this research study will receive the same dose of
the study drug. The dose you get will depend on the number of participants who have been
enrolled in the study before you and how well they have tolerated their doses.
The induction phase of the trial involves finding the safest dose of brentuximab vedotin. In
this phase, participants will receive 3 weekly doses on days 1, 8 and 15 of the cycle.
Brentuximab vedotin is administered via intravenous infusion, which means directly into the
vein, over a period of about 30 minutes.
Additionally you will undergo the following tests and procedures when you come into the
clinic to receive your brentuximab vedotin: physical exam, medical history, performance
status, routine and research blood tests, assessment for side effects and acute/chronic
If you are still on this study at the end of the induction phase, meaning you have had no
serious side effects and your GVHD has not progressed, ou wil continue to the next phase of
Participants in the maintenance phase will receive a total of 4 doses of brentuximab vedotin
every 3 weeks for a total of 12 weeks. Day 1 of the maintenance phase will be the day after
the 28 day induction phase ends. You will receive a dose of brentuximab vedotin via IV
infusion on Day 1 of Weeks 1,4, 7 and 10. During these visits you will undergo the same
tests, procedures and assessments as the induction phase.
You will have three follow up visits after your last dose of brentuximab vedotin at 6
months, 9 months and 12 months after the end of the maintenance phase. You also have the
option to talk to your physician about continuing treatment with brentuximab vedotin.
However, brentuximab vedotin will only be provided by the study for the 12 week maintenance
period. Afterward, brentuximab vedotin will need to be covered by your insurance or paid for
out of pocket.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Define MTD of Brentuximab Vedotin
To define the maximum tolerated dose (MTD) of brentuximab vedotin when given as treatment for steroid-refractory acute GVHD
Yi-Bin Chen, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|