This is research study to find out if a drug called ADCT-301 is safe and to look at how patients respond to the study drug after an allogeneic transplantation. ADCT-301 will be administered on Days 1, 8 and 15 with blood tests following study drug infusion. Patients will have a bone marrow biopsy at the end of cycle 2/before cycle 3 to see how they are responding to the study drug. Patients will be followed for approximately every 12 weeks from the last disease assessment for up to 1 year from completion of therapy. There are risks to this study drug. Some risks include: decrease in certain blood cells, weight loss, loss of appetite, rash and Guillain-Barre syndrome, where the immune system attacks and damages nerves.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
Duke University Health System
Durham, North Carolina, United States
Number of Participants With Complete Remission (CR) or Complete Remission With Incomplete Count Recovery (CRi)
Participants were considered evaluable for efficacy if they were eligible and received at least one dose of the study agent and 2 cycles of therapy unless they withdraw early for safety.
Time frame: duration of study, up to approximately 11 months
Safety of ADCT-301 as Measured by Number of Participants With Unacceptable (Dose Limiting) Toxicities
Time frame: up to 12 weeks after the last dose (up to 7 months in total)
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