Clinical Trials Directory

Trials / Terminated

TerminatedNCT04639024

ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN

An Open-label Pilot Study to Evaluate the Safety and Efficacy of ADCT-301 in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Myeloproliferative Neoplasms.

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Gwynn Long, M.D. · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGADCT-301Patients 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.

Timeline

Start date
2021-12-07
Primary completion
2022-11-03
Completion
2022-11-03
First posted
2020-11-20
Last updated
2023-05-12

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04639024. Inclusion in this directory is not an endorsement.