ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN
NCT04639024 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2026-05-01
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
- Acute Myeloid Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Myeloproliferative Neoplasm (MDS/MPN)
Interventions
- DRUG
-
ADCT-301
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.
Sponsors & Collaborators
-
ADC Therapeutics S.A.
collaborator INDUSTRY -
Gwynn Long, M.D.
lead OTHER
Principal Investigators
-
Gwynn Long, M.D. · Professor of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-07
- Primary Completion
- 2022-11-03
- Completion
- 2022-11-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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