TerminatedPhase 2

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

Stopped: ADCT is reallocating all resources to the phase III program.

United States3 participantsStarted 2021-12-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. following allogeneic stem cell transplantation.
✓. Calculated creatinine clearance ≥ 60ml/min as estimated by Cockcroft Gault and not dialysis dependent.
✓. AST, ALT \<3 x ULN unless documented due to medications (ie azole or other common therapy for such patients). Total bilirubin ≤3.0 mg/dl unless there is a history of Gilbert's syndrome in which case the T bili should be \< 5.0 mg/dl.
✓. Females cannot be pregnant or breast-feeding from time of enrollment till 16 weeks post final agent exposure on this study.
✓. Immune suppression not greater than 20mg prednisone daily or equivalent dosing of alternative GVHD prophylaxis/therapy
✓. Patients are at least 30 days from most recent allogeneic stem cell infusion
✓. Patients may have had other therapy post alloBMT and other donor lymphocyte infusions but they must be at least 60 days from the last infusion of cell therapy products
✓. Patients must have other anti-leukemia therapies stopped 2 weeks prior to infusion on this study. Hydrea or pheresis ARE allowed prior to this study and may continue until 14 days following the first infusion on this study if deemed to be needed to assist in count control.

Exclusion criteria

What they're measuring

Number of Participants With Complete Remission (CR) or Complete Remission With Incomplete Count Recovery (CRi)

Timeframe: duration of study, up to approximately 11 months

Safety of ADCT-301 as Measured by Number of Participants With Unacceptable (Dose Limiting) Toxicities

Timeframe: up to 12 weeks after the last dose (up to 7 months in total)

Trial details

NCT IDNCT04639024

SponsorGwynn Long, M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-03

Results submitted2023-10-31

View on ClinicalTrials.gov More Acute Myeloid Leukemia (AML) trials