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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2024
  • participants needed
    10
  • sponsor
    Gwynn Long, M.D.
Updated on 25 March 2022
cell transplantation
leukemia
gilbert's syndrome
hydrea

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.

Details
Condition Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm (MDS/MPN)
Treatment ADCT-301
Clinical Study IdentifierNCT04639024
SponsorGwynn Long, M.D.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients ≧ 18 years of age with persistence or relapse/progression AML, MDS
or MDS/MPN
following allogeneic stem cell transplantation
grade 1 overall GVHD at time of inclusion with stable immune suppression for at least 2 weeks pre infusion on study and planned stable immune suppression dose for at least 8 weeks (the safety evaluation period)
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 hould 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

Patients with progressive infections at time of first infusion (patients with treated infections documented as controlled by the treating team are eligible)
Known active CNS disease at time of enrollment
Patients with other cancers treated within 3 years
Known history of immunogenicity or hypersensitivity to a CD25 antibody or a component of ADCT-301
Major surgery, chemotherapy, systemic therapy (excluding hydroxyurea, steroids, and any targeted small molecules or biologics), or radiotherapy within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1, Day 1 treatment, except if approved by Dr. Rizzieri
Patients with proven, progressive severe autoimmune disease such as multiple sclerosis, active Guillain Barré syndrome, poliomyelitis, sjogren's are not eligible. Given the immediate, life threatening nature of the relapsed cancer in this patient population, those with other stable and non-immediate non-threatening autoimmune disorders such as thyroid disease or diabetes and others are eligible
Patients with a known infection/reactivation of any of the following within 28 days of the first dose of this agent on study are not eligible: HSV1, HSV2, VZV, EBV, CMV, measles, influenza A, Zika, Chikungunya, mycoplasma pneumonia, Campylobacter jejuni, enterovirus B68, or SARS-CoV-2. Patients will have evaluation for HSV1, HSV2, VZV, EBV, CMV as part of screening studies. Patients will have SARS-CoV-2 screening performed if at all possible during the screening process. If screening is not available, then screening based on symptoms will be documented. Additionally, screening based on clinical concern and/or symptoms will be conducted for measles, influenza A, Zika, Chikungunya, mycoplasma pneumonia, Campylobacter jejuni, enterovirus B68
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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