- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04639024
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADCT-301 Infusion
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphologic complete response rate of ADCT-301
Time Frame: End of Study, up to 3 years
|
Investigator report; efficacy rule
|
End of Study, up to 3 years
|
Safety of ADCT-301
Time Frame: up to 12 weeks (84 days) after the last dose
|
Number of adverse events as measured by self report
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up to 12 weeks (84 days) after the last dose
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gwynn Long, M.D., Professor of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00105771
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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