Acute Myeloid Leukemia (AML)Phase 2NCT04639024
ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN
A Phase 2 study testing ADCT-301 in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Gwynn Long, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm (MDS/MPN)
- What is being tested?
- ADCT-301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 3 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
Official title: 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.
Read more
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)
- Being tested
- ADCT-301
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADCT-301Drug
Also called Camidanlumab tesirine
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.
| Study group | Role | What they receive |
|---|---|---|
| ADCT-301 Infusion | Experimental | 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. Receives: Drug: ADCT-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Remission (CR) or Complete Remission With Incomplete Count Recovery (CRi)
Participants were considered evaluable for efficacy if they were eligible and received at least one dose of the study agent and 2 cycles of therapy unless they withdraw early for safety.
Measured: duration of study, up to approximately 11 months
Safety of ADCT-301 as Measured by Number of Participants With Unacceptable (Dose Limiting) Toxicities
Measured: up to 12 weeks after the last dose (up to 7 months in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start7 Dec 2021
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Why it stopped: ADCT is reallocating all resources to the phase III program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gwynn Long, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Responsible party
- Sponsor-investigator, Gwynn Long, M.D., Duke University
- Investigators
- Gwynn Long, M.D., Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639024
- Sponsor's protocol ID
- Pro00105771
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2020
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04639024
- Acronym / sponsor ID
- Pro00105771
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm (MDS/MPN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ADCT is reallocating all resources to the phase III program.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Gwynn Long, M.D.University, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADCT-301 Infusion | Experimental | Drug: ADCT-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ≧ 18 years of age with persistence or relapse/progression AML, MDS, or MDS/MPN,
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADCT-301Also: Camidanlumab tesirinePatients 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. | Drug | ADCT-301 Infusion |
Primary outcome
Number of Participants With Complete Remission (CR) or Complete Remission With Incomplete Count Recovery (CRi)
Time frame: duration of study, up to approximately 11 months
Participants were considered evaluable for efficacy if they were eligible and received at least one dose of the study agent and 2 cycles of therapy unless they withdraw early for safety.
Safety of ADCT-301 as Measured by Number of Participants With Unacceptable (Dose Limiting) Toxicities
Time frame: up to 12 weeks after the last dose (up to 7 months in total)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwynn Long, M.D. principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADCT-301 in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Gwynn Long, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Remission (CR) or Complete Remission With Incomplete Count Recovery (CRi) (time frame: duration of study, up to approximately 11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.