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Monoclonal Antibodies

ADCT-301 for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By David Rizzieri

Research Sponsored by David Rizzieri, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study, up to 3 years

Awards & highlights

Study Summary

This trial is testing a new drug, ADCT-301, to see if it is safe and effective for patients who have had an allogeneic transplant. The study will involve administering the drug on three occasions and taking blood tests afterwards, as well as a bone marrow biopsy at the end of cycle 2. Patients will be followed for up to a year after the trial to see how they respond to the drug. There are some risks associated with the drug, including decreased blood cell count, weight loss, and Guillain-Barre syndrome, where the immune system attacks and damages nerves.

Eligible Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Morphologic complete response rate of ADCT-301

Safety of ADCT-301

Trial Design

1Treatment groups

Experimental Treatment

Group I: ADCT-301 InfusionExperimental Treatment1 Intervention

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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Who is running the clinical trial?

David Rizzieri, MDLead Sponsor

11 Previous Clinical Trials

635 Total Patients Enrolled

ADC Therapeutics S.A.Industry Sponsor

28 Previous Clinical Trials

2,294 Total Patients Enrolled

Gwynn Long, M.D.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are receiving treatment in this trial?

"Confirmed, clinicaltrials.gov has the trial listed as actively recruiting with 10 participants needed from 1 site. The original post date was December 7th 2021 and it was last updated on January 10th 2022."

Answered by AI

Are there still vacancies for prospective participants of this clinical examination?

"Current information on clinicaltrials.gov confirms that this trial is presently recruiting patients. The protocol was initially made available to the public on December 7th 2021, and updated recently in January 10th 2022."

Answered by AI

What potential risks are associated with the use of ADCT-301?

"Our team at Power has assigned ADCT-301 a score of 2, which reflects the Phase 2 status of this medication as there is evidence to support its safety but not yet efficacy."

Answered by AI

Could you elucidate on the past studies conducted utilizing ADCT-301?

"Presently, there are 3 ongoing trials for ADCT-301 that have yet to reach Phase 3. These clinical studies span 88 branches across the United States with most being concentrated in Durham, North carolina."

Answered by AI

Is this investigation a pioneering endeavor?

"Currently, 30 cities and 11 countries are hosting 3 active trials of the drug ADCT-301. The first investigation into this medication began in 2018 under ADC Therapeutics S.A., involving 95 patients that successfully completed Phase 1 FDA approval. Subsequently, one study has concluded since then."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Gwynn Long, M.D. 2021. "ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639024.