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A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
NCT04227847 · View on ClinicalTrials.gov ↗
Study Summary
This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have seven groups or "parts." * Part A will find out how much SEA-CD70 should be given to participants * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS. * Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to participants * Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML that has not been treated. * Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG azacitidine
- DRUG SEA-CD70
Study Locations (20)
Kansas
- The University of Kansas Cancer Center ,Investigational Drug Services — Fairway
- The University of Kansas Clinical Research Center — Fairway
- The University of Kansas Hospital — Kansas City
- University of Kansas Hospital Cambridge North Tower A — Kansas City
- University of Kansas Medical center Medical office building — Kansas City
- University of Kansas Medical Center Research Institute — Kansas City
- The University of Kansas Cancer Center - Overland Park — Overland Park
- The University of Kansas Cancer Center - Indian Creek Campus — Overland Park
- The University of Kansas Cancer Center — Westwood
California
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte
- IP Address: City of Hope Investigational Drug Services(IDS) — Duarte
- Ronald Reagan UCLA Medical Center — Los Angeles
- UCLA Hematology-Oncology Clinic — Los Angeles
Alabama
- University of Alabama at Birmingham — Birmingham
- University of Alabama at Birmingham — Birmingham
- Dept. of Medicine, UAB ONeal Comprehensive Cancer Center — Birmingham
Colorado
- Colorado Blood Cancer Institute, Lab — Denver
- Colorado Blood Cancer Institute — Denver
- Presbyterian/St. Luke's Medical Center — Denver
Kentucky
- Norton Hospitals, Inc — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2028-07-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04227847
The ClinicalTrials.gov registry entry for NCT04227847 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04227847 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Kansas, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04227847 about?
NCT04227847 is a clinical study titled "A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies". This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is...
What is the current status of trial NCT04227847?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 178 participants. The study started on 2020-08-07. Estimated completion is 2028-07-03.
What conditions does trial NCT04227847 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04227847?
The interventions under investigation include: Venetoclax (DRUG), azacitidine (DRUG), SEA-CD70 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04227847?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04227847 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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