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NCT04227847 · ClinicalTrials.gov registry record · Phase 1

A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

Recruiting
Registry status
Phase 1
Development phase
178
Enrollment target
20
Study locations

NCT04227847 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 178 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT04227847, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

RECRUITING
Registry status
Phase 1
Development phase
178 participants
Enrollment target
20
Study locations

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

Acute Myeloid Leukemia Myelodysplastic Syndrome

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

FieldValue
Enrollment Target 178 participants
Start Date 2020-08-07
Est. Completion 2028-07-03
Phase Phase 1

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

28 total trials

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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, categorized as Phase 1. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (55% higher). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.

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.

NCT04227847 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Kansas, California, Alabama.

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.

What interventions are being tested in trial NCT04227847?

The interventions under investigation include: Venetoclax (DRUG), azacitidine (DRUG), SEA-CD70 (DRUG).

Who is sponsoring clinical trial NCT04227847?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.

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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