RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Quick Facts

Study Start:2020-08-07
Study Completion:2027-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04227847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Seagen Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
ONeal Comprehensive Cancer Center at UAB
Birmingham, Alabama, 35294
United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, 91010
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
UCLA Department of Medicine - Hematology & Oncology
Los Angeles, California, 90095
United States
UCLA Hematology-Oncology Clinic
Los Angeles, California, 90095
United States
Colorado Blood Cancer Institute, Lab
Denver, Colorado, 80218
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Presbyterian/St. Luke's Medical Center
Denver, Colorado, 80218
United States
The University of Kansas Cancer Center ,Investigational Drug Services
Fairway, Kansas, 66205
United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
United States
The University of Kansas Hospital
Kansas City, Kansas, 66160
United States
University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, 66160
United States
University of Kansas Medical center Medical office building
Kansas City, Kansas, 66160
United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, 66210
United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, 66211
United States
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
Louisville, Kentucky, 40207
United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
United States
Norton Women & Children's Hospital
Louisville, Kentucky, 40207
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
United States
The University of Kansas Cancer Center - Medical Oncology Clinic
Kansas City, Missouri, 64116
United States
The University of Kansas Cancer Center - Radiation Oncology Clinic
Kansas City, Missouri, 64116
United States
The University of Kansas Cancer Center -North
Kansas City, Missouri, 64154
United States
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
United States
San Juan Oncology Associates
Farmington, New Mexico, 87401
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
CUIMC Research Pharmacy
New York, New York, 10032
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
James Cancer Hospital / Ohio State University
Columbus, Ohio, 43210
United States
The Ohio State University Wexner Medical Center/James Cancer Hospital
Columbus, Ohio, 43210
United States
Hollings Cancer Center
Charleston, South Carolina, 29425
United States
Medical University of South Carolina- Ashley River Tower
Charleston, South Carolina, 29425
United States
Medical University of South Carolina- Investigational Drug Services
Charleston, South Carolina, 29425
United States
Medical University of South Carolina- University Hospital
Charleston, South Carolina, 29425
United States
St. Francis Hospital
Greenville, South Carolina, 29601
United States
St. Francis Cancer Center
Greenville, South Carolina, 29607
United States
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas, Texas, 75246
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-07
Study Completion Date2027-04-15

Study Record Updates

Study Start Date2020-08-07
Study Completion Date2027-04-15

Terms related to this study

Keywords Provided by Researchers

  • Seattle Genetics

Additional Relevant MeSH Terms

  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia