RECRUITING

Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)

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Conditions

Acute Myeloid LeukemiaAcute Lymphoid LeukemiaMixed Phenotype Acute LeukemiaAcute Undifferentiated LeukemiaChronic Myeloid Leukemia in Myeloid Blast CrisisChronic Myeloid Leukemia in Lymphoid Blast Crisis (Diagnosis)Chronic Myeloid Leukemia - Accelerated Phasehematologic malignanciesOrca-Qhematopoietic cell transplantengineered donor graftpediatrics

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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 is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q). The study will assess safety and efficacy of Orca-Q in pediatric patients with hematologic malignancies.

Official Title

Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT) Recipients With Hematologic Malignancies (HM)

Quick Facts

Study Start:2022-08-16
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05322850

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:Not specified to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, 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

Alexandra Leggett, MS
CONTACT
352-273-9785
PMO@cancer.ufl.edu

Principal Investigator

Jordan Milner, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32608
United States
University of Miami
Miami, Florida, 33136
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Jordan Milner, MD, PRINCIPAL_INVESTIGATOR, University of Florida

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 Date2022-08-16
Study Completion Date2027-09

Study Record Updates

Study Start Date2022-08-16
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • hematologic malignancies
  • Orca-Q
  • hematopoietic cell transplant
  • engineered donor graft
  • pediatrics

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Acute Lymphoid Leukemia
  • Mixed Phenotype Acute Leukemia
  • Acute Undifferentiated Leukemia
  • Chronic Myeloid Leukemia in Myeloid Blast Crisis
  • Chronic Myeloid Leukemia in Lymphoid Blast Crisis (Diagnosis)
  • Chronic Myeloid Leukemia - Accelerated Phase