RECRUITING

Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies

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Conditions

Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS

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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 Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.

Official Title

Multi-institutional Prospective Phase I Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies

Quick Facts

Study Start:2015-01-01
Study Completion:2027-06-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02203903

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:6 Months to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have undergone eligibility evaluation as per FDA regulations outlined in 21 CFR 1271 subpart C. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for TAA-T generation provided that there are no new reasons for ineligibility since the transplant donor evaluation.
  2. * Aged 6 months to 80 years.
  3. * Donor or guardian of pediatric capable of providing informed consent.
  4. * Donor must have completed infectious Disease (ID) testing up to 7 days before or after the collection of blood from the donor (related or unrelated) for TAA-T manufacturing. The following tests will be performed:
  5. * HBsAg
  6. * HB Core antibody
  7. * HIV1/2 NAT
  8. * Syphilis (T. Pallidum IgG)
  9. * HTLV I/II
  10. * CMV total
  11. * HBV/HCV NAT
  12. * West Nile Virus NAT.
  13. * Cruz (Chagas) antibody
  14. * Hepatitis C
  15. * Female donors of childbearing age must have a negative pregnancy test within 7 days of blood collection for TAA-T manufacturing.
  1. * Donation of cells would pose a physical or psychological risk to the donor.
  2. * Female donors of childbearing age who are known to be pregnant.

Contacts and Locations

Study Contact

Fahmida Hoq, MBBS, MS
CONTACT
202-476-3634
fhoq@childrensnational.org

Study Locations (Sites)

Childrens National Medical Center
Washington, District of Columbia, 20010
United States
Tania Jain, MD
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Catherine Bollard

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 Date2015-01-01
Study Completion Date2027-06-28

Study Record Updates

Study Start Date2015-01-01
Study Completion Date2027-06-28

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS