RECRUITING

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies

Talk to us

Conditions

Hematologic MalignancyHematopoietic Cell Transplant

Quick Navigation

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 phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI. The primary objective is: - To assess the safety and feasibility of early CD45RA-depleted DLI administration. The secondary objectives are * To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy. * To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.

Official Title

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies

Quick Facts

Study Start:2025-12
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07052370

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 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age less than or equal to 21 years
  2. * High risk hematologic malignancy whereas allogeneic transplantation is the current standard of care. This includes (but is not limited to):
  3. * High risk ALL in CR1 or CR2,
  4. * any ALL in CR3 or subsequent;
  5. * AML in high risk CR1 (AML diagnosis includes myeloid sarcoma),
  6. * any AML in CR2 or subsequent,
  7. * any therapy related AML;
  8. * MDS (primary or secondary),
  9. * NK cell, biphenotypic, or undifferentiated leukemia/lymphoma in CR1 or subsequent;
  10. * CML in accelerated phase, or in chronic phase with persistent molecular positivity or intolerance to tyrosine kinase inhibitor, or a history of blast crisis.
  11. * If prior CNS leukemia, it must be treated and in CNS CR
  12. * Left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25%
  13. * Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2
  14. * Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing
  15. * Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)
  16. * Bilirubin ≤ 3 times the upper limit of normal for age
  17. * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age
  18. * At least single haplotype matched (≥ 4 of 8) family member
  19. * At least 18 years of age
  20. * HIV negative
  21. * Regarding donation eligibility, is identified as either:
  22. * Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
  23. * Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
  1. * Has a suitable HLA-identical sibling or suitable 12/12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame.
  2. * Any other active malignancy other than the one for which this HCT is indicated
  3. * Received a prior allogeneic HCT at any time
  4. * Received an autologous HCT within the previous 6 months
  5. * Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment
  6. * Breast feeding
  7. * Any current uncontrolled bacterial, fungal or viral infection
  8. * Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female
  9. * If female, breast feeding

Contacts and Locations

Study Contact

Brandon Triplett, MD
CONTACT
8662785833
referralinfo@stjude.org

Principal Investigator

Brandon Triplett, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Brandon Triplett, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

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 Date2025-12
Study Completion Date2030-12

Study Record Updates

Study Start Date2025-12
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • Hematopoietic Cell Transplant

Additional Relevant MeSH Terms

  • Hematologic Malignancy