RECRUITING

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

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Conditions

Allogeneic Hematopoietic Cell Transplantation (HCT)Advanced Hematologic MalignanciesAcute LeukemiaChronic Myelogenous LeukemiaMyelodysplastic SyndromesMyeloproliferative DisordersReduced intensity conditioning (RIC)GVHD

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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

Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.

Official Title

Phase 1 Trial for Patients With Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells

Quick Facts

Study Start:2021-09-07
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05088356

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Acute myeloid, lymphoid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or beyond first complete remission (CR1) without the presence of minimal residual disease
  2. * Acute myeloid, leukemia, or mixed phenotype leukemia that is either:
  3. * Not in morphologic CR with bone marrow infiltration by leukemic blasts of ≤10%, or
  4. * In morphologic CR with evidence of minimal residual disease positivity by either multiparametric flow cytometric analysis or by a nucleic acid-based technique
  5. * Primary refractory acute myeloid, lymphoid, or mixed phenotype leukemia
  6. * Chronic myelogenous leukemia (accelerated, blast or second chronic phase)
  7. * Myelodysplastic syndromes
  8. * Myeloproliferative syndromes b. Match to the patient as follows: a. For Arm A1 (CLOSED):
  9. * Availability of a 8/8 or 7/8 HLA-matched donor (related or unrelated) defined by Class I (HLA-A, -B, -C) serologic typing (or higher resolution) and Class II (HLA-DRB1) molecular typing.
  10. * If the donor is a 7/8 HLA-match, the mismatch must be a permissive allelic mismatch as assessed by an independent HLA and transplantation expert. b. For Arm A1 and Arm A3:
  11. * Availability of a 8/8 HLA-matched donor (related or unrelated) defined by Class I (HLA-A, -B, -C) serologic typing (or higher resolution) and Class II (HLA-DRB1) molecular typing.
  12. * Availability of a haploidentical donor who is a ≥ 4/8 but \<7/8 match at HLA-A, -B, -C, and -DRB1 (typed using DNA-based high-resolution methods), with at most one mismatch per locus d. For Arm C1 (CLOSED) and C2:
  13. * Availability of a 8/8 HLA matched donor (related or unrelated) defined by Class I (HLA-A, B, C) serologic typing (or higher resolution) and Class II (HLA DRB1) molecular typing.
  14. 1. Age ≥ 18 and ≤ 75 years of age
  15. 2. Karnofsky performance status of ≥ 70% defined by institutional standards
  16. 3. Seronegative for HIV-1 RNA PCR; HIV 1 and HIV 2 ab (antibody); HTLV-1 and HTLV-2 ab; PCR+ or sAg (surface antigen) hepatitis B ; or PCR or sAg negative for hepatitis C; negative for the Treponema palladum antibody Syphillis screen; and negative for HIV-1 and hepatitis C by nucleic acid testing (NAT) within 30 days of apheresis collection.
  17. 4. In the case that T palladum antibody tests are positive, donors must:
  18. 1. Arm A1(CLOSED):
  19. 2. Arm A2 and Arm A3:
  20. 3. Arm B (CLOSED):
  21. * Must be a haploidentical donor who is ≥ 4/8 but \< 7/8 match at HLA-A, -B, -C, and -DRB1, with at most one mismatch per locus.
  22. 4. Arm C1 (CLOSED) and Arm C2:
  23. * Must be a related or unrelated 7/8 HLA matched to recipient at HLA A, B, C, DRB1 or -DQB1
  24. * The donor is a first-degree or second-degree blood relative of the recipient, or
  25. * Documented urgent medical need (DUMN), meaning no comparable human cell product is available and the recipient is likely to suffer death or serious morbidity without the human cell product, as attested by the Investigator or sub-investigator
  1. 1. Seropositive for any of the following:
  2. 2. Patients deemed candidates for fully myeloablative preparative conditioning regimens
  3. * A positive crossmatch of any titer; or
  4. * The presence of anti-donor HLA antibody to any HLA locus n. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment o. Concurrent malignancies or active disease within 1 year, except nonmelanomatous skin cancers that have been curatively resected
  5. 1. Evidence of active infection
  6. 2. Seropositive for HIV-1 or-2, HTLV-1 or -2
  7. 3. Medical, physical, or psychological reason that would place the donor at increased risk for complications from growth factor or leukapheresis
  8. 4. Lactating female

Contacts and Locations

Study Contact

Lindsay Danley
CONTACT
650-736-0304
lindsmd@stanford.edu

Principal Investigator

Everett Meyer, MD,PhD
PRINCIPAL_INVESTIGATOR
Stanford Universiy

Study Locations (Sites)

Stanford University
Stanford, California, 94304
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Everett Meyer, MD,PhD, PRINCIPAL_INVESTIGATOR, Stanford Universiy

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 Date2021-09-07
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-09-07
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Reduced intensity conditioning (RIC)
  • GVHD

Additional Relevant MeSH Terms

  • Allogeneic Hematopoietic Cell Transplantation (HCT)
  • Advanced Hematologic Malignancies
  • Acute Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders