Evidence map›Paper›PMID 26053664›Full record

Trial reportThe Journal of clinical investigation2015

Outcomes of acute leukemia patients transplanted with naive T cell-depleted stem cell grafts.

Marie Bleakley, Shelly Heimfeld, Keith R Loeb, Lori A Jones, Colette Chaney, Stuart Seropian, Ted A Gooley, Franziska Sommermeyer, Stanley R Riddell, Warren D Shlomchik

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The Journal of clinical investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 173 papers.

0numbers the graph read from it
0cells of the map it votes in
173citing papers in PubMed
20.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03810196 narecruitingnot on this mapstarted 2019, after this paper: background citation

CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ/CD19 Depleted Hematopoietic Stem Cell Transplant

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2019 to 2028Enrolled50ConditionsAcute Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic LeukemiaArmsCliniMACS Cell Processing System for TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback
NCT06839456 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Phase 1/2 Study: CD45RA Depleted Peripheral Stem Cell Addback to Prevent Viral and Fungal Infections Following Alternative Donor TCRab/CD19 Depleted Hematopoietic Stem Cell Transplant

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2025 to 2032Enrolled100ConditionsLeukemia, High Risk Acute Lymphoblastic Leukemia, High Risk Acute Myeloid Leukemia, Relapse LeukemiaArmsPhase 1 Dose Level 1, Phase 1 Dose Level 2, Phase 1 Dose Level 3, Phase 2 Maximum Tolerated Dose determined in Phase 1, Phase 2 Established Dose from prior study, NCT03810196
3 · Its place in the literature

Who cites it

173 citing papers in PubMed, 266 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Naive T-Cell Depletion to Prevent Chronic Graft-Versus-Host Disease.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Impact of T Cell Dose on Outcome of T Cell-Replete HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
  8. Distinct Biomarker Profiles in Ex Vivo T Cell Depletion Graft Manipulation Strategies: CD34Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Anti-thymocyte globulin-resistant CD4Blood science (Baltimore, Md.) · 2026
    Article

113 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Marie Bleakley
Shelly Heimfeld
Keith R Loeb
Lori A Jones
Colette Chaney
Stuart Seropian
Ted A Gooley
Franziska Sommermeyer
Stanley R Riddell
Warren D Shlomchik
Institute for Advanced Study · DESeattle Cancer Care Alliance · USUniversity of Pittsburgh · USUniversity of Washington · US

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Eric Collisson · 1985 to 2026
$296.4M
VIRUS-MEDIATED MYELOSUPPRESSIONP01CA018029 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI STEPHANIE J LEE · 1985 to 2026
$128.4M
Easy-to-read Informed Consent for HCT Clinical TrialsU10HL069294 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI HOROWITZ, MARY MARESCA · 2011 to 2016
$43.8M
CORE--VECTOR PRODUCTIONP30DK056465 · NIDDK · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BERNSTEIN, IRWIN D · 1999 to 2014
$14.9M
Stem Cell and Transplantation BiologyU54DK106829 · NIDDK · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DEREK L STIREWALT · 2015 to 2026
$9.1M
Targeted therapy of B cell malignances with CAR-T cells of defined compositionR01CA136551 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI JENSEN, MICHAEL C, RIDDELL, STANLEY R. · 2009 to 2018
$5.5M
Naive T cell depletion to prevent graft-versus-host diseaseR01HL121568 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BLEAKLEY, MARIE, RIDDELL, STANLEY R. · 2014 to 2018
$2.7M
Allogeneic stem cell transplant with grafts depleted of naive T cells for leukemiK23CA154532 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BLEAKLEY, MARIE · 2011 to 2015
$850k
NCI NIH HHS K23 CA154532NCI NIH HHS P01 CA018029NCI NIH HHS P30 CA015704NCI NIH HHS R01 CA136551NHLBI NIH HHS R01 HL121568NHLBI NIH HHS U10 HL069294NIDDK NIH HHS P30 DK056465NIDDK NIH HHS U54 DK106829Wellcome Trust
6 · The paper itself

Abstract

backgroundGraft-versus-host disease (GVHD) is a major cause of morbidity and mortality following allogeneic hematopoietic stem cell transplantation (HCT). In mice, naive T cells (TN) cause more severe GVHD than memory T cells (TM). We hypothesized that selective depletion of TN from human allogeneic peripheral blood stem cell (PBSC) grafts would reduce GVHD and provide sufficient numbers of hematopoietic stem cells and TM to permit hematopoietic engraftment and the transfer of pathogen-specific T cells from donor to recipient, respectively.

methodsIn a single-arm clinical trial, we transplanted 35 patients with high-risk leukemia with TN-depleted PBSC grafts following conditioning with total body irradiation, thiotepa, and fludarabine. GVHD prophylactic management was with tacrolimus immunosuppression alone. Subjects received CD34-selected PBSCs and a defined dose of TM purged of CD45RA+ TN. Primary and secondary objectives included engraftment, acute and chronic GVHD, and immune reconstitution.

resultsAll recipients of TN-depleted PBSCs engrafted. The incidence of acute GVHD was not reduced; however, GVHD in these patients was universally corticosteroid responsive. Chronic GVHD was remarkably infrequent (9%; median follow-up 932 days) compared with historical rates of approximately 50% with T cell-replete grafts. TM in the graft resulted in rapid T cell recovery and transfer of protective virus-specific immunity. Excessive rates of infection or relapse did not occur and overall survival was 78% at 2 years.

conclusionDepletion of TN from stem cell allografts reduces the incidence of chronic GVHD, while preserving the transfer of functional T cell memory.

trial registrationClinicalTrials.gov (NCT 00914940).

Indexed as

Acute DiseaseAdolescentAdrenal Cortex HormonesAdultAnimalsChronic DiseaseDisease-Free SurvivalFemaleGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHistocompatibility TestingHumansKaplan-Meier EstimateLeukemiaLymphocyte DepletionMaleAdrenal Cortex Hormones

Identifiers

PMID26053664
PMCPMC4563691
OpenAlexW1603504083

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.