Evidence map›Paper›PMID 24573552›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2014

Ultra low-dose IL-2 for GVHD prophylaxis after allogeneic hematopoietic stem cell transplantation mediates expansion of regulatory T cells without diminishing antiviral and antileukemic activity.

Alana A Kennedy-Nasser, Stephanie Ku, Paul Castillo-Caro, Yasmin Hazrat, Meng-Fen Wu, Hao Liu, Jos Melenhorst, A John Barrett, Sawa Ito, Aaron Foster and 9 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06845592 (SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia), which is not on this map. Cited by 133 papers.

0numbers the graph read from it
0cells of the map it votes in
133citing papers in PubMed
13.0field-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.

NCT06845592 narecruitingnot on this mapstarted 2025, after this paper: background citation

SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia

TypeinterventionalSponsorUniversity Of PerugiaRan2025 to 2031Enrolled51ConditionsAcute Myeloid Leukaemia (AML), Acute Lymphoblastic Leukemia ALL, High Risk Leukaemia, Leukaemia RelapseArmstotal marrow/lymphoid irradiation
3 · Its place in the literature

Who cites it

133 citing papers in PubMed, 199 citations in OpenAlex.

  1. Baseline CD4Journal of blood medicine · 2025
    Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Graft-Versus-Host Disease Mouse Models: A Clinical-Translational Perspective.Methods in molecular biology (Clifton, N.J.) · 2025
    Review
  19. Maintenance strategies for relapse prevention and treatment.Hematology. American Society of Hematology. Education Program · 2024
    Review
  20. Review

73 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

19 authors at 4 institutions in 1 country.

Alana A Kennedy-NasserAuthors' Affiliations: Center for Cell and Gene Therapy, Dan L. Duncan Cancer Center, Baylor College of Medicine; The Methodist Hospital, Houston, Texas; and National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.
Stephanie Ku
Paul Castillo-Caro
Yasmin Hazrat
Meng-Fen Wu
Hao Liu
Jos Melenhorst
A John Barrett
Sawa Ito
Aaron Foster
Barbara Savoldo
Eric Yvon
George Carrum
Carlos A Ramos
Robert A Krance
Kathryn Leung
Helen E Heslop
Malcolm K Brenner
Catherine M Bollard
Houston Methodist · USMethodist Hospital · USNational Heart Lung and Blood Institute · USBaylor College of Medicine · US

Funding

Tumor BiologyP30CA125123 · NCI · BAYLOR COLLEGE OF MEDICINE · PI DAVID R ROWLEY · 2007 to 2026
$73.9M
improving outcomes after stem cell transplantationZIAHL006105 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI BARRETT, AUSTIN JOHN · 2011 to 2017
$11.5M
Enhancing Treg Immune Reconstitution After Stem Cell TransplantR21CA149967 · NCI · BAYLOR COLLEGE OF MEDICINE · PI BOLLARD, CATHERINE M. · 2011 to 2012
$638k
NCI NIH HHS 1 R21 CA149967NCI NIH HHS P30 CA125123NCI NIH HHS P30CA125123NCI NIH HHS R21 CA149967
6 · The paper itself

Abstract

purposeGVHD after allogeneic hematopoietic stem cell transplantation (alloSCT) has been associated with low numbers of circulating CD4(+)CD25(+)FoxP3(+) regulatory T cells (Tregs). Because Tregs express high levels of the interleukin (IL)-2 receptor, they may selectively expand in vivo in response to doses of IL-2 insufficient to stimulate T effector T-cell populations, thereby preventing GVHD. EXPERIMENTAL

designWe prospectively evaluated the effects of ultra low-dose (ULD) IL-2 injections on Treg recovery in pediatric patients after alloSCT and compared this recovery with Treg reconstitution post alloSCT in patients without IL-2. Sixteen recipients of related (n = 12) or unrelated (n = 4) donor grafts received ULD IL-2 post hematopoietic stem cell transplantation (HSCT; 100,000-200,000 IU/m(2) ×3 per week), starting <day 30 and continuing for 6 to 12 weeks.

resultsNo grade 3/4 toxicities were associated with ULD IL-2. CD4(+)CD25(+)FoxP3(+) Tregs increased from a mean of 4.8% (range, 0%-11.0%) pre IL-2 to 11.1% (range, 1.2%-31.1%) following therapy, with the greatest change occurring in the recipients of matched related donor (MRD) transplants. No IL-2 patients developed grade 2-4 acute GVHD (aGVHD), compared with 4 of 33 (12%) of the comparator group who did not receive IL-2. IL-2 recipients retained T cells reactive to viral and leukemia antigens, and in the MRD recipients, only 2 of 13 (15%) of the IL-2 patients developed viral infections versus 63% of the comparator group (P = 0.022).

conclusionsHence, ULD IL-2 is well tolerated, expands a Treg population in vivo, and may be associated with a lower incidence of viral infections and GVHD.

Indexed as

AdolescentAntiviral AgentsCell ProliferationChildDose-Response Relationship, DrugFemaleFlow CytometryGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansInterleukin-2LeukemiaLymphocyte CountMaleProspective StudiesT-Lymphocytes, RegulatoryAntiviral AgentsInterleukin-2

Identifiers

PMID24573552
PMCPMC3989436
OpenAlexW2148360092

What OpenQuestion holds

Textmetadata
LicenceTDM
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.