Evidence map›Paper›PMID 21320619›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2011

Low risk of chronic graft-versus-host disease and relapse associated with T cell-depleted peripheral blood stem cell transplantation for acute myelogenous leukemia in first remission: results of the blood and marrow transplant clinical trials network protocol 0303.

Steven M Devine, Shelly Carter, Robert J Soiffer, Marcelo C Pasquini, Parameswaran N Hari, Anthony Stein, Hillard M Lazarus, Charles Linker, Edward A Stadtmauer, Edwin P Alyea and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00201240 (A Phase 2 Single Arm Trial of HLA-Matched Transplants, CD34+ Enriched, T-Cell Depleted Peripheral Blood Stem Cells Isolated by CliniMACS System in the Treatment of Patients With AML in 1st or 2nd Morphologic Complete Remission), which is not on this map. Cited by 89 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT00201240 phase2completednot on this map

A Phase 2 Single Arm Trial of HLA-Matched Transplants, CD34+ Enriched, T-Cell Depleted Peripheral Blood Stem Cells Isolated by CliniMACS System in the Treatment of Patients With AML in 1st or 2nd Morphologic Complete Remission (BMTCTN0303)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2005 to 2013Enrolled47ConditionsLeukemia, Myelocytic, AcuteArmsCD34+ selection with CliniMACS device
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 1 synthesis or guideline pooled it, 150 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Trial
  4. Standard Antithymocyte Globulin Dosing Results in Poorer Outcomes in Overexposed Patients after Ex Vivo CD34Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Donor selection, graft engineering, and dosing oh my!Hematology. American Society of Hematology. Education Program · 2025
    Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 1 country.

Steven M DevineMedicine Department of Ohio State University, Columbus, Ohio, USA. steven.devine@osumc.edu
Shelly Carter
Robert J Soiffer
Marcelo C Pasquini
Parameswaran N Hari
Anthony Stein
Hillard M Lazarus
Charles Linker
Edward A Stadtmauer
Edwin P Alyea
Carolyn A Keever-Taylor
Richard J O'Reilly
Medical College of Wisconsin · USDana-Farber Cancer Institute · USCity Of Hope National Medical Center · USEmmes (United States) · USMemorial Sloan Kettering Cancer Center · USThe Ohio State University · USUniversity Hospitals Case Medical Center · USUniversity of California, San Francisco · USUniversity of Pennsylvania · US

Funding

Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
Easy-to-read Informed Consent for HCT Clinical TrialsU10HL069294 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI HOROWITZ, MARY MARESCA · 2011 to 2016
$43.8M
BMT CTN Core - Dana-Farber Cancer Institute and MGH ConsortiumUG1HL069249 · NHLBI · DANA-FARBER CANCER INST · PI Mahasweta Gooptu · 2017 to 2026
$2.2M
Phase III Trial of UCB +/- MSCs in Hematologic CancersU01HL069348 · NHLBI · CASE WESTERN RESERVE UNIVERSITY · PI LAZARUS, HILLARD M · 2001 to 2010
$2.1M
BMT CTN Core- University of Pennsylvania Abramson Cancer CenterUG1HL069286 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI Edward A Stadtmauer · 2017 to 2026
$2.0M
A Randomized Trial of Tac/MTX/bortezomib vs Tac/MTXplacebo in Allogeneic HSCTU10HL069249 · NHLBI · DANA-FARBER CANCER INST · PI ANTIN, JOSEPH H · 2011 to 2016
$1.1M
Bone Marrow Transplant Clinical NetworkU10HL069286 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI STADTMAUER, EDWARD A · 2011 to 2016
$986k
University of Michigan Core Clinical Center for BMT Research NetworkU10HL069330 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI YANIK, GREGORY A · 2011 to 2016
$959k
Case BMT CTN: Antibacterial Prophylaxis in Post-Engraftment Allogeneic HCTU10HL069348 · NHLBI · CASE WESTERN RESERVE UNIVERSITY · PI DE LIMA, MARCOS · 2011 to 2016
$902k
NCI NIH HHS U24 CA076518NHLBI NIH HHS U01 HL069348NHLBI NIH HHS U10 HL069249NHLBI NIH HHS U10 HL069286NHLBI NIH HHS U10 HL069294NHLBI NIH HHS U10 HL069330NHLBI NIH HHS U10 HL069348NHLBI NIH HHS UG1 HL069286
6 · The paper itself

Abstract

Graft-versus-host disease (GVHD) is most effectively prevented by ex vivo T cell depletion (TCD) of the allograft, but its role in the treatment of patients undergoing allogeneic hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML) in complete remission (CR) remains unclear. We performed a phase 2 single-arm multicenter study to evaluate the role of TCD in AML patients in CR1 or CR2 up to age 65 years. The primary objective was to achieve a disease-free survival (DFS) rate of >75% at 6 months posttransplantation. A total of 44 patients with AML in CR1 (n = 37) or CR2 (n = 7) with a median age of 48.5 years (range, 21-59 years) received myeloablative chemotherapy and fractionated total body irradiation (1375 cGy) followed by immunomagnetically selected CD34-enriched, T cell‒depleted allografts from HLA-identical siblings. No pharmacologic GVHD prophylaxis was given. All patients engrafted. The incidence of acute GVHD grade II-IV was 22.7%, and the incidence of extensive chronic GVHD was 6.8% at 24 months. The relapse rate for patients in CR1 was 17.4% at 36 months. With a median follow-up of 34 months, DFS for all patients was 82% at 6 months, and DFS for patients in CR1 was 72.8% at 12 months and 58% at 36 months. HCT after myeloablative chemoradiotherapy can be performed in a multicenter setting using a uniform method of TCD, resulting in a low risk of extensive chronic GVHD and relapse for patients with AML in CR1.

Indexed as

AdultAntigens, CD34Chronic DiseaseGraft vs Host DiseaseHumansLeukemia, Myeloid, AcuteLymphocyte DepletionMiddle AgedMyeloablative AgonistsPeripheral Blood Stem Cell TransplantationRecurrenceRiskTransplantation, HomologousTreatment OutcomeWhole-Body IrradiationYoung AdultAntigens, CD34Myeloablative Agonists

Identifiers

PMID21320619
PMCPMC3150599
OpenAlexW1970070684

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.