Evidence map›Paper›PMID 34855460›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Randomized Phase III BMT CTN Trial of Calcineurin Inhibitor-Free Chronic Graft-Versus-Host Disease Interventions in Myeloablative Hematopoietic Cell Transplantation for Hematologic Malignancies.

Leo Luznik, Marcelo C Pasquini, Brent Logan, Robert J Soiffer, Juan Wu, Steven M Devine, Nancy Geller, Sergio Giralt, Helen E Heslop, Mary M Horowitz and 14 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06799195 (A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies), which is not on this map. Cited by 111 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 3 pooled it
15.2field-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.

NCT06799195 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies: the PROMISE Trial

TypeinterventionalSponsorUniversity of NebraskaRan2025 to 2031Enrolled126ConditionsHematological Malignancies, Graft-versus-Host Disease (GVHD)ArmsAttenuated-dose Cyclophosphamide, High-dose Cyclophosphamide, Sirolimus, Mycophenolate Mofetil (MMF)
3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 3 syntheses or guidelines pooled it, 160 citations in OpenAlex.

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  17. 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
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51 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

24 authors at 15 institutions in 2 countries.

Leo LuznikJohns Hopkins Medical Center, Baltimore, MD.
Marcelo C PasquiniMedical College of Wisconsin, Milwaukee, WI.ORCID 0000-0003-1579-2293
Brent LoganMedical College of Wisconsin, Milwaukee, WI.ORCID 0000-0002-4473-4044
Robert J SoifferDana Farber Cancer Institute, Boston, MA.
Juan WuEmmes Company, Rockville, MD.
Steven M DevineNational Marrow Donor Program/Be the Match, Minneapolis, MN.ORCID 0000-0001-7731-759X
Nancy GellerNational Heart, Lung and Blood Institute, Rockville, MD.ORCID 0000-0003-0500-7386
Sergio GiraltMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-1944-5053
Helen E HeslopBaylor College of Medicine, Houston, TX.ORCID 0000-0001-7049-7698
Mary M HorowitzMedical College of Wisconsin, Milwaukee, WI.ORCID 0000-0002-9502-785X
Richard J JonesJohns Hopkins Medical Center, Baltimore, MD.
Mark R LitzowMayo Clinic, Rochester, MN.ORCID 0000-0002-9816-6302
Adam MendizabalEmmes Company, Rockville, MD.
Lori MufflyStanford University, Palo Alto, CA.ORCID 0000-0002-9887-6136
Eneida R NemecekOregon Health & Science University, Portland, OR.
Lynn O'DonnellOhio State University, Columbus, OH.
Richard J O'ReillyMemorial Sloan Kettering Cancer Center, New York, NY.
Raquel PalenciaDKMS, Dresden, Germany.
Johannes ScheteligDKMS, Dresden, Germany.ORCID 0000-0002-2780-2981
Leyla ShuneUniversity of Kansas Health Systems, Kansas City, KS.
Scott R SolomonBMT Georgia at Northside Hospital, Atlanta, GA.ORCID 0000-0003-2061-8126
Sumithira VasuOhio State University, Columbus, OH.
Vincent T HoDana Farber Cancer Institute, Boston, MA.
Miguel-Angel PeralesMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5910-4571
Medical College of Wisconsin · USMemorial Sloan Kettering Cancer Center · USDana-Farber Cancer Institute · USDeutsche Knochenmarkspenderdatei · DEEmmes (United States) · USJohns Hopkins University · USThe Ohio State University · USBaylor College of Medicine · USMayo Clinic in Arizona · USNational Heart Lung and Blood Institute · USNational Marrow Donor Program · USNorthside Hospital · USOregon Health & Science University · USPalo Alto University · USUniversity of Kansas · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Blood and Marrow Transplant Clinical Trials Network DCC- The Medical College of Wisconsin, Inc.U24HL138660 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI Steven M. DeVine, Mehdi Hussain Hamadani · 2017 to 2026
$71.4M
Easy-to-read Informed Consent for HCT Clinical TrialsU10HL069294 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI HOROWITZ, MARY MARESCA · 2011 to 2016
$43.8M
MSKCC BMT CTN RenewalUG1HL069315 · NHLBI · SLOAN-KETTERING INST CAN RESEARCH · PI MIGUEL-ANGEL PERALES · 2017 to 2026
$2.2M
BMT CTN Core - Dana-Farber Cancer Institute and MGH ConsortiumUG1HL069249 · NHLBI · DANA-FARBER CANCER INST · PI Mahasweta Gooptu · 2017 to 2026
$2.2M
Targeting HIV and EBV Antigens in Patients with HIV LymphomaUG1HL108945 · NHLBI · BAYLOR COLLEGE OF MEDICINE · PI Catherine M. Bollard, HELEN E HESLOP · 2017 to 2026
$2.1M
Core Clinical Centers for the Blood and Marrow Transplant Clinical Trials Network (UG1)UG1HL108987 · NHLBI · H. LEE MOFFITT CANCER CTR & RES INST · PI Joseph A Pidala · 2017 to 2026
$2.1M
The Ohio State University Blood and Marrow Transplant Research ConsortiumUG1HL109322 · NHLBI · OHIO STATE UNIVERSITY · PI Sumithira Vasu · 2017 to 2026
$2.0M
Mount Sinai Core Clinical Consortium for the BMT Clinical Trials NetworkUG1HL138645 · NHLBI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI JOHN LEVINE · 2017 to 2026
$1.9M
Translational Research in Blood &Marrow TransplantationU01HL069310 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI JONES, RICHARD J · 2001 to 2010
$1.7M
BMT Core - Stanford UniversityUG1HL069291 · NHLBI · STANFORD UNIVERSITY · PI Lori Muffly · 2017 to 2026
$1.7M
Translational Research in Blood and Marrow TransplantationUG1HL069310 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI RICHARD J JONES · 2017 to 2026
$1.6M
NCI NIH HHS P30 CA008748NHLBI NIH HHS U01 HL069310NHLBI NIH HHS U10 HL069294NHLBI NIH HHS U24 HL138660NHLBI NIH HHS UG1 HL069249NHLBI NIH HHS UG1 HL069291NHLBI NIH HHS UG1 HL069310NHLBI NIH HHS UG1 HL069315NHLBI NIH HHS UG1 HL108945NHLBI NIH HHS UG1 HL108987NHLBI NIH HHS UG1 HL109322NHLBI NIH HHS UG1 HL138645
6 · The paper itself

Abstract

purposeCalcineurin inhibitors (CNI) are standard components of graft-versus-host disease (GVHD) prophylaxis after hematopoietic cell transplantation (HCT). Prior data suggested that CNI-free approaches using donor T-cell depletion, either by ex vivo CD34 selection or in vivo post-transplant cyclophosphamide (PTCy) as a single agent, are associated with lower rates of chronic GVHD (cGVHD).

methodsThis multicenter phase III trial randomly assigned patients with acute leukemia or myelodysplasia and an HLA-matched donor to receive CD34-selected peripheral blood stem cell, PTCy after a bone marrow (BM) graft, or tacrolimus and methotrexate after BM graft (control). The primary end point was cGVHD (moderate or severe) or relapse-free survival (CRFS).

resultsAmong 346 patients enrolled, 327 received HCT, 300 per protocol. Intent-to-treat rates of 2-year CRFS were 50.6% for CD34 selection (hazard ratio [HR] compared with control, 0.80; 95% CI, 0.56 to 1.15;

conclusionCNI-free interventions as performed herein did not result in superior CRFS compared with tacrolimus and methotrexate with BM. Lower rates of moderate and severe cGVHD did not translate into improved survival.

Indexed as

Hematopoietic Stem Cell TransplantationTransplantation ConditioningAdolescentAdultAgedCalcineurin InhibitorsChronic DiseaseCyclophosphamideDisease-Free SurvivalDrug Therapy, CombinationFemaleGermanyGraft vs Host DiseaseHematologic NeoplasmsHumansImmunosuppressive AgentsCalcineurin InhibitorsCyclophosphamideImmunosuppressive AgentsMethotrexateMyeloablative AgonistsTacrolimus

Identifiers

PMID34855460
PMCPMC8797487
OpenAlexW3215586931

What OpenQuestion holds

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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.