Evidence map›Paper›PMID 22546497›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2012

Fludarabine-based conditioning for marrow transplantation from unrelated donors in severe aplastic anemia: early results of a cyclophosphamide dose deescalation study show life-threatening adverse events at predefined cyclophosphamide dose levels.

Jakub Tolar, H Joachim Deeg, Sally Arai, Mitchell Horwitz, Joseph H Antin, John M McCarty, Roberta H Adams, Marian Ewell, Eric S Leifer, Iris D Gersten and 8 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IClinical 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, 2012. 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 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.5field-weighted citation impact, top 7% 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.

NCT00326417 phase1 / phase2completednot on this map

Fludarabine-based Conditioning for Allogeneic Marrow Transplantation From HLA-compatible Unrelated Donors in Severe Aplastic Anemia (BMT CTN #0301)

TypeinterventionalSponsorMedical College of WisconsinRan2006 to 2016Enrolled97ConditionsAnemia, AplasticArmsFludarabine, Cyclophosphamide 150mg, Cyclophosphamide 100mg, Cyclophosphamide 50mg
NCT01759732 phase2unknown statusnot on this map

Haploidentical Stem Cell Transplantation With Fixed Dose of T Cells After in Vitro T Cell Depletion Using CD3 Monoclonal Antibody for Children With Acquired Severe Aplastic Anemia

TypeinterventionalSponsorAsan Medical CenterRan2012 to 2015Enrolled10ConditionsAcquired Aplastic AnemiaArmsFludarabine, Cyclophosphamide, anti-thymocyte globulin, filgrastim, Total body irradiation
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. CD3Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Article
  14. Review
  15. Diagnosis and Treatment of Aplastic Anemia.Current treatment options in oncology · 2017
    Review
  16. Article
  17. Article
  18. Transplantation for bone marrow failure: current issues.Hematology. American Society of Hematology. Education Program · 2016
    Review
  19. The Blood and Marrow Transplant Clinical Trials Network: An Effective Infrastructure for Addressing Important Issues in Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 15 institutions in 2 countries.

Jakub TolarDivision of Blood and Marrow Transplantation, Department of Pediatrics, University of Minnesota Medical School, 420 Delaware Street SE, Minneapolis,MN 55455, USA. tolar003@umn.edu
H Joachim Deeg
Sally Arai
Mitchell Horwitz
Joseph H Antin
John M McCarty
Roberta H Adams
Marian Ewell
Eric S Leifer
Iris D Gersten
Shelly L Carter
Mary M Horowitz
Ryotaro Nakamura
Michael A Pulsipher
Nancy L Difronzo
Dennis L Confer
Mary Eapen
Paolo Anderlini
Emmes (United States) · USMedical College of Wisconsin · USCancer Research Center · USCity of Hope · USDana-Farber Cancer Institute · USDuke University · USNational Heart Lung and Blood Institute · USNational Institutes of Health · USNational Marrow Donor Program · USPhoenix Children's Hospital · USStanford Medicine · USThe University of Texas MD Anderson Cancer Center · USUniversity of Minnesota · USUniversity of Utah · USVirginia Commonwealth University · US

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
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
BLOOD AND MARROW TRANSPLANT CLINICAL RESEARCH NETWORKU01HL069246 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI APPELBAUM, FREDERICK · 2002 to 2010
$2.1M
Blood and Marrow Transplant Clinical Trials NetworkUG1HL069274 · NHLBI · DUKE UNIVERSITY · PI MITCHELL E HORWITZ · 2017 to 2026
$2.0M
Blood & Marrow Clinical Trials Network - Hutchinson Center Core Clinical SitU10HL069246 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI APPELBAUM, FREDERICK · 2011 to 2016
$1.1M
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
Improving the Outcomes of Stem Cell TransplantationU10HL069334 · NHLBI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI ALOUSI, AMIN MAJID · 2011 to 2016
$974k
Blood and Marrow Transplant Clinical Trials NetworkU10HL069274 · NHLBI · DUKE UNIVERSITY · PI KURTZBERG, JOANNE · 2011 to 2016
$968k
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
Enhancing the Safety of Allogeneic TransplantationU10HL069290 · NHLBI · UNIVERSITY OF MINNESOTA · PI WEISDORF, DANIEL J · 2011 to 2016
$931k
NCI NIH HHS P30 CA015704NCI NIH HHS U24 CA076518NHLBI NIH HHS EQ1 U10HL069294NHLBI NIH HHS U01 HL069246NHLBI NIH HHS U10 HL069246NHLBI NIH HHS U10 HL069249NHLBI NIH HHS U10 HL069254NHLBI NIH HHS U10 HL069274NHLBI NIH HHS U10 HL069290NHLBI NIH HHS U10 HL069294NHLBI NIH HHS U10 HL069330NHLBI NIH HHS U10 HL069334NHLBI NIH HHS UG1 HL069274
6 · The paper itself

Abstract

Excessive adverse events were encountered in a Phase I/II study of cyclophosphamide (CY) dose deescalation in a fludarabine-based conditioning regimen for bone marrow transplantation from unrelated donors in patients with severe aplastic anemia. All patients received fixed doses of antithymocyte globulin, fludarabine, and low-dose total body irradiation. The starting CY dose was 150 mg/kg, with deescalation to 100 mg/kg, 50 mg/kg, or 0 mg/kg. CY dose level 0 mg/kg was closed due to graft failure in 3 of 3 patients. CY dose level 150 mg/kg was closed due to excessive organ toxicity (n = 6) or viral pneumonia (n = 1), resulting in the death of 7 of 14 patients. CY dose levels 50 and 100 mg/kg remain open. Thus, CY at doses of 150 mg/kg in combination with total body irradiation (2 Gy), fludarabine (120 mg/m(2)), and antithymocyte globulin was associated with excessive organ toxicity.

Indexed as

Bone Marrow TransplantationTransplantation ConditioningAcute DiseaseAdolescentAdultAgedAnemia, AplasticAntilymphocyte SerumAntineoplastic AgentsChildCyclophosphamideDrug Administration ScheduleDrug Dosage CalculationsFemaleHumansMaleAntilymphocyte SerumAntineoplastic AgentsCyclophosphamidefludarabineVidarabine

Identifiers

PMID22546497
PMCPMC3677744
OpenAlexW2025183952

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.