Evidence map›Paper›PMID 27118571›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2016

Reduced-Intensity Conditioning with Fludarabine, Cyclophosphamide, and High-Dose Rituximab for Allogeneic Hematopoietic Cell Transplantation for Follicular Lymphoma: A Phase Two Multicenter Trial from the Blood and Marrow Transplant Clinical Trials Network.

Ginna G Laport, Juan Wu, Brent Logan, Veronika Bachanova, Chitra Hosing, Timothy Fenske, Walter Longo, Steven M Devine, Auayporn Nademanee, Iris Gersten and 4 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, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00912223 (A Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
6.4field-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.

NCT00912223 phase2completednot on this map

A Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response (BMT CTN #0701)

TypeinterventionalSponsorMedical College of WisconsinRan2009 to 2016Enrolled65ConditionsLymphoma, Non-HodgkinArmsHematopoietic Stem Cell Transplant
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Allogeneic Transplantation after Myeloablative Rituximab/BEAM ± Bortezomib for Patients with Relapsed/Refractory Lymphoid Malignancies: 5-Year Follow-Up Results.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
  4. Updated Results of Rituximab Pre- and Post-BEAM with or withoutClinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Trial
  5. Reduced-Intensity Haploidentical Bone Marrow Transplantation with Post-Transplant Cyclophosphamide for Solid Tumors in Pediatric and Young Adult Patients.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
    Trial
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Updates in chronic graft-versus-host disease.Hematology. American Society of Hematology. Education Program · 2021
    Review
  13. Article
  14. Nine-Year Follow-up of Patients with Relapsed Follicular Lymphoma after Nonmyeloablative Allogeneic Stem Cell Transplant and Autologous Transplant.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 1 country.

Ginna G LaportStanford University Medical Center, Stanford, California.
Juan WuThe EMMES Corporation, Rockville, Maryland.
Brent LoganMedical College of Wisconsin, Milwaukee, Wisconsin.
Veronika BachanovaUniversity of Minnesota, Minneapolis, Minnesota.
Chitra HosingUniversity of Texas/MD Anderson Cancer Center, Houston, Texas.
Timothy FenskeMedical College of Wisconsin, Milwaukee, Wisconsin.
Walter LongoUniversity of Wisconsin, Madison, Wisconsin.
Steven M DevineOhio State/Arthur G. James Cancer Hospital, Columbus, Ohio.
Auayporn NademaneeCity of Hope National Medical Center, Duarte, California.
Iris GerstenThe EMMES Corporation, Rockville, Maryland.
Mary HorowitzMedical College of Wisconsin, Milwaukee, Wisconsin.
Hillard M LazarusUniversity Hospitals of Cleveland/Case Western, Cleveland, Ohio.
Marcie L RichesDivision of Hematology/Oncology, University of North Carolina, Chapel Hill, North Carolina. Electronic address: marcie_riches@med.unc.edu.
Blood and Marrow Transplant Clinical Trials Network
Medical College of Wisconsin · USEmmes (United States) · USCity Of Hope National Medical Center · USStanford University · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe University of Texas MD Anderson Cancer Center · USUniversity Hospitals of Cleveland · USUniversity of Minnesota System · USUniversity of North Carolina at Chapel Hill · USUniversity of Wisconsin–Madison · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
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
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
CWRU Case Comprehensive Cancer Center NCTN Lead Academic Participating SiteU10CA180853 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI GERDS, AARON THOMAS, MACHTAY, MITCHELL · 2014 to 2018
$6.2M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)KL2TR000113 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$5.4M
National Clinical Trials Network Research at the University of WisconsinU10CA180799 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ANDERSON, BETHANY M, KUSHNER, DAVID M · 2014 to 2018
$2.8M
City of Hope Core Clinical Center for the Blood and Marrow Transplant Clinical Trials NetworkUG1HL069278 · NHLBI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI RYOTARO NAKAMURA · 2017 to 2026
$2.2M
Blood and Marrow Transplant Clinical Research NetworkU10HL069278 · NHLBI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI NAKAMURA, RYOTARO · 2011 to 2016
$1.0M
Improving the Outcomes of Stem Cell TransplantationU10HL069334 · NHLBI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI ALOUSI, AMIN MAJID · 2011 to 2016
$974k
Sargrastim and Plerixafor vs. Filgrastim for Allogeneic Stem Cell MobilizationU10HL109137 · NHLBI · WASHINGTON UNIVERSITY · PI WESTERVELT, PETER · 2011 to 2016
$937k
NCATS NIH HHS KL2 TR000113NCATS NIH HHS UL1 TR000114NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180853NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA076518NHLBI NIH HHS U10 HL069278NHLBI NIH HHS U10 HL069290NHLBI NIH HHS U10 HL069294NHLBI NIH HHS U10 HL069334NHLBI NIH HHS U10 HL109137NHLBI NIH HHS UG1 HL069278
6 · The paper itself

Abstract

Allogeneic (allo) hematopoietic cell transplantation (HCT) can induce long-term remissions in chemosensitive relapsed follicular lymphoma (FL). The Blood and Marrow Transplant Clinical Trials Network conducted a multicenter phase 2 trial to examine the efficacy of alloHCT using reduced-intensity conditioning with rituximab (RTX) in multiply relapsed, chemosensitive FL. The primary endpoint was 2-year progression-free survival (PFS). The conditioning regimen consisted of fludarabine, cyclophosphamide, and high-dose RTX (FCR), in which 3 of the 4 doses of RTX were administered at a dose of 1 gm/m(2). Graft-versus-host disease (GVHD) prophylaxis was with tacrolimus and methotrexate. Sixty-five patients were enrolled and 62 were evaluable. Median age was 55 years (range, 29 to 74). This group was heavily pretreated: 77% had received ≥ 3 prior regimens, 32% had received ≥ 5 prior regimens, and 11% had received prior autologous HCT. Donors were HLA-matched siblings (n = 33) or HLA-matched unrelated adults (n = 29). No graft failures occurred. The overall response rate after HCT was 94% with 90% in complete remission (CR), including 24 patients not in CR before alloHCT. With a median follow-up of 47 months (range, 30 to 73), 3-year PFS and overall survival rates were 71% (95% confidence interval, 58% to 81%) and 82% (95% confidence interval, 70% to 90%), respectively. Three-year cumulative incidences of relapse/progression and nonrelapse mortality were 13% and 16%, respectively. Two-year cumulative incidences of grades 2 to 4 and grades 3 or 4 acute GVHD were 27% and 10%, respectively, and extensive chronic GVHD incidence was 55%. Serum RTX concentrations peaked at day +28 and remained detectable as late as 1 year in 59% of patients with available data. In conclusion, alloHCT with FCR conditioning confers high CR rates, a low incidence of relapse/progression, and excellent survival probabilities in heavily pretreated FL patients.

Indexed as

AdultAgedAntineoplastic Agents, ImmunologicalCyclophosphamideGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansLymphoma, FollicularMiddle AgedMyeloablative AgonistsRecurrenceRemission InductionRituximabSalvage TherapySurvival AnalysisTransplantation ConditioningAntineoplastic Agents, ImmunologicalCyclophosphamidefludarabineMyeloablative AgonistsRituximabVidarabineAllogeneic transplantationClinical trialFollicular lymphomaReduced intensity

Identifiers

PMID27118571
PMCPMC4949103
OpenAlexW2337724293

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.