Evidence map›Paper›PMID 26378033›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2016

A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation.

Sally Arai, Joseph Pidala, Iskra Pusic, Xiaoyu Chai, Samantha Jaglowski, Nandita Khera, Jeanne Palmer, George L Chen, Madan H Jagasia, Sebastian A Mayer and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01309997 (A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell Transplantation), which is not on this map. Cited by 50 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% 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.

NCT01309997 phase2completednot on this map

A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell Transplantation

TypeinterventionalSponsorLee, StephanieRan2011 to 2015Enrolled72ConditionsGraft Versus Host Disease, Systemic SclerodermaArmsimatinib mesylate, rituximab
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Trial
  4. A Multicenter Phase II Trial of Ruxolitinib for Treatment of Corticosteroid Refractory Sclerotic Chronic Graft-Versus-Host Disease.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Anti-Platelet-Derived Growth Factor Receptor Alpha Chain Antibodies Predict for Response to Nilotinib in Steroid-Refractory or -Dependent Chronic Graft-Versus-Host Disease.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
  11. Trial
  12. Observational
  13. Article
  14. Review
  15. Article
  16. Modern-Era Challenges in the Clinical Management of Graft-Versus-Host Disease.Advances in experimental medicine and biology · 2025
    Review
  17. Review
  18. Review
  19. Article
  20. Review
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

21 authors at 1 institution in 1 country.

Sally AraiDepartment of Medicine/Division of Blood and Marrow Transplant, Stanford University School of Medicine, Stanford, California.
Joseph PidalaBlood and Marrow Transplantation, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
Iskra PusicDivision of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, St. Louis, Missouri.
Xiaoyu ChaiClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Samantha JaglowskiDivision of Hematology, Internal Medicine, Ohio State University, Columbus, Ohio.
Nandita KheraDivision of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona.
Jeanne PalmerDivision of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona.
George L ChenDepartment of Medicine/Division of Blood and Marrow Transplant, Stanford University School of Medicine, Stanford, California.
Madan H JagasiaDepartment of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
Sebastian A MayerMayer Weill Cornell Medical College, New York, New York.
William A WoodDepartment of Hematology/Oncology, University of North Carolina, Chapel Hill, North Carolina.
Michael GreenDivision of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke Cancer Institute, Duke University, Durham, North Carolina.
Teresa S HyunClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Yoshihiro InamotoClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Barry E StorerClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
David B MiklosDepartment of Medicine/Division of Blood and Marrow Transplant, Stanford University School of Medicine, Stanford, California.
Howard M ShulmanClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Paul J MartinClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Stefanie SarantopoulosDivision of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke Cancer Institute, Duke University, Durham, North Carolina.
Stephanie J LeeClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Mary E D FlowersClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. mflowers@fhcrc.org.
Fred Hutch Cancer Center · US

Funding

Training and Career Development CoreU54CA163438 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEE, STEPHANIE J · 2011 to 2014
$3.7M
NCI NIH HHS U54 CA163438
6 · The paper itself

Abstract

purposeCutaneous sclerosis occurs in 20% of patients with chronic graft-versus-host disease (GVHD) and can compromise mobility and quality of life. EXPERIMENTAL

designWe conducted a prospective, multicenter, randomized, two-arm phase II crossover trial of imatinib (200 mg daily) or rituximab (375 mg/m(2) i.v. weekly × 4 doses, repeatable after 3 months) for treatment of cutaneous sclerosis diagnosed within 18 months (NCT01309997). The primary endpoint was significant clinical response (SCR) at 6 months, defined as quantitative improvement in skin sclerosis or joint range of motion. Treatment success was defined as SCR at 6 months without crossover, recurrent malignancy or death. Secondary endpoints included changes of B-cell profiles in blood (BAFF levels and cellular subsets), patient-reported outcomes, and histopathology between responders and nonresponders with each therapy.

resultsSCR was observed in 9 of 35 [26%; 95% confidence interval (CI); 13%-43%] participants randomized to imatinib and 10 of 37 (27%; 95% CI, 14%-44%) randomized to rituximab. Six (17%; 95% CI, 7%-34%) patients in the imatinib arm and 5 (14%; 95% CI, 5%-29%) in the rituximab arm had treatment success. Higher percentages of activated B cells (CD27(+)) were seen at enrollment in rituximab-treated patients who had treatment success (P = 0.01), but not in imatinib-treated patients.

conclusionsThese results support the need for more effective therapies for cutaneous sclerosis and suggest that activated B cells define a subgroup of patients with cutaneous sclerosis who are more likely to respond to rituximab.

Indexed as

AdultAgedB-LymphocytesCross-Over StudiesFemaleGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansImatinib MesylateMaleMiddle AgedProspective StudiesRituximabSclerosisSkin DiseasesTumor Necrosis Factor Receptor Superfamily, Member 7Imatinib MesylateRituximabTumor Necrosis Factor Receptor Superfamily, Member 7

Identifiers

PMID26378033
PMCPMC4715914
OpenAlexW2216107281

What OpenQuestion holds

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LicenceTDM
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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.