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

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Date
2016-01-15
Authors
Arai, Sally
Pidala, Joseph
Pusic, Iskra
Chai, Xiaoyu
Jaglowski, Samantha
Khera, Nandita
Palmer, Jeanne
Chen, George L
Jagasia, Madan H
Mayer, Sebastian A
Wood, William A
Green, Michael
Hyun, Teresa S
Inamoto, Yoshihiro
Storer, Barry E
Miklos, David B
Shulman, Howard M
Martin, Paul J
Sarantopoulos, Stefanie
Lee, Stephanie J
Flowers, Mary ED
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Abstract
PURPOSE: Cutaneous sclerosis occurs in 20% of patients with chronic graft-versus-host disease (GVHD) and can compromise mobility and quality of life. EXPERIMENTAL DESIGN: We 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. RESULTS: SCR 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. CONCLUSIONS: These 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.
Type
Journal article
Subject
Adult
Aged
Antigens, CD27
B-Lymphocytes
Cross-Over Studies
Female
Graft vs Host Disease
Hematopoietic Stem Cell Transplantation
Humans
Imatinib Mesylate
Male
Middle Aged
Prospective Studies
Rituximab
Sclerosis
Skin Diseases
Young Adult
Permalink
https://hdl.handle.net/10161/12562
Published Version (Please cite this version)
10.1158/1078-0432.CCR-15-1443
Publication Info
Arai, Sally; Pidala, Joseph; Pusic, Iskra; Chai, Xiaoyu; Jaglowski, Samantha; Khera, Nandita; ... Flowers, Mary ED (2016). A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation. Clin Cancer Res, 22(2). pp. 319-327. 10.1158/1078-0432.CCR-15-1443. Retrieved from https://hdl.handle.net/10161/12562.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Sarantopoulos

Stefanie Sarantopoulos

Professor of Medicine
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