A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation.
dc.contributor.author | Arai, Sally | |
dc.contributor.author | Pidala, Joseph | |
dc.contributor.author | Pusic, Iskra | |
dc.contributor.author | Chai, Xiaoyu | |
dc.contributor.author | Jaglowski, Samantha | |
dc.contributor.author | Khera, Nandita | |
dc.contributor.author | Palmer, Jeanne | |
dc.contributor.author | Chen, George L | |
dc.contributor.author | Jagasia, Madan H | |
dc.contributor.author | Mayer, Sebastian A | |
dc.contributor.author | Wood, William A | |
dc.contributor.author | Green, Michael | |
dc.contributor.author | Hyun, Teresa S | |
dc.contributor.author | Inamoto, Yoshihiro | |
dc.contributor.author | Storer, Barry E | |
dc.contributor.author | Miklos, David B | |
dc.contributor.author | Shulman, Howard M | |
dc.contributor.author | Martin, Paul J | |
dc.contributor.author | Sarantopoulos, Stefanie | |
dc.contributor.author | Lee, Stephanie J | |
dc.contributor.author | Flowers, Mary ED | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2016-08-01T17:02:19Z | |
dc.date.issued | 2016-01-15 | |
dc.description.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. | |
dc.identifier | ||
dc.identifier | 1078-0432.CCR-15-1443 | |
dc.identifier.issn | 1078-0432 | |
dc.identifier.uri | ||
dc.language | eng | |
dc.publisher | American Association for Cancer Research (AACR) | |
dc.relation.ispartof | Clin Cancer Res | |
dc.relation.isversionof | 10.1158/1078-0432.CCR-15-1443 | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Antigens, CD27 | |
dc.subject | B-Lymphocytes | |
dc.subject | Cross-Over Studies | |
dc.subject | Female | |
dc.subject | Graft vs Host Disease | |
dc.subject | Hematopoietic Stem Cell Transplantation | |
dc.subject | Humans | |
dc.subject | Imatinib Mesylate | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Prospective Studies | |
dc.subject | Rituximab | |
dc.subject | Sclerosis | |
dc.subject | Skin Diseases | |
dc.subject | Young Adult | |
dc.title | A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation. | |
dc.type | Journal article | |
pubs.author-url | ||
pubs.begin-page | 319 | |
pubs.end-page | 327 | |
pubs.issue | 2 | |
pubs.organisational-group | Basic Science Departments | |
pubs.organisational-group | Clinical Science Departments | |
pubs.organisational-group | Duke | |
pubs.organisational-group | Duke Cancer Institute | |
pubs.organisational-group | Immunology | |
pubs.organisational-group | Institutes and Centers | |
pubs.organisational-group | Medicine | |
pubs.organisational-group | Medicine, Cellular Therapy | |
pubs.organisational-group | School of Medicine | |
pubs.publication-status | Published | |
pubs.volume | 22 |
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