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

Publication ,  Journal Article
Arai, S; Pidala, J; Pusic, I; Chai, X; Jaglowski, S; Khera, N; Palmer, J; Chen, GL; Jagasia, MH; Mayer, SA; Wood, WA; Green, M; Hyun, TS ...
Published in: Clin Cancer Res
January 15, 2016

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.

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Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

January 15, 2016

Volume

22

Issue

2

Start / End Page

319 / 327

Location

United States

Related Subject Headings

  • Young Adult
  • Tumor Necrosis Factor Receptor Superfamily, Member 7
  • Skin Diseases
  • Sclerosis
  • Rituximab
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Imatinib Mesylate
 

Citation

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Arai, S., Pidala, J., Pusic, I., Chai, X., Jaglowski, S., Khera, N., … Flowers, M. E. D. (2016). A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation. Clin Cancer Res, 22(2), 319–327. https://doi.org/10.1158/1078-0432.CCR-15-1443
Arai, Sally, Joseph Pidala, Iskra Pusic, Xiaoyu Chai, Samantha Jaglowski, Nandita Khera, Jeanne Palmer, et al. “A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation.Clin Cancer Res 22, no. 2 (January 15, 2016): 319–27. https://doi.org/10.1158/1078-0432.CCR-15-1443.
Arai S, Pidala J, Pusic I, Chai X, Jaglowski S, Khera N, et al. A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation. Clin Cancer Res. 2016 Jan 15;22(2):319–27.
Arai, Sally, et al. “A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation.Clin Cancer Res, vol. 22, no. 2, Jan. 2016, pp. 319–27. Pubmed, doi:10.1158/1078-0432.CCR-15-1443.
Arai S, Pidala J, Pusic I, Chai X, Jaglowski S, Khera N, Palmer J, Chen GL, Jagasia MH, Mayer SA, Wood WA, Green M, Hyun TS, Inamoto Y, Storer BE, Miklos DB, Shulman HM, Martin PJ, Sarantopoulos S, Lee SJ, Flowers MED. A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation. Clin Cancer Res. 2016 Jan 15;22(2):319–327.

Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

January 15, 2016

Volume

22

Issue

2

Start / End Page

319 / 327

Location

United States

Related Subject Headings

  • Young Adult
  • Tumor Necrosis Factor Receptor Superfamily, Member 7
  • Skin Diseases
  • Sclerosis
  • Rituximab
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Imatinib Mesylate