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Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation.

Publication ,  Journal Article
Martin, PJ; Nelson, BJ; Appelbaum, FR; Anasetti, C; Deeg, HJ; Hansen, JA; McDonald, GB; Nash, RA; Sullivan, KM; Witherspoon, RP; Scannon, PJ ...
Published in: Blood
August 1, 1996

Acute graft-versus-host disease (GVHD) is most often treated with high dose glucocorticoids, but less than half of patients have durable overall improvement. Previous phase I and phase II studies suggested that treatment with a CD5-specific immunotoxin (XomaZyme-CD5 Plus) could ameliorate symptoms of GVHD. In a randomized, double-blind trial, we compared XomaZyme-CD5 Plus and glucocorticoids versus placebo and glucocorticoids as initial therapy for 243 patients who developed acute GVHD after allogeneic marrow transplantation. The study drug (XomaZyme. CD5-Plus or an identical appearing placebo) was administered at a dose of 0.1 mg/kg body weight on each of 14 consecutive days. All patients were treated concomitantly with a standard regimen of methylprednisolone. At the time of entry on study, 94% of patients had a rash, 56% had hyperbilirubinemia, 61% had diarrhea, and 84% had nausea and vomiting. At 3, 4, and 5 weeks after starting treatment, symptom severity was less in the CD5 group than in the placebo group. At 4 weeks, 40% of patients assigned to the CD5 group had complete response compared with 25% of those assigned to the control group (P = .019). At 6 weeks, 44% of patients assigned to the CD5 group had complete response as compared with 38% in the placebo group (P = .36). Clinical extensive chronic GVHD developed in 65% of patients in the CD5 group compared with 72% in the control group (P = .35). Survival at 1 year after treatment was 49% in the CD5 group and 45% in the control group (P = .68). Side effects required close monitoring and appropriate adjustment of treatment. The combined administration of a CD5-specific immunotoxin and glucocorticoids controls GVHD manifestations more effectively than treatment with glucocorticoids alone during the first 5 weeks after starting treatment. Use of this immunotoxin does not result in any long-term clinical benefit for patients with acute GVHD.

Duke Scholars

Published In

Blood

ISSN

0006-4971

Publication Date

August 1, 1996

Volume

88

Issue

3

Start / End Page

824 / 830

Location

United States

Related Subject Headings

  • Treatment Outcome
  • T-Lymphocytes, Cytotoxic
  • Ricin
  • Middle Aged
  • Methylprednisolone
  • Male
  • Lymphocyte Depletion
  • Kidney Diseases
  • Infant
  • Immunotoxins
 

Citation

APA
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MLA
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Martin, P. J., Nelson, B. J., Appelbaum, F. R., Anasetti, C., Deeg, H. J., Hansen, J. A., … Storb, R. (1996). Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation. Blood, 88(3), 824–830.
Martin, P. J., B. J. Nelson, F. R. Appelbaum, C. Anasetti, H. J. Deeg, J. A. Hansen, G. B. McDonald, et al. “Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation.Blood 88, no. 3 (August 1, 1996): 824–30.
Martin PJ, Nelson BJ, Appelbaum FR, Anasetti C, Deeg HJ, Hansen JA, et al. Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation. Blood. 1996 Aug 1;88(3):824–30.
Martin PJ, Nelson BJ, Appelbaum FR, Anasetti C, Deeg HJ, Hansen JA, McDonald GB, Nash RA, Sullivan KM, Witherspoon RP, Scannon PJ, Friedmann N, Storb R. Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation. Blood. 1996 Aug 1;88(3):824–830.

Published In

Blood

ISSN

0006-4971

Publication Date

August 1, 1996

Volume

88

Issue

3

Start / End Page

824 / 830

Location

United States

Related Subject Headings

  • Treatment Outcome
  • T-Lymphocytes, Cytotoxic
  • Ricin
  • Middle Aged
  • Methylprednisolone
  • Male
  • Lymphocyte Depletion
  • Kidney Diseases
  • Infant
  • Immunotoxins