A phase I-II study of high-dose thiotepa, busulfan and cyclophosphamide as a preparative regimen for allogeneic marrow transplantation

Bone Marrow Transplant. 1994 Sep;14(3):449-53.

Abstract

Thirty adults with hematologic malignancies at high-risk for relapse were treated on a phase I-II study of high-dose thiotepa, busulfan (BU) and cyclophosphamide (CY) as the preparative regimen for allogeneic marrow transplantation. Cyclosporine and methylprednisolone or anti-CD5 ricin A chain immunoconjugate were used as graft-versus-host disease prophylaxis. Filgrastim was given from day 1 to enhance engraftment. Median follow-up time is 16 months (range 9-29 months). Grades III-IV regimen-related toxicity occurred in 5 (26%) of 19 patients treated with thiotepa 250 mg/m2 x 3, BU 1 mg/kg x 12 and CY 60 mg/kg x 2 and this was considered the maximal tolerated dose-schedule. Stomatitis and hepatoxicity were dose-limiting. All patients engrafted and had complete donor chimerism. The actuarial rate of acute graft-versus-host disease was 71% (95% CI 62-80%). The relapse rate at 1 year was 38% (95% CI 25-50%) and the actuarial survival at 1 year was 30% (95% CI 22-38%). The combination of thiotepa, BU and CY is tolerable as a preparative regimen for allogeneic marrow transplantation.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bone Marrow Transplantation*
  • Busulfan / administration & dosage*
  • Busulfan / adverse effects
  • Combined Modality Therapy
  • Cyclophosphamide / administration & dosage*
  • Cyclophosphamide / adverse effects
  • Female
  • Follow-Up Studies
  • Graft vs Host Disease / etiology
  • Hematologic Diseases / drug therapy
  • Hematologic Diseases / mortality
  • Hematologic Diseases / therapy*
  • Humans
  • Leukemia / therapy
  • Lymphoma / therapy
  • Male
  • Middle Aged
  • Myelodysplastic Syndromes / therapy
  • Survival Rate
  • Thiotepa / administration & dosage*
  • Thiotepa / adverse effects
  • Transplantation, Homologous

Substances

  • Cyclophosphamide
  • Thiotepa
  • Busulfan