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Prospective phase II trial to evaluate the complications and kinetics of chimerism induction following allogeneic hematopoietic stem cell transplantation with fludarabine and busulfan.
Am J Hematol. 2007 Oct; 82(10):873-80.AJ

Abstract

This prospective trial assessed the safety and efficacy of allogeneic hematopoietic stem cell transplantation from a HLA-matched donor with a reduced-intensity regimen (RIST) consisting of iv fludarabine 30 mg/m(2) for 6 days and oral busulfan 4 mg/kg/day for 2 days in patients older than 50 years with hematological malignancies. Cyclosporine alone or cyclosporine with short-term methotrexate was randomized for graft-versus-host disease prophylaxis. After 30 patients had been enrolled, an interim analysis was performed, and this report focuses on a precise evaluation of the toxicity profile and chimerism kinetics. Sustained engraftment in all patients, no severe regimen-related toxicity (RRT) within 20 days, and no transplant-related mortality through Day 100 were observed. T-cell (CD3+) full-donor (over 90%) chimerism was observed in 22 of the 30 patients, while the remaining eight had mixed-donor chimerism over 77% on Day 90. Thereafter, five subsequently converted to full-donor chimerism without donor lymphocyte infusion by day 120 (n = 4) or Day 180 (n = 1). Two showed persistent mixed chimerism without relapse through Day 180. Grade III-IV acute graft-versus-host disease and extensive chronic graft-versus-host disease occurred in 10% and 73%, respectively. With a median follow-up of 1.5 years, overall survival and disease-free survival at 1 year was 83% and 62%, respectively. Seven patients hematologically relapsed overall, and five of them had myelodysplastic syndrome with poor prognostic factors. In older patients, RIST with fludarabine and busulfan was associated with acceptable toxicities and a satisfactory antileukemia effect, regardless of the early chimerism status.

Authors+Show Affiliations

Department of Hematology and Oncology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. akiko_saito@dfci.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17570513

Citation

Saito, Akiko M., et al. "Prospective Phase II Trial to Evaluate the Complications and Kinetics of Chimerism Induction Following Allogeneic Hematopoietic Stem Cell Transplantation With Fludarabine and Busulfan." American Journal of Hematology, vol. 82, no. 10, 2007, pp. 873-80.
Saito AM, Kami M, Mori S, et al. Prospective phase II trial to evaluate the complications and kinetics of chimerism induction following allogeneic hematopoietic stem cell transplantation with fludarabine and busulfan. Am J Hematol. 2007;82(10):873-80.
Saito, A. M., Kami, M., Mori, S., Kanda, Y., Suzuki, R., Mineishi, S., Takami, A., Taniguchi, S., Takemoto, Y., Hara, M., Yamaguchi, M., Hino, M., Yoshida, T., Kim, S. W., Hori, A., Ohashi, Y., & Takaue, Y. (2007). Prospective phase II trial to evaluate the complications and kinetics of chimerism induction following allogeneic hematopoietic stem cell transplantation with fludarabine and busulfan. American Journal of Hematology, 82(10), 873-80.
Saito AM, et al. Prospective Phase II Trial to Evaluate the Complications and Kinetics of Chimerism Induction Following Allogeneic Hematopoietic Stem Cell Transplantation With Fludarabine and Busulfan. Am J Hematol. 2007;82(10):873-80. PubMed PMID: 17570513.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective phase II trial to evaluate the complications and kinetics of chimerism induction following allogeneic hematopoietic stem cell transplantation with fludarabine and busulfan. AU - Saito,Akiko M, AU - Kami,Masahiro, AU - Mori,Shin-Ichiro, AU - Kanda,Yoshinobu, AU - Suzuki,Ritsuro, AU - Mineishi,Shin, AU - Takami,Akiyoshi, AU - Taniguchi,Shuichi, AU - Takemoto,Yoshinobu, AU - Hara,Masamichi, AU - Yamaguchi,Masaki, AU - Hino,Masayuki, AU - Yoshida,Takashi, AU - Kim,Sung-Won, AU - Hori,Akiko, AU - Ohashi,Yasuo, AU - Takaue,Yoichi, PY - 2007/6/16/pubmed PY - 2007/11/9/medline PY - 2007/6/16/entrez SP - 873 EP - 80 JF - American journal of hematology JO - Am J Hematol VL - 82 IS - 10 N2 - This prospective trial assessed the safety and efficacy of allogeneic hematopoietic stem cell transplantation from a HLA-matched donor with a reduced-intensity regimen (RIST) consisting of iv fludarabine 30 mg/m(2) for 6 days and oral busulfan 4 mg/kg/day for 2 days in patients older than 50 years with hematological malignancies. Cyclosporine alone or cyclosporine with short-term methotrexate was randomized for graft-versus-host disease prophylaxis. After 30 patients had been enrolled, an interim analysis was performed, and this report focuses on a precise evaluation of the toxicity profile and chimerism kinetics. Sustained engraftment in all patients, no severe regimen-related toxicity (RRT) within 20 days, and no transplant-related mortality through Day 100 were observed. T-cell (CD3+) full-donor (over 90%) chimerism was observed in 22 of the 30 patients, while the remaining eight had mixed-donor chimerism over 77% on Day 90. Thereafter, five subsequently converted to full-donor chimerism without donor lymphocyte infusion by day 120 (n = 4) or Day 180 (n = 1). Two showed persistent mixed chimerism without relapse through Day 180. Grade III-IV acute graft-versus-host disease and extensive chronic graft-versus-host disease occurred in 10% and 73%, respectively. With a median follow-up of 1.5 years, overall survival and disease-free survival at 1 year was 83% and 62%, respectively. Seven patients hematologically relapsed overall, and five of them had myelodysplastic syndrome with poor prognostic factors. In older patients, RIST with fludarabine and busulfan was associated with acceptable toxicities and a satisfactory antileukemia effect, regardless of the early chimerism status. SN - 0361-8609 UR - https://www.unboundmedicine.com/medline/citation/17570513/Prospective_phase_II_trial_to_evaluate_the_complications_and_kinetics_of_chimerism_induction_following_allogeneic_hematopoietic_stem_cell_transplantation_with_fludarabine_and_busulfan_ L2 - https://doi.org/10.1002/ajh.20977 DB - PRIME DP - Unbound Medicine ER -