PMID- 14641143 OWN - NLM STAT- MEDLINE DCOM- 20040909 LR - 20190922 IS - 0141-9854 (Print) IS - 0141-9854 (Linking) VI - 25 IP - 6 DP - 2003 Dec TI - Nonmyeloablative stem cell transplantation with fludarabine and cyclophosphamide for patients with hematologic malignancies. PG - 383-91 AB - We conducted a multi-center phase I/II trial of nonmyeloablative stem cell transplantation for patients with hematologic malignancies. The aim of this trial was to assess the safety and feasibility of this treatment modality for older or younger patients with significant organ dysfunction, who could not be treated with conventional high dose chemoradiotherapy. Twelve patients were treated with a conditioning regimen consisting of fludarabine and cyclophosphamide, followed by peripheral blood stem cell transplantation from human leukocyte antigen (HLA) identical siblings. Nonhematologic toxicities were mild. Median time to absolute neutrophils above 0.5 x 10(9)/l, 1.0 x 10(9)/l and platelets above 50 x 10(9)/l were 8, 10 and 12 days, respectively. Donor dominant hematopoiesis was achieved in all patients, with or without donor leukocyte infusion. The cumulative incidence of acute and chronic graft-versus-host disease (GVHD) was 75 and 56%, respectively. Only one patient experienced early death within 100 days, caused by acute GVHD complicated by fungal infection. All patients except one achieved complete remission. With a median follow-up of 330 days, expected progression-free survival is 75%. Overall survival is 76%. Our study confirms that nonmyeloablative stem cell transplantation with cyclophosphamide and fludarabine conditioning is a safe and promising treatment for elderly patients with hematologic malignancies. A further study in large-scale setting is warranted. FAU - Nakajima, H AU - Nakajima H AD - Division of Hematology/Medical Oncology, Tokai University School of Medicine, Boseidai, Isehara, Japan. FAU - Oki, M AU - Oki M FAU - Kishi, K AU - Kishi K FAU - Ueyama, Jun-Ichi AU - Ueyama J FAU - Miyakoshi, S AU - Miyakoshi S FAU - Hatsumi, N AU - Hatsumi N FAU - Sakura, T AU - Sakura T FAU - Miyawaki, S AU - Miyawaki S FAU - Yokota, A AU - Yokota A FAU - Fujisawa, S AU - Fujisawa S FAU - Mori, S AU - Mori S FAU - Tanaka, Y AU - Tanaka Y FAU - Sakamaki, H AU - Sakamaki H CN - Kanto Study Group for Cell Therapy LA - eng PT - Clinical Trial PT - Clinical Trial, Phase I PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PL - England TA - Clin Lab Haematol JT - Clinical and laboratory haematology JID - 7907061 RN - 0 (Benzamides) RN - 0 (Piperazines) RN - 0 (Pyrimidines) RN - 8A1O1M485B (Imatinib Mesylate) RN - 8N3DW7272P (Cyclophosphamide) RN - FA2DM6879K (Vidarabine) RN - P2K93U8740 (fludarabine) SB - IM MH - Age Factors MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Benzamides MH - Combined Modality Therapy MH - Cyclophosphamide/administration & dosage MH - Disease-Free Survival MH - Feasibility Studies MH - Female MH - Graft Survival MH - Graft vs Host Disease/epidemiology/etiology MH - Hematologic Neoplasms/drug therapy/mortality/*therapy MH - Humans MH - Imatinib Mesylate MH - Incidence MH - Leukocyte Transfusion MH - Life Tables MH - Male MH - Middle Aged MH - Neoplasm, Residual MH - *Peripheral Blood Stem Cell Transplantation/adverse effects MH - Piperazines/administration & dosage MH - Pyrimidines/administration & dosage MH - Remission Induction MH - Survival Analysis MH - Transplantation Chimera MH - Transplantation Conditioning MH - Treatment Outcome MH - Vidarabine/administration & dosage/*analogs & derivatives EDAT- 2003/12/03 05:00 MHDA- 2004/09/10 05:00 CRDT- 2003/12/03 05:00 PHST- 2003/12/03 05:00 [pubmed] PHST- 2004/09/10 05:00 [medline] PHST- 2003/12/03 05:00 [entrez] AID - 550 [pii] AID - 10.1046/j.0141-9854.2003.00550.x [doi] PST - ppublish SO - Clin Lab Haematol. 2003 Dec;25(6):383-91. doi: 10.1046/j.0141-9854.2003.00550.x.