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- W1976211833 abstract "We prospectively evaluated survival after NST dUCBT for poor risk acute leukemia or lymphoma (excluding mantle cell) in patients without a suitably matched related donor. Eligible were patients aged ≤ 70 years with adequate organ function (ejection fraction > 35%; lung function > 50% predicted; total bilirubin ≤ 2.5 mg/dl, liver enzymes < 5 × upper limit of normal; CrCl > 40 mL/min/1.73m2), performance score (PS) ≥ 60, and > 3 months after prior autologous transplant. The preparative regimen consisted of fludarabine 40 mg/m2 IV days –6 to -2, cyclophosphamide 50 mg/kg IV day -6, total body irradiation 200 cGy day –1 and immunosuppression with a calcineurin inhibitor and mycophenolate mofetil. G-CSF started at day +1. All patients received dUCB grafts HLA-matched 4-6/6 (A and B at antigen level, DRB1 allele level) to the patient and to each other. Fifty-four patients were enrolled from 16 centers; 4 of 54 patients were excluded due to progressive disease prior to dUCBT (n = 3) and 1 withdrew consent. The median age was 58 yrs (range, 16-69) and weight, 79kg (range, 46-119). Thirty-six patients had acute leukemia (64% were in CR1) and 14 patients had lymphoma. Six patients (12%) had a prior autologous transplant. The median infused combined nucleated cell dose was 4.2 × 107/kg (2.3-13.6). Fifty-three percent of the units were 4/6 and 39% were 5/6 HLA-matched to the recipient; 66% of patients received at least one 4/6 HLA-matched unit. Most patients (80%) had PS 90-100. The median follow-up of survivors was 364 days (range, 154-381). The 6-month probability of overall survival was 72% (95%CI, 56-83%) and progression-free survival 63% (95%CI, 48-76%). The cumulative incidence of treatment-related mortality at day-180 was 20% (95%CI, 8-31%) and relapse/progression, 14% (95%CI, 4-24%). Eighteen patients died and relapse/progression was the most common cause (N = 9). The cumulative incidence of grade II-IV acute GVHD at day 56 is 36% (95%CI, 22-50%) and grade III-IV 10% (95%CI, 2-19%) and chronic GVHD at 180 days was 13% (5%CI, 3-24%). The cumulative incidence of neutrophil recovery at day 56 was 94.0% (95%CI, 87-100.0%) at a median time of 17 days (range, 6-45). Three patients had primary and 1 secondary graft failure. These data demonstrate that NST dUCBT is safe, reproduced results from single centers in the multicenter setting, and establishes the framework for randomized trials to study alternative donor NST transplantation for hematologic malignancies." @default.
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- W1976211833 date "2011-02-01" @default.
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- W1976211833 title "Phase II Trial of Non-Myeloablative Conditioning (NST) Double Umbilical Cord Blood Transplantation (DUCBT) From Unrelated Donors in Patients With Hematologic Malignancies: Results of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Protocol 0604" @default.
- W1976211833 doi "https://doi.org/10.1016/j.bbmt.2010.12.006" @default.
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