Research Paper on In patients with hematologic malignancies, a Phase II trial of reduced-intensity conditioning with melphalan based on HLA-haploidentical peripheral blood stem cells was conducted.

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Title: In patients with hematologic malignancies, a Phase II trial of reduced-intensity conditioning with melphalan based on HLA-haploidentical peripheral blood stem cells was conducted.

Abstract: Haplo (posttransplant cyclophosphamide)-based T-replete haploidentical donor transplants have significantly increased donor availability and are being used more frequently. Initially, haplo were carried out with a bone marrow graft and conditioning that was truly nonmyeloablative. Additionally, we have created peripheral blood stem cell (PBSC) grafts and myeloablative conditioning for use with haplo. To control malignancy and reduce graft rejection, some patients who cannot tolerate myeloablative conditioning may still benefit from a more intense preparative regimen. In order to achieve this, we enrolled 25 patients in a prospective phase II trial using the treatment regimen of fludarabine 30 mg/m2/day for 5 days and melphalan 140 mg/m2 on day 1 (flu/mel), followed by the infusion of unaltered PBSC graft from a haploidentical donor. On days 3 and 4, cyclophosphamide 50 mg/kg/day, mycophenolate mofetil on day 35, and tacrolimus on day 180 were used as GVHD preventative measures. The median age was 57. (range from 35 to 68). AML (n = 11), ALL (n = 4), MDS/MPD (n = 6) NHL/CLL (n = 3) and MM (n = 1) were among the transplantation diagnoses. Patients were classified as low (n 1), intermediate (n 13), and high/very high (n 11) using the refined Disease Risk Index (DRI). With a median time to neutrophil and platelet engraftment of 18 days and 36 days, respectively, 22 out of 25 patients engrafted. At day 30, full peripheral blood T-lymphocyte and myeloid donor chimerism was achieved in all engrafting patients. Acute GVHD in grades II–IV and III–IV was observed in 20% (95% CI 8%–37%) and 8% (95% CI 2%–22%) of cases, respectively, over the course of 180 days. The incidence of chronic GVHD over a two-year period was 16% (95% CI 5%-33%) (moderate-severe 12% (95% CI 3%-27%)). The estimated 2-year OS, DFS, NRM, and relapse after a median follow-up of 28.3 months were 56% (95%CI 33-74%), 44% (95%CI 23%-64%), 20% (95% CI 8%-37%), and 36% (95% CI 17%-55%), respectively. 2-year OS was 53% among patients with high/very high risk DRI compared to 69% for low/intermediate DRI. The outcomes were statistically comparable for the 2-year OS at 56% vs. 63% p 0.75 and DFS at 44% vs. 46% p 0.65 when compared with a contemporaneous cohort of patients at our center receiving haploidentical transplant with nonablative fludarabine, Cytoxan, and total body irradiation flu/Cy/TBI regimen.

Paper Quality: SCOPUS / Web of Science Level Research Paper

Subject: Medicine

Sub Category: Hematology

Writer Experience: 20+ Years

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