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BackgroundThe number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry.MethodsAn interrupted time-series design was used in the analysis, which was conducted for the period of April 2015 to March 2019. We collected data for trials registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network.ResultsIn total, 35,811 studies were registered in the registry; of these, 16,455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new trials after CTA enforcement decreased significantly by 15.0 trials (95% CI, −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical trials, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors.ConclusionsThe number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety.

Hodgkin lymphoma (HL) is a hematologic malignancy that typically presents with lymphadenopathy. We herein report a patient with HL who presented with an intramuscular mass that required differentiation from an inflammatory lesion. A 65-year-old Japanese woman was referred to our hospital with a chief complaint of chronic and expanding tumor in her left thigh. By surgical resection, she was diagnosed with primary intramuscular, Epstein-Barr virus-positive, mixed-cellularity classic HL. She received combined modality therapy, resulting in a complete response. Primary intramuscular classic HL is extremely rare. It should be listed as a differential diagnosis of intramuscular tumors.

There is a controversy which short term high dose dexamethasone therapy (HDD) or standard dose prednisolone therapy as the initial treatment leads to long term efficacy in idiopathic thrombocytopenic purpura (ITP) patients. We conducted a multicenter, prospective trial to determine the efficacy and safety of short-term HDD in ITP patients aged 18–80 years with platelet counts of

The prevention of invasive fungal infections is important in patients with acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) receiving cytoreductive chemotherapy. However, the role of oral voriconazole (VRCZ) in such patients has not been established. This study aimed to investigate the effectiveness of oral VRCZ compared to that of first-generation azoles prescribed within 7 days after the onset of chemotherapy in adult patients with AML/MDS using the Japanese administrative database.This nationwide retrospective cohort study was conducted using the Diagnosis Procedure Combination/Per-Diem Payment System. The primary outcome was the proportion of patients who switched to intravenous antifungal agents. Analyses using the instrumental variable method were performed to address unmeasured confounding.In total, data on 5517 inpatients from 142 hospitals were analyzed. An oral VRCZ prescription was significantly associated with a reduction in the proportion of patients switching to intravenous antifungal agents compared to first-generation azole prescription (21.0% (95% confidence interval [CI] - 33.4 to - 8.6)). The impact of oral VRCZ in reducing the proportion of patients switching to intravenous antifungal agents was stronger in patients aged 65 years than in those aged ≥ 65 years (- 40.6%, 95% CI - 63.2 to - 17.9; - 21.9%, 95% CI - 35.8 to - 8.1, respectively) and in patients prescribed oral azole within 3 days from the onset of chemotherapy than in those prescribed the same later (- 32.9%, 95% CI - 46.7 to - 19.2; - 9.0%, 95% CI - 33.7 to 15.7, respectively).Oral VRCZ administration may benefit adult patients with AML/MDS undergoing chemotherapy.

We assessed the efficacy and safety of weekly cyclophosphamide-bortezomib-dexamethasone (CBD) induction prior to autologous stem cell transplantation (ASCT) in newly diagnosed Japanese patients with multiple myeloma (MM). This regimen consisted of four 28-day cycles of once-weekly oral cyclophosphamide (300 mg/m2), subcutaneous bortezomib (1.3 mg/m2), and oral dexamethasone (40 mg). Responding patients underwent stem cell collection followed by ASCT. The primary endpoint was the postinduction rate of achieving a near complete response (nCR) or better. Among the 38 enrolled patients, a complete response (CR), an nCR, a very good partial response (VGPR), and a partial response (PR) were achieved in 10.5, 2.6, 23.7, and 36.8% of cases, respectively. A grade 4 hematological adverse event (AE) was observed in 1 patient. Grade 3–4 infection, including febrile neutropenia, was observed in 4 patients (10.5%). Although 2 patients dropped out due to AE, 94.7% of the patients completed the induction phase. However, because of a poor response to induction chemotherapy (

Introduction COVID-19 spread worldwide rapidly since December 12, 2019, affecting more than 180 countries. The rapidly increased number of patients sometimes exceed medical resource capacity. Under the scarce resource situation, clinicians may need to allocate medical resources to selected populations. However, there are no established triage criteria. Therefore, we conducted a scoping review to map the reported triageavailable. We formulated the following primary review question:What kind of criteria and algorithms are available for clinicians to triage patients in the resource scarcity setting during the disease pandemic like COVID-19? Methods and analysis For conducting the scoping review protocol, we will use a scoping review methodology established in the Joanna Briggs Institute manual. We also will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews to assess the results. The concept of our review will be the triage criteria, systems, or algorithms used for the allocation of medical resources to selected populations among patients with the pandemic disease.The context of our review will be the resource scarcity setting during disease pandemic like COVID-19. We will conduct the systematic search on MEDLINE, Embase, and Cochrane controlled register of trials (CENTRAL) and include studies that incorporate critically ill patients due to the pandemic disease itself. We will summarize the studies based on the characteristics and efficiency (if applicable) of triages. Ethics and dissemination Since this is a review of the literature, ethics approval is not mandated. We will publish the results from this review in peer-reviewed journals.

Standard therapy for idiopathic thrombocytopenic purpura (ITP) has not been established. We are conducting a multicenter, prospective trial to determine the efficacy and safety of short-term, high-dose dexamethasone therapy in ITP patients aged 18-80 years with platelet counts of

T-cell prolymphocytic leukemia(T-PLL)is a highly aggressive hematopoietic malignancy with poor prognosis and is extremely rare in Japan. Since T-PLL cells usually express high levels of CD52, the anti-CD52 monoclonal antibody alemtuzumab is expected to exhibit an antitumor effect via its antibody-dependent cell cytotoxicity(ADCC)and complement-dependent cytotoxicity(CDC). However, the therapeutic efficiency of alemtuzumab for T-PLL has not been established in Japan. Furthermore, only a few patients have completed the treatment schedule because of adverse events. Here, we report a 64-yearold woman with multiple comorbidities who was successfully treated with alemtuzumab.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of HBOT for persistent PCS in people with mTBI.

Introduction: Although a previous study with small numbers of patients (Pts) reported comparable efficacy and less toxicity of once-weekly CBD as an induction compared to twice-weekly CBD for newly diagnosed MM (NDMM) Pts (Blood 2010; 115:3416-3417), it has never been verified thereafter. Methods: This multicenter, single-arm, open-label, phase 2 study was conducted at 13 institutions in Japan. Pts aged 15-65 years with NDMM were eligible. Additional inclusion criteria were ECOG PS 0-2 and adequate organ functions. Pts with ≥G2 peripheral neuropathy (PN) were excluded. Pts were enrolled between January 2013 and November 2015. Induction chemotherapy consisted of four 28-day cycles of cyclophosphamide (CPA: 300 mg/m2, PO), bortezomib (1.3 mg/m2, SC), and dexamethasone (40 mg/body, PO) each administered on day 1, 8, 15, and 22. Stem cells were mobilized by administering CPA plus G-CSF. High-dose therapy (HDT) prior to ASCT was performed using melphalan (200 mg/m2). The primary endpoint was the post-induction ≥nCR rate. Observation was stopped on August 31, 2016. Results: A total of 38 Pts with median age of 61 (47-65 years old) were enrolled. ISS stages were I, II, and III in 10, 18, and 10 patients, respectively. Among the 34 chromosomal data-available Pts, del 13 and hypoploidy were observed in 2 and 1, respectively. During the induction, only one patient developed G4 hematological AE. G3 infectious AE was observed in 4 Pts (10.5%). Three Pts (7.9%) developed G4 non-hematological AE. PN was observed in 2 Pts (all VGPR rates improved from 16.7% to 33.3% and from 41.7% to 50.0%, respectively (Fig.1). The median follow-up duration was 578.5 days. PFS at 1, 2, and 3 years was 78.0%, 55.3% and 48.4%, respectively, with a median PFS of 816 days. OS at 1 and 2 years was 97.3% and 82.7%, respectively (Fig.2). The median OS was not reached. The therapeutic efficacy and feasibility of the present study were compared with those in our previous study with the VAD/BD induction regimen, which contained one cycle of VAD followed by 3 cycles of twice-weekly BD (Int J Myeloma 2015; 5:15-22). Although the percentage of Pts discontinuing the induction chemotherapy due to AE was lower for the CBD regimen (5.3% vs 19.5%, p=0.0894), discontinuation due to poor response showed the tendency to be more frequent (15.8% vs 4.9%, p=0.145). There was no significant difference in PFS or OS between these 2 studies. Conclusion: Although once-weekly CBD is a well-tolerated standard induction chemotherapy prior to ASCT for most Japanese patients, its therapeutic power may be too low to achieve a deep response. Disclosures Hori: ONO Pharmaceutical Co., Ltd: Other: Post-marketing surveillance study fees; Sanofi: Other: Post-marketing surveillance study fees; Mundipharma: Other: Post-marketing surveillance study fees.