Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
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Biol. Blood Marrow Transplant. · Jan 2001
Practice Guideline GuidelineGuidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients: focus on community respiratory virus infections.
Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant (HSCT) recipients, cosponsored by the Centers for Disease Control and Prevention, the Infectious Diseases Society of America, and the American Society for Blood and Marrow Transplantation, were issued in October 2000. The guidelines recommend that to minimize transmission of community respiratory virus (CRV) infection, health care workers and visitors with symptoms of upper respiratory tract infection be restricted from having contact with HSCT recipients and candidates undergoing conditioning therapy. To screen HSCT recipients for CRVs, active clinical surveillance for CRV disease should be conducted on all hospitalized HSCT recipients and candidates undergoing conditioning therapy, including daily monitoring for signs and symptoms of CRV infections. ⋯ If test results are positive, the patient should be treated early and aggressively. Early preemptive therapy with such treatments as aerosolized ribavirin has been proposed, but limited data preclude a recommendation as to the optimal strategy. Lifelong seasonal influenza vaccination is recommended for all HSCT recipients.
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Biol. Blood Marrow Transplant. · Jan 2001
ReviewMethodologic guidelines for the design of high-dose chemotherapy regimens.
The objective of this report is to review the research methods that have been used in the design, analysis, and reporting of Phase I dose-escalation studies of high-dose chemotherapy (HDCT) with bone marrow or stem cell support and to propose new guidelines for such studies that incorporate emerging principles of pharmacology, toxicity assessment, statistical design, and long-term follow-up. ⋯ Phase I clinical trials in the HDCT setting have been designed, analyzed, and reported using heterogeneous methods that limited their application to Phase II and II investigations. Moreover, correlative pharmacologic analyses have not been routinely undertaken during this critical Phase I stage. We propose guidelines for the design of new Phase I studies of HDCT based on 4 essential elements: (1) rational preclinical and clinical pharmacologic foundation for the regimen and for the agent selected for dose escalation; (2) incorporation of analytical pharmacology in the design and analysis of the regimen under investigation; (3) clear, prospective definitions of the dose- or exposure-limiting toxicities that can be distinguished from modality-dependent toxicities; selection of an appropriate toxicity grading scale, including an assessment of cumulative, delayed, and long-term effects of HDCT, particularly when designing tandem or repetitive cycle regimens; and (4) statistical input into the design, execution, analysis, interpretation, and reporting of these studies.
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Biol. Blood Marrow Transplant. · Jan 2001
ReviewDiagnosis and epidemiology of community-acquired respiratory virus infections in the immunocompromised host.
Infections due to community-acquired respiratory viruses are important causes of morbidity and mortality among immunocompromised patients. Respiratory syncytial virus, influenza viruses, and parainfluenza viruses are the most frequent causes of serious lower respiratory tract infections in this patient population. Early diagnosis, often possible with the use of rapid detection assays, is essential for optimal management and prevention of the spread of these serious infections to other vulnerable patients.
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Biol. Blood Marrow Transplant. · Jan 2001
Clinical TrialAllogeneic cell therapy for patients who relapse after autologous stem cell transplantation.
Allogeneic donor leukocytes can be used after nonmyeloablative conditioning to exploit their graft-versus-tumor (GVT) activity in the setting of reduced conditioning-regimen toxicity. This approach may be particularly useful for patients who relapse after autologous stem cell transplantation (SCT). However, GVT activity, toxicity, and ability to establish mixed chimerism may differ in patients who were heavily pretreated prior to SCT compared with patients treated earlier in the course of their disease. ⋯ However, these data show that ACT with either DLI or G-CSF-stimulated blood cells results in direct GVT activity in some patients with Hodgkin's disease, myeloma, and non-Hodgkin's lymphoma, even after relapse from autologous SCT. Most patients developed donor chimerism with minimal conditioning. Alternative prophylactic regimens that control GVHD while maintaining GVT are needed to improve outcomes in these heavily pretreated patients.
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Biol. Blood Marrow Transplant. · Jan 2001
Randomized Controlled Trial Clinical TrialRandomized open-label trial of dolasetron for the control of nausea and vomiting associated with high-dose chemotherapy with hematopoietic stem cell transplantation.
A prospective open-label trial was performed to compare the efficacy of dolasetron with that of ondansetron or granisetron (standard therapy) for prevention of nausea and vomiting associated with high-dose chemotherapy with or without total body irradiation followed by hematopoietic stem cell transplantation (HSCT). In a university teaching hospital setting, 62 patients were randomized to receive either dolasetron 100 mg daily or standard doses of ondansetron or granisetron. In addition to objective data such as number of episodes of emesis and quantity of rescue antiemetics required, 100 mm visual analogue scales were used to rate nausea, appetite, and changes in taste. ⋯ Patients in the standard therapy group used fewer rescue antiemetics and also rated more favorably on selected questions of the visual analogue scale. No differences in safety parameters or adverse effects were reported. At doses prescribed in this study, dolasetron was less effective than granisetron or ondansetron in preventing nausea and vomiting associated with high-dose chemotherapy/total body irradiation followed by HSCT.