scholarly journals Easy-to-Read Informed Consent Forms for Hematopoietic Cell Transplantation Clinical Trials

2012 ◽  
Vol 18 (2) ◽  
pp. 183-189 ◽  
Author(s):  
Ellen M. Denzen ◽  
Martha E. Burton Santibáñez ◽  
Heather Moore ◽  
Amy Foley ◽  
Iris D. Gersten ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Consent Forms

scholarly journals Real-world outcomes of adult B-cell acute lymphocytic leukemia patients treated with blinatumomab

2020 ◽  
Vol 4 (10) ◽  
pp. 2308-2316 ◽  
Author(s):  
Talha Badar ◽  
Aniko Szabo ◽  
Anjali Advani ◽  
Martha Wadleigh ◽  
Shukaib Arslan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Complete Remission ◽  
B Cell ◽  
Cell Transplantation ◽  
Real World ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Count Recovery

Abstract The availability and use of blinatumomab symbolizes a paradigm shift in the management of B-cell acute lymphoblastic leukemia (ALL). We conducted a retrospective multicenter cohort analysis of 239 ALL patients (227 relapsed refractory [RR], n = 227; minimal residual disease [MRD], n = 12) who received blinatumomab outside of clinical trials to evaluate safety and efficacy in the “real-world” setting. The median age of patients at blinatumomab initiation was 48 years (range, 18-85). Sixty-one (26%) patients had ≥3 prior therapies and 46 (19%) had allogeneic hematopoietic cell transplantation before blinatumomab. The response rate (complete remission/complete remission with incomplete count recovery) in patients with RR disease was 65% (47% MRD−). Among 12 patients who received blinatumomab for MRD, 9 (75%) patients achieved MRD negativity. In patients with RR disease, median relapse-free survival and overall survival (OS) after blinatumomab was 32 months and 12.7 months, respectively. Among patients who received blinatumomab for MRD, median relapse-free survival was not reached (54% MRD− at 2 years) and OS was 34.7 months. Grade ≥3 cytokine release syndrome, neurotoxicity, and hepatotoxicity were observed in 3%, 7%, and 10% of patients, respectively. Among patients who achieved complete remission/complete remission with incomplete count recovery, consolidation therapy with allogeneic hematopoietic cell transplantation retained favorable prognostic significance for OS (hazard ratio, 0.54; 95% confidence interval, 0.30-0.97; P = .04). In this largest “real-world” experience published to date, blinatumomab demonstrated responses comparable to those reported in clinical trials. The optimal sequencing of newer therapies in ALL requires further study.

scholarly journals Microbiome Anomalies in Allogeneic Hematopoietic Cell Transplantation

2020 ◽  
Vol 71 (1) ◽  
pp. 137-148 ◽  
Author(s):  
Zaker I. Schwabkey ◽  
Robert R. Jenq
Keyword(s):  
Clinical Trials ◽  
Cell Transplantation ◽  
Human Body ◽  
Hematopoietic Cell Transplantation ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Hematopoietic Cell ◽  
Allogeneic Hematopoietic Cell Transplantation ◽  
Proper Selection ◽  
Targeted Interventions

The microbiome is an integrated part of the human body that can modulate a variety of disease processes and affect prognosis, treatment response, complications, and outcomes. The importance of allogeneic hematopoietic cell transplantation in cancer treatment has resulted in extensive investigations on the interaction between the microbiome and this treatment modality. These investigations are beginning to lead to clinical trials of microbiome-targeted interventions. Here we review some of these discoveries and describe strategies being investigated to manipulate the microbiome for favorable outcomes, such as the proper selection and timing of antibiotics, type of diet and route of administration, probiotics, prebiotics, and fecal microbiota transplantation.

scholarly journals Hematopoietic Cell Transplantation for Myelodysplastic Syndromes

2016 ◽  
Vol 12 (9) ◽  
pp. 786-792 ◽  
Author(s):  
Vijaya Raj Bhatt ◽  
David P. Steensma
Keyword(s):  
Clinical Trials ◽  
Cell Transplantation ◽  
Myelodysplastic Syndromes ◽  
Lower Risk ◽  
Hematopoietic Cell Transplantation ◽  
Disease Risk ◽  
Hematopoietic Cell ◽  
Comorbidity Index ◽  
Selection Of

Allogeneic hematopoietic cell transplantation (HCT) offers the only potential cure for patients with myelodysplastic syndromes (MDS). However, with current approaches to HCT, many older patients with comorbidities are poor HCT candidates, and treatment-related morbidity and mortality may offset benefit for patients with lower-risk disease. Consequently, selection of patients with MDS for HCT should take into consideration disease risk category including mutational status, HCT comorbidity index, functional status, donor options, and available institutional resources. Formal geriatric assessment may further guide use of HCT and, if HCT is chosen, selection of conditioning intensity. Patients with higher-risk MDS should be considered for HCT at the time of diagnosis, whereas expectant nontransplant management is more appropriate for those with lower-risk disease. A high blast burden at the time of HCT increases the risk of subsequent relapse; however, the role of pretransplant cytoreductive therapy and the regimen of choice remain controversial. Patients with MDS younger than 65 years and with an HCT comorbidity index ≤ 4 may benefit from more intense conditioning regimens. The presence of complex or monosomal karyotype or mutations in TP53, DNMT3A, or other genes identify patients with poorer outcomes following HCT. Patients with TP53 mutations have particularly poor survival, and should be enrolled in clinical trials whenever possible. Several important HCT studies are ongoing and will better define the role of HCT in MDS as well as the value of pretransplant cytoreductive therapy or post-transplant relapse-prevention strategies. Given the apparent underuse of HCT in eligible patients and low enrollment in MDS HCT clinical trials to date, timely referral of patients with MDS to such trials and HCT programs is critical.

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