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  • 1
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    Efficacy of Mesenchymal Stem Cells in Bronchiolitis Obliterans Syndrome after Allogeneic HSCT: A Multicenter Prospective Cohort Study
    American Society of Hematology ; 2019
    In:  Blood Vol. 134, No. Supplement_1 ( 2019-11-13), p. 871-871
    Details
    In: Blood, American Society of Hematology, Vol. 134, No. Supplement_1 ( 2019-11-13), p. 871-871
    Abstract: Background: Bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a devastating complication with limited therapeutic options. We aimed to assess the efficacy and safety of mesenchymal stem cells (MSCs) in BOS after allo-HSCT. Methods: Eighty-one allo-HSCT recipients with BOS diagnosed within 6 months were enrolled in this multicenter prospective cohort study. The choice of prednisone and azithromycin combined with or without MSCs was based on patient preferences (MSC n=49, non-MSC n=32). The primary endpoint was response rate at 3 months, defined as the proportion of patients achieving FEV1 improvement or steroid sparing. This trial was registered at ClinicalTrials.gov, NCT02543073. Results: Response rate was 35/49 patients (71%, 95% confidence intervals [CI] 59 to 84%) (FEV1 improvement n=10, steroid sparing n=25) and 14/32 (44%, 95% CI 27 to 61%) (FEV1 improvement n=3, steroid sparing n=11) in the MSC and non-MSC group, respectively (p=0.013). The adjusted odds ratio of response in the MSC group compared with the non-MSC group was 3.32 (95% CI 1.21-9.11; p=0.02). The addition of MSCs was associated with a better difference for change in FEV1 rate of decline, compared to non-MSC group (53 ml/months, 2 to 103; p=0.040). The 3-year overall survival post-diagnosis was 70.6% (95% CI 55.9 to 85.3%) and 58.2% (95% CI 36.1 to 78.5%) in the MSC and non-MSC group, respectively (p=0.21). Clinical improvement was accompanied by a significant increase of interleukin (IL)-10-producing CD5+ B cells. The incidences of infection and leukemia relapse were no significant difference between two groups. Multiple infusions of MSCs were well-tolerated with no serious adverse events. Interpretation: MSCs might be an effective and safe therapy for BOS patients after allo-HSCT. Our study strengthens evidence for clinical practice of MSC therapy in BOS. These data also offer insight into potential biological mechanisms of MSC treatment and support further investigation in larger randomized controlled trials. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2019-124455
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2019
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  • 2
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    Mesenchymal stromal cells plus basiliximab, calcineurin inhibitor as treatment of steroid-resistant acute graft-versus-host disease: a multicenter, randomized, phase 3, open-label trial
    Springer Science and Business Media LLC ; 2022
    In:  Journal of Hematology & Oncology Vol. 15, No. 1 ( 2022-03-07)
    Details
    In: Journal of Hematology & Oncology, Springer Science and Business Media LLC, Vol. 15, No. 1 ( 2022-03-07)
    Abstract: Steroid-resistant (SR) acute graft-versus-host disease (aGVHD) lacks standard second-line treatment. Mesenchymal stromal cells (MSCs) have potential efficacy in SR aGVHD. We aimed to assess the efficacy and safety of MSCs combined with basiliximab and calcineurin inhibitor as second-line therapy for SR aGVHD. Methods A randomized phase 3 trial involved 203 SR aGVHD patients at nine centers in China (September 2014–March 2019). Participants were randomized at a 1:1 ratio to receive second-line therapy with ( n  = 101) or without ( n  = 102) MSCs. The primary endpoint was the overall response (OR) at day 28. Secondary and safety endpoints included durable OR at day 56, failure-free survival, overall survival (OS), chronic GVHD (cGVHD), infection, hematological toxicity and relapse. Results Of 203 patients, 198 (97.5%; mean age, 30.1 years; 40.4% women) completed the study. The OR at day 28 was higher in the MSC group than the control group (82.8% [82 patients] vs. 70.7% [70] ; odds ratio, 2.00; 95% confidence interval [CI], 1.01–3.94; P  = 0.043). The durable OR at day 56 was also higher in the MSC group (78.8% [78 patients] vs. 64.6% [64] ; odds ratio, 2.02; 95% CI, 1.08–3.83; P  = 0.027). The median failure-free survival was longer in the MSC group compared with control (11.3 months vs. 6.0 months; hazard ratio (HR) 0.68; 95% CI, 0.48–0.95, P  = 0.024). The 2-year cumulative incidence of cGVHD was 39.5% (95% CI, 29.3–49.4%) and 62.7% (51.4–72.1%) in the MSC and control groups (HR 0.55, 95% CI, 0.36–0.84; P  = 0.005). Within 180 days after study treatments, the most common grade 3 and 4 adverse events were infections (65 [65.7%] in the MSC group vs. 78 [78.8%] in the control group) and hematological toxicity (37 [37.4%] vs. 53 [53.5%] ). The 3-year cumulative incidence of tumor relapse was 10.1% (95% CI, 5.2–17.1) and 13.5% (7.5–21.2%) in the MSC and control groups, respectively (HR 0.75, 95% CI, 0.34–1.67, P  = 0.610). Conclusions MSCs plus second-line treatments increase the efficacy of SR aGVHD, decrease drug toxicity of second-line drugs and cGVHD without increasing relapse, and are well-tolerated. MSCs could be recommended as a second-line treatment option for aGVHD patients. Trial registration clinicaltrials.gov identifier: NCT02241018. Registration date: September 16, 2014, https://clinicaltrials.gov/ct2/show/NCT02241018 .
    Type of Medium: Online Resource
    ISSN: 1756-8722
    URL: Article
    DOI: 10.1186/s13045-022-01240-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2429631-4
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  • 3
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    The efficacy of mesenchymal stem cells in bronchiolitis obliterans syndrome after allogeneic HSCT: A multicenter prospective cohort study
    Elsevier BV ; 2019
    In:  eBioMedicine Vol. 49 ( 2019-11), p. 213-222
    Details
    In: eBioMedicine, Elsevier BV, Vol. 49 ( 2019-11), p. 213-222
    Type of Medium: Online Resource
    ISSN: 2352-3964
    URL: Article
    DOI: 10.1016/j.ebiom.2019.09.039
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
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  • 4
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    Herpesvirus Infections of Intestinal Tract in the Patients with Intestinal Graft-Versus-Host Diseases: Laboratory Diagnosis Based on DNA Detection By Real-Time Quantitative PCR in Feces Samples
    American Society of Hematology ; 2021
    In:  Blood Vol. 138, No. Supplement 1 ( 2021-11-05), p. 1793-1793
    Details
    In: Blood, American Society of Hematology, Vol. 138, No. Supplement 1 ( 2021-11-05), p. 1793-1793
    Abstract: Background: Intestinal herpesvirus disease remains one of the major causes of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT). There is lack of useful methods for etiological diagnosis of intestinal herpesvirus diseases. Here, we evaluated the efficiency of detecting herpesvirus in feces samples via real-time quantitative PCR (RQ-PCR) for diagnosis of intestinal herpesvirus diseases after allo-HSCT. Methods: This was a multicenter, prospective study. Patients with refractory diarrhea after intestinal graft-versus-host diseases (GVHD) were enrolled in this study. Laboratory tests which consisted of morphologic examination, immunohistochemistry, in situ hybridization, and RQ-PCR of tissue homogenate were used to detect viral pathogens including cytomegalovirus (CMV), epstein-Barr virus (EBV), herpes simplex virus (HSV)-I, HSV-II, varicella zoster virus (VZV), adenovirus (ADV) and human herpes virus (HHV)-6, HHV-7. These viruses aforementioned were also detected in feces and blood samples. Results: One hundred and seven patients with refractory diarrhea after intestinal GVHD were enrolled between January 2016 and December 2020. Based on the detection of viruses in biopsy specimens, 75 patients were diagnosed as intestinal infectious diseases including 64 accompanying with intestinal GVHD. CMV was the most frequent pathogen of intestinal infectious diseases (53.8%), followed by EBV (36.5%), bacteria (3.4%) and others (6.3%). For diagnosis of intestinal CMV diseases, the sensitivity and specificity of RQ-PCR in feces samples were better than those of blood (sensitivity: 96.9% v.s. 72.5%, p=0.004; specificity: 93.6% v.s. 75.8%, p=0.035). Similarly, the sensitivity of RQ-PCR in feces and blood samples were 88.2% and 21.9% (p & lt;0.001) and the specificity were 98.5% and 86.3% (p=0.032) for diagnosis of intestinal EBV diseases. Conclusion: Intestinal infectious diseases were one of the main causes of refractory diarrhea after intestinal GVHD. Herpesviruses, especially CMV and EBV, were the most common pathogens. Herpesvirus-DNA detection by RQ-PCR in feces samples was a useful diagnostic method for intestinal herpesviruses diseases. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2021-148962
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2021
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 5
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    PASS‐ALL study of paediatric‐inspired versus adult chemotherapy regimens on survival of high‐risk Philadelphia‐negative B‐cell acute lymphoblastic leukaemia with allogeneic haematopoietic stem cell transplantation
    Wiley ; 2024
    In:  British Journal of Haematology Vol. 204, No. 2 ( 2024-02), p. 628-637
    Details
    In: British Journal of Haematology, Wiley, Vol. 204, No. 2 ( 2024-02), p. 628-637
    Abstract: This PASS‐ALL study was designed to explore the effect of paediatric‐inspired versus adult chemotherapy regimens on survival of adolescents and young adults (AYA) with high‐risk Philadelphia chromosome‐negative B‐cell acute lymphoblastic leukaemia (HR PH‐ve B‐cell ALL) eligible for allogeneic haematopoietic stem cell transplantation (allo‐HSCT). The PASS‐ALL study is a multicentre, observational cohort study, and 143 patients with HR B‐cell PH‐ve ALL were enrolled from five centres—77 patients allocated in the paediatric‐inspired cohort and 66 in the adult cohort with comparable baseline characteristics. Of the 143 patients, 128 cases underwent allo‐HSCT. Three‐year leukaemia‐free survival (LFS) in the paediatric‐inspired cohort was 72.2% (95% CI 60.8%–83.6%) compared with 44.6% (95% CI 31.9%–57.3%; p = 0.001). Furthermore, time‐to‐positive minimal residual disease (TTP‐MRD) post‐HSCT was marked different, 3‐year cumulative incidence of relapse was 25.9% (95% CI 15.8%–37.2%) in paediatric cohort and 45.4% (95% CI 40.0%–57.9%) in adult cohort ( p = 0.026). Finally, the 3‐year OS rate was 75.3% (95% CI 64.9%–85.7%) for the paediatric‐inspired cohort and 64.1% (95% CI 51.8%–76.4%) for the adult cohort ( p = 0.074). On a multivariate analysis, paediatric‐inspired regimen is a predictive factor for LFS (HR = 2.540, 95% CI 1.327–4.862, p = 0.005). Collectively, our data suggest that paediatric‐inspired chemotherapy pre‐HSCT results in deeper and durable MRD response reduces relapse post‐HSCT and improves survival in HR B‐cell PH‐ve ALL patients with allo‐HSCT.
    Type of Medium: Online Resource
    ISSN: 0007-1048 , 1365-2141
    URL: Issue
    URL: Article
    DOI: 10.1111/bjh.v204.2
    DOI: 10.1111/bjh.19223
    RVK:
    XA 34100
    Language: English
    Publisher: Wiley
    Publication Date: 2024
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  • 6
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    Mesenchymal Stromal Cells Plus Anti-CD25 Antibody and Calcineurin Inhibitors for Steroid-Resistant Acute Graft-Versus-Host Disease: A Multicenter, Randomized, Phase 3 Trial
    American Society of Hematology ; 2021
    In:  Blood Vol. 138, No. Supplement 1 ( 2021-11-05), p. 260-260
    Details
    In: Blood, American Society of Hematology, Vol. 138, No. Supplement 1 ( 2021-11-05), p. 260-260
    Abstract: INTRODUCTION Steroid-resistant (SR) acute graft-versus-host disease (aGVHD) lacks standard second-line treatment. Mesenchymal stromal cells (MSCs) have potential efficacy in SR aGVHD. To assess efficacy and safety of MSCs combined with anti-CD25 antibody and calcineurin inhibitors as second-line therapy for SR aGVHD. METHORDS A randomized phase 3 trial involved 203 SR aGVHD patients at 10 centers in China (September 2014-March 2019). Final follow-up was on June 30, 2020. Participants were randomized in a 1:1 ratio to receive second-line therapy (anti-CD25 antibody combined with calcineurin inhibitors) with MSCs (n=101) or without MSCs (n=102). The primary endpoint was overall response (OR) at day 28 with a predefined threshold of -20%. Secondary and safety endpoints included durable OR at day 56, failure-free survival, overall survival (OS), chronic GVHD (cGVHD), infection, haematological toxicity and relapse. RESULTS Of 203 patients, 198 (97.5%; mean age, 30.1years; 40.4% women) completed the study. OR at day 28 was higher in the MSCs group than in the control group (82.8% [82 patients] vs 70.7% [70] ; odds ratio, 2.00; 95% confidence interval [CI], 1.01-3.94; P=.043). Durable OR at day 56 was also higher in the MSCs group (78.8% [78 patients] vs. 64.6% [64]; odds ratio, 2.02; 95% CI, 1.08-3.83; P=.027). The median failure-free survival was longer in the MSCs group compared with control group (11.3 months vs. 6.0 month; hazard ratio (HR) 0.68; 95% CI, 0.48-0.95, P=.024). The 2-year cumulative incidence of cGVHD was 39.5% (95% CI, 29.3%-49.4%) and 62.7% (51.4%-72.1%) in the MSCs and control groups (HR 0·55, 95% CI, 0·36-0·84; P=0·005). Within 180 days after study treatments, the most common grade 3 and 4 adverse events were infections (65 [65.7%] in the MSCs group vs 78 [78.8%] in the control group), haematological toxicity (37 [37.4%] vs 53 [53.5%]). CONCLLUSIONS MSCs plus second-line treatments may increase the efficacy of SR aGVHD, decrease drug toxicity of second-line therapy and cGVHD development, and are well tolerated. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2021-146739
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2021
    detail.hit.zdb_id: 1468538-3
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  • 7
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    Busulfan Plus Cyclophosphamide Versus Total Body Irradiation Plus Cyclophosphamide for Adults Acute B Lymphoblastic Leukemia: An Open-Label, Multicenter, Phase III Trial
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 2 ( 2023-01-10), p. 343-353
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 2 ( 2023-01-10), p. 343-353
    Abstract: It remains controversial whether busulfan-based versus total body irradiation (TBI)–based regimens have comparable outcomes in patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem-cell transplantation (allo-HSCT). We investigated the efficacy and toxicity of busulfan plus cyclophosphamide (BuCy) and TBI plus cyclophosphamide (TBI-Cy) conditioning in allo-HSCT for adult standard-risk B-cell-ALL in first complete remission (CR1). PATIENTS AND METHODS We performed an open-label, randomized phase III trial at 13 hospitals in China. Eligible patients (age 14-65 years) had standard-risk ALL in CR1. Patients were randomly assigned (1:1) to BuCy (0.8 mg/kg four times per day on days –7 to –4 and cyclophosphamide 60 mg/kg once daily on days –3 to –2) or TBI-Cy (4.5 Gy TBI on days –5 to –4 and cyclophosphamide 60 mg/kg once daily on days –3 to –2). The primary end point was 2-year overall survival. Analysis was per protocol. This trial is registered with ClinicalTrials.gov (identifier: NCT02670252 ) and is complete. RESULTS Between January 2016 and February 2020, 275 patients were assigned to receive BuCy (273 assessed) and 275 to TBI-Cy (272 assessed). The 2-year overall survival was 76.6% (95% CI, 71.7 to 81.8) and 79.4% (74.7 to 84.4; P = .457; difference 2.9%; 95% CI, –4.1 to 9.8; P = .022), indicating noninferiority of BuCy. The 2-year relapse was 20.2% (95% CI, 15.6 to 25.1) and 18.4% (14.0 to 23.2; P = .616), and the nonrelapse mortality was 11.0% (95% CI, 7.6 to 15.0) and 11.0% (7.7 to 15.1; P = .988) in the BuCy and TBI-Cy groups, respectively. There were no differences in regimen-related toxicity, graft-versus-host disease, or late effects between the two groups. CONCLUSION The BuCy regimen has noninferior efficiency and safety as TBI-Cy (4.5 Gy × 2) for patients with adult standard-risk B cell-ALL in CR1 undergoing HLA-matched allo-HSCT.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.22.00767
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Haploidentical transplantation has a superior graft-versus-leukemia effect than HLA-matched sibling transplantation for Ph– high-risk B-cell acute lymphoblastic leukemia
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Chinese Medical Journal Vol. 135, No. 8 ( 2021-11-30), p. 930-939
    Details
    In: Chinese Medical Journal, Ovid Technologies (Wolters Kluwer Health), Vol. 135, No. 8 ( 2021-11-30), p. 930-939
    Abstract: Compared with human leukocyte antigen (HLA)-matched sibling donor (MSD) transplantation, it remains unclear whether haploidentical donor (HID) transplantation has a superior graft-versus-leukemia (GVL) effect for Philadelphia-negative (Ph–) high-risk B-cell acute lymphoblastic leukemia (B-ALL). This study aimed to compare the GVL effect between HID and MSD transplantation for Ph– high-risk B-ALL. Methods: This study population came from two prospective multicenter trials (NCT01883180, NCT02673008). Immunosuppressant withdrawal and prophylactic or pre-emptive donor lymphocyte infusion (DLI) were administered in patients without active graft-versus-host disease (GVHD) to prevent relapse. All patients with measurable residual disease (MRD) positivity posttransplantation (post-MRD+) or non-remission (NR) pre-transplantation received prophylactic/pre-emptive interventions. The primary endpoint was the incidence of post-MRD+. Results: A total of 335 patients with Ph– high-risk B-ALL were enrolled, including 145 and 190, respectively, in the HID and MSD groups. The 3-year cumulative incidence of post-MRD+ was 27.2% (95% confidence interval [CI]: 20.2%–34.7%) and 42.6% (35.5%–49.6%) in the HID and MSD groups (P  = 0.003), respectively. A total of 156 patients received DLI, including 60 (41.4%) and 96 (50.5%), respectively, in the HID and MSD groups ( P  = 0.096). The 3-year cumulative incidence of relapse was 18.6% (95% CI: 12.7%–25.4%) and 25.9% (19.9%–32.3%; P  = 0.116) in the two groups, respectively. The 3-year overall survival (OS) was 67.4% (95% CI: 59.1%–74.4%) and 61.6% (54.2%–68.1%; P  = 0.382), leukemia-free survival (LFS) was 63.4% (95% CI: 55.0%–70.7%) and 58.2% (50.8%–64.9%; P  = 0.429), and GVHD-free/relapse-free survival (GRFS) was 51.7% (95% CI: 43.3%–59.5%) and 37.8% (30.9%–44.6%; P  = 0.041), respectively, in the HID and MSD groups. Conclusion: HID transplantation has a lower incidence of post-MRD+ than MSD transplantation, suggesting that HID transplantation might have a superior GVL effect than MSD transplantation for Ph– high-risk B-ALL patients. Trial registration: ClinicalTrials.gov: NCT01883180, NCT02673008.
    Type of Medium: Online Resource
    ISSN: 0366-6999 , 2542-5641
    URL: Article
    DOI: 10.1097/CM9.0000000000001852
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2108782-9
    SSG: 6,25
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  • 9
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    Haploidentical versus HLA-matched sibling transplantation for refractory acute leukemia undergoing sequential intensified conditioning followed by DLI: an analysis from two prospective data
    Springer Science and Business Media LLC ; 2020
    In:  Journal of Hematology & Oncology Vol. 13, No. 1 ( 2020-12)
    Details
    In: Journal of Hematology & Oncology, Springer Science and Business Media LLC, Vol. 13, No. 1 ( 2020-12)
    Abstract: Compared with HLA-matched sibling donor (MSD) transplant, the outcomes of haploidentical donor (HID) transplant for refractory acute leukemia need to be further explored. In this study, we compared the outcomes of HID with MSD for refractory acute leukemia. Patients and methods This study population came from two prospective multicenter trials (NCT01883180, NCT02673008). Two hundred and seventy-eight patients with refractory acute leukemia were enrolled in this study, including 119 in HID group and 132 in MSD group. Sequential intensified conditioning was employed in all patients, and donor lymphocyte infusion (DLI) was administered in patients in the absence of active GVHD and according to minimal residual disease (MRD) from day + 60 post-transplantation for preventing relapse. Results The complete remission of leukemia by day + 30 post-transplant were 94% and 93%, respectively, in HID and MSD groups ( p = .802). The 1-year incidence of grades II–IV acute GVHD was 62% and 54% ( p = .025), and 3-year incidence of chronic GVHD was 55% and 55% ( p = .789), respectively, in two groups. HID transplant had lower incidence of first episode of MRD positivity and relapse than MSD transplant (28% vs 45%, p = .006; 26% vs 38%, p = .034). There was higher infection-related mortality in HID than MSD (8% vs 2%, p = .049) within the first 100 days’ post-transplant. The 5-year overall survival was 46% and 42% ( p = .832), respectively; the 5-year disease-free survival was 43% and 39% ( p = .665), in HID and MSD groups, respectively. Conclusions HID transplant has lower relapse, but higher infection-related mortality and similar survival rates in refractory acute leukemia by the strategy of sequential intensified conditioning followed by DLI compared with MSD transplant.
    Type of Medium: Online Resource
    ISSN: 1756-8722
    URL: Article
    DOI: 10.1186/s13045-020-00859-5
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
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  • 10
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    The Efficacy of Mesenchymal Stem Cells in Bronchiolitis Obliterans Syndrome after Allogeneic HSCT: A Multicentre Prospective Cohort Study
    Elsevier BV ; 2019
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.3411733
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
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