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  • 1
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    Chronic graft-versus-host disease: long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti–T-cell globulin ATG-Fresenius
    American Society of Hematology ; 2011
    In:  Blood Vol. 117, No. 23 ( 2011-06-09), p. 6375-6382
    Details
    In: Blood, American Society of Hematology, Vol. 117, No. 23 ( 2011-06-09), p. 6375-6382
    Abstract: Previous randomized graft-versus-host disease (GVHD)-prophylaxis trials have failed to demonstrate reduced incidence and severity of chronic GVHD (cGVHD). Here we reanalyzed and updated a randomized phase 3 trial comparing standard GVHD prophylaxis with or without pretransplantation ATG-Fresenius (ATG-F) in 201 adult patients receiving myeloablative conditioning before transplantation from unrelated donors. The cumulative incidence of extensive cGVHD after 3 years was 12.2% in the ATG-F group versus 45.0% in the control group (P 〈 .0001). The 3-year cumulative incidence of relapse and of nonrelapse mortality was 32.6% and 19.4% in the ATG-F group and 28.2% and 33.5% in the control group (hazard ratio [HR] = 1.21, P = .47, and HR = 0.68, P = .18), respectively. This nonsignificant reduction in nonrelapse mortality without increased relapse risk led to an overall survival rate after 3 years of 55.2% in the ATG-F group and 43.3% in the control group (HR = 0.84, P = .39, nonsignificant). The HR for receiving immunosuppressive therapy (IST) was 0.31 after ATG-F (P 〈 .0001), and the 3-year probability of survival free of IST was 52.9% and 16.9% in the ATG-F versus control, respectively. The addition of ATG-F to standard cyclosporine, methotrexate GVHD prophylaxis lowers the incidence and severity of cGVHD, and the risk of receiving IST without raising the relapse rate. ATG-F prophylaxis reduces cGVHD morbidity.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2011-01-329821
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
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  • 2
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    A Randomized Prospective Multicenter Phase III Trial Comparing Standard GvHD Prophylaxis with Cyclosporine and Methotrexate with Additional Pretransplant ATG Fresenius (ATG-F) in Allogeneic Stem Cell Transplantation from Matched Unrelated Donors
    American Society of Hematology ; 2008
    In:  Blood Vol. 112, No. 11 ( 2008-11-16), p. 57-57
    Details
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 57-57
    Abstract: Graft versus host disease is a major cause of morbidity and mortality after allogeneic stem cell transplantation from unrelated donors. Strategies using intensified GvHD prophylaxis including T cell depletion did not result in better outcome due to increased risks of infection and relapse. The use of ATG in the conditioning regimen for in vivo-Tcell depletion for GVHD prophylaxis has been reported by several groups but not been tested in a large prospective randomized trial. Here we report on results from the first large prospective, randomized, multicenter, open-label, phase III trial comparing standard GvHD prophylaxis with cyclosporine A (CyA) and short course methotrexate (Mtx) days +1, +3, +6, +11 (15/10/10/10 mg/m2) with or without 3×20mg/kg ATG-Fresenius (ATG-F) after a median follow-up time of two years. Between 2003 and 2007, 201 patients, median age 40 (range 18–60) years with AML (n=101), MDS (n=10), ALL (n=70), CML (n=17), OMF (n=3) in early (1st CR or MDS-RA, n=107), or advanced status of disease (all other, n=94), were transplanted from HLA-A and -B (2 digit), DRB1, DQB1 (4 digit) identical unrelated donors after highdose myeloablative conditioning with marrow (n=37) or PBSC (n=164) grafts. Median follow up time was 732.5 (25%-quartile 604, 75%-quartile 1097) days. For treatment comparisons with regard to the occurrence of aGvHD grade III-IV or death within 100 days post Tx, logistic regression adjusted for status of disease, source of stem cells, and center was used. For treatment comparisons with regard to time-to-event variables, cumulative incidence rates considering relapse and death as competing events were estimated, and Cox regression modelling the event-specific hazard rates and adjusting for status of disease and source of stem cells was used. Engraftment with WBC & gt; 1000/μl was achieved in 97% in the ATG-F group after median 26 days, and in 95% in the control group after median 19 days (p & lt;0.0001). At day +100, the rate of patients experiencing the primary efficacy endpoint-severe aGvHD (grade III–IV) or death - was 21.4% in the CyA/Mtx/ATG-F arm versus 33.7% in the CyA/Mtx only arm (p=0.1286). Incidence of grade III–IV acute GvHD was 11.7% in the ATG-F arm and 24.5% in the control group (p=0.054), grade II–IV aGvHD was 33.0% vs. 51.0% (p=0.0108), and grade I–IV aGvHD was 56.3% vs. 74.5% (p=0.0073). Incidence of chronic GvHD (limited and extensive) after two years was 30.8% in the ATG-F group versus 58.8% in the control group (p & lt;0.0001). Incidence of extensive chronic GvHD after two years was 12.2% in the ATG-F group versus 42.6% in the control group (p & lt;0.0001). Disease-free survival (DFS) after two years was 51.6% in the ATG-F and 47.5% in the control group (p=0.65). Incidence of relapse/progression after two years was 28.9% in the ATG-F and 23.6% in the control group (p=0.55). Incidence of death without former relapse/progression (TRM) after two years was 19.6% in the ATG-F and 28.9% in the control group (p=0.198). Overall survival (OS) after two years was 59.2% in the ATG-F and 51.9% in the control group (p=0.47). Number of infections per follow up year was 4.54 in the ATG-F and 4.76 and in the control group. The addition of ATG-F to standard CyA/Mtx prophylaxis results in decreased incidence of acute and chronic GvHD without increase of relapse or TRM rates. This is the first randomized trial answering the long-standing question regarding the beneficial effect of additional ATG-F to a standard GvHD prophylaxis. A reduction of GvHD without compromising survival could be demonstrated.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V112.11.57.57
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
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  • 3
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    An Intergroup Randomised Trial of Standard Intensity Versus Reduced Intensity TBI-Based Conditioning In Patients with Acute Myeloid Leukemia in First Complete Remission
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 157-157
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 157-157
    Abstract: Abstract 157 Allogeneic hematopoietic cell transplantation (HCT) remains the treatment approach with the lowest risk of relapse in patients with intermediate or high-risk acute myeloid leukemia (AML). The lower incidence of relapse achieved with allogeneic HCT is sometimes offset by the higher rate of transplant-related deaths mainly occurring during the first 12–24 months after the procedure. With the advent of reduced-intensity conditioning regimens, older and less fit patients have become eligible for allogeneic HCT. But still, there is some debate as to the optimum level of conditioning intensity in order to reduce non-relapse mortality without jeopardizing overall cytoreductive efficacy. Stimulated by the promising results of a phase II trial exploring the efficacy and toxicity of a regimen combining Fludarabine 30 mg/m2 for four days combined with 800 cGy fractionated total-body irradiation (TBI), we designed this study to compare the mentioned regimen with standard-intensity conditioning. Adult patients with AML in first complete remission (CR1) with standard or high-risk cytogenetics were randomly assigned with a ratio 1:1 to standard intensity conditioning (6 × 200 cGy TBI (1200cGy) over 3 days and Cyclophosphamide 60 mg/kg per day over 2 days (Arm A)) or TBI 4 × 200 cGy (800 cGy) combined with Fludarabine 30 mg/m2 daily over 4 days (Arm B). Antithymocyte globuline was infused at a cumulative dose of 60 mg/kg (3 × 20 mg/kg from day -3 to -1) in recipients of grafts from unrelated donors (UD). Pharmacologic prophylaxis of graft-versus-host disease (GvHD) was performed with CsA starting day -1 and Mtx on days 1, 3, 6 and 11. The primary endpoint was transplant-related mortality (TRM) within the first 12 months after transplantation Secondary end-points included overall as well as disease-free survival and acute and chronic GvHD. Between November 2004 and December 2009, 198 patients were registered in the trial. Three patients had to be excluded for the violation of inclusion criteria. The intent-to-treat (ITT) population, thus, consisted of 195 subjects (96 Arm A, 99 Arm B). Eleven patients did not receive the study treatment. Therefore, the per protocol analyses involved 184 patients (90 Arm A, 94 Arm B). Median age was 45 years (range 18–60). 46% were female. Intermediate risk and high risk karyotypes were present in 62% and 38% of the patients, respectively. 60% of the patients received grafts from matched sibling donors. Grafts from UD with at least 9 out of 10 HLA alleles (HLA-A, B, C, DRB1, DQB1) were infused in 40%. The majority of patients (89%) received G-CSF mobilised peripheral blood stem cells. Donor type, cytogenetic risk, type of induction regimen and age (18–40 vs. 〉 40) had been strata for randomisation and were therefore well balanced between both groups. Most patients had received double induction therapy using 3+7 combinations of anthracyclines and cytarabine. The evaluation of the primary endpoint in the per protocol population showed a lower incidence of TRM after 12 months in Arm B (8%, 95% Confidence interval (CI) 3–14% versus 17%, CI 9–24% in Arm A, p=0.048; ITT p=0.06). The difference in TRM at 12 months was even more pronounced in the subgroup of patients 〉 40 years (5% Arm B versus 20% Arm A, p=0.01). With a median follow-up of 27 (range 4–81) months for patients alive, the probability of overall survival three years after randomisation was 62 % in the reduced-intensity Arm B versus 59% in Arm A (p=0.28). Probabilities of disease-free survival were 60% and 56% for Arm B and Arm A (p=0.44), respectively. The cumulative incidence of grade II-IV acute GvHD until day 100 was 16% in Arm B versus 23% in Arm A (p=0.15). Cumulative incidences of relapse three years after transplantation were not different between both treatment arms albeit a different kinetic of relapse could be documented. This trial shows for the first time in a prospectively randomized design in patients with AML in CR1 that reduced-intensity conditioning can result in significantly lower early TRM without increasing relapse risk. Fludarabine combined with 800cGy fractionated TBI can be regarded as a valid alternative to standard intensity conditioning even in younger patients with AML transplanted in first remission. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.157.157
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
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  • 4
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    Harnessing the Expression of TNFR2 on Tregs to Prevent Agvhd
    American Society of Hematology ; 2022
    In:  Blood Vol. 140, No. Supplement 1 ( 2022-11-15), p. 4465-4466
    Details
    In: Blood, American Society of Hematology, Vol. 140, No. Supplement 1 ( 2022-11-15), p. 4465-4466
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2022-168592
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2022
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  • 5
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    Infectious complications after allogeneic stem cell transplantation: epidemiology and interventional therapy strategies : Guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)
    Springer Science and Business Media LLC ; 2003
    In:  Annals of Hematology Vol. 82, No. S2 ( 2003-10), p. S175-S185
    Details
    In: Annals of Hematology, Springer Science and Business Media LLC, Vol. 82, No. S2 ( 2003-10), p. S175-S185
    Type of Medium: Online Resource
    ISSN: 0939-5555 , 1432-0584
    URL: Article
    DOI: 10.1007/s00277-003-0772-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2003
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  • 6
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    Prognostic Factors Affecting Outcome after Allogeneic Transplantation for Hematological Malignancies from Unrelated Donors: Results from a Randomized Trial
    Elsevier BV ; 2012
    In:  Biology of Blood and Marrow Transplantation Vol. 18, No. 11 ( 2012-11), p. 1716-1726
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 18, No. 11 ( 2012-11), p. 1716-1726
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2012.06.001
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2012
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    detail.hit.zdb_id: 2057605-5
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  • 7
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    Treatment of Steroid-Resistant Acute GvHD with OKT3 and High-Dose Steroids Versus High-Dose Steroids Alone.
    American Society of Hematology ; 2005
    In:  Blood Vol. 106, No. 11 ( 2005-11-16), p. 141-141
    Details
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 141-141
    Abstract: Despite new conditioning regimens and introduction of novel immunosuppressants in hematopoietic cell transplantation (HCT), acute graft-versus-host disease (aGvHD) remains an often life threatening complication. Methylprednisolone (MP) 2 mg/kg body weight (BW) per day is the initial standard treatment with escalation to high-dose MP (10 mg/kg BW per day) for non-responders. Recently, we demonstrated OKT3 muromonab to be an effective second-line and subsequent salvage treatment. Response duration, however, was frequently short-lived in those extensively pretreated patients and inversely correlated with duration from allografting. In the current randomized multicenter trial we investigated high-dose MP (HD-MP) versus OKT3 5 mg per day plus HD-MP. Primary endpoints were response to treatment after 100 days and survival at one year from HCT. Secondary endpoints were side effects and incidence of infectious complications. Patients with resistant °II to IV aGvHD on standard MP following allogeneic HCT were randomized to HD-MP or OKT3 + HD-MP after exclusion of other severe HCT-related complications. Eighty patients from 6 transplant centers were enrolled. Median age for the 40 patients who received OKT3 + HD-MP was 40 (range, 19 – 65) years and for the 40 patients who received HD-MP 39 (range, 19 – 56) years. There was no statistical significant difference between the groups for severity of aGvHD (°II vs. °III/IV); stem cell source (bone marrow vs. peripheral blood progenitor cells); GvHD prophylaxis (CSA vs. ATG+CSA); and conditioning regimen (TBI/Cy vs. Bu-Cy). However, significantly fewer HCTs in the OKT3 + HD-MP group were from HLA-identical siblings. Currently, 62 subjects are evaluable for response. In both arms, reduction of severe and proportional increase of moderately-severe aGvHD was observed with resolution of all °IV cases until day +30. However, significantly more patients in the OKT3 + HD-MP became disease-free (°0) by day +100 when compared to patients treated with HD-MP alone: 39.3 % vs. 20.6 % (p=0.03). In the OKT3 + HD-MP group relative increase of disease-free patients was higher for all organ systems at all time points when compared to patients on HD-MP treatment without reaching statistical. With respect to infectious complications, the incidence of both bacterial and viral infections was slightly and for invasive aspergillosis significantly higher in the HD-MP when compared to the OKT3 + HD-MP group (20.6 vs. 10.7 %; p=0.025). Treatment related mortality was higher in the HD-MP group when compared to the OKT3 + HD-MP group by days +30 (32.3 vs. 10.7 %) and +100 (55. 9 vs. 39.3 %). However, this did not translate into a significantly better one-year survival with the currently evaluable patients: one-year survival for the HD-MP group was 32.4 % and for the OKT3 + HD-MP group 46.4 %. (p=0.72). We conclude that OKT3 + HD-MP results in higher response rates for patients with steroid-resistant aGvHD and thus leads to a better immune reconstitution after HCT what is reflected by reduced incidence and mortality of infectious complications. Final results of the trial will be presented.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V106.11.141.141
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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  • 8
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    Allogeneic stem cell transplantation after reduced-intensity conditioning in patients with myelofibrosis: a prospective, multicenter study of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 26 ( 2009-12-17), p. 5264-5270
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 26 ( 2009-12-17), p. 5264-5270
    Abstract: From 2002 to 2007, 103 patients with primary myelofibrosis or postessential thrombocythemia and polycythemia vera myelofibrosis and a median age of 55 years (range, 32-68 years) were included in a prospective multicenter phase 2 trial to determine efficacy of a busulfan (10 mg/kg)/fludarabine (180 mg/m2)–based reduced-intensity conditioning regimen followed by allogeneic stem cell transplantation from related (n = 33) or unrelated donors (n = 70). All but 2 patients (2%) showed leukocyte and platelet engraftment after a median of 18 and 22 days, respectively. Acute graft-versus-host disease grade 2 to 4 occurred in 27% and chronic graft-versus-host disease in 43% of the patients. Cumulative incidence of nonrelapse mortality at 1 year was 16% (95% confidence interval, 9%-23%) and significantly lower for patients with a completely matched donor (12% vs 38%; P = .003). The cumulative incidence of relapse at 3 years was 22% (95% confidence interval, 13%-31%) and was influenced by Lille risk profile (low, 14%; intermediate, 22%; and high, 34%; P = .02). The estimated 5-year event-free and overall survival was 51% and 67%, respectively. In a multivariate analysis, age older than 55 years (hazard ratio = 2.70; P = .02) and human leukocyte antigen–mismatched donor (hazard ratio = 3.04; P = .006) remained significant factors for survival. The study was registered at www.clinicaltrials.gov as #NCT 00599547.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2009-07-234880
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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  • 9
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    Health-Related Quality of Life Impairment in Patients with Chronic Myeloid Leukemia: Results of a German Cross-Sectional Study of Patients Registered in Prospective, Controlled Clinical Trials
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 2773-2773
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 2773-2773
    Abstract: Introduction: With many treatment options for chronic myeloid leukemia (CML), endpoints like health-related quality of life (HRQoL) move into focus and might be essential for deciding on treatment strategies. We sought to evaluate HRQoL in CML patients who had been registered in four consecutive studies of the German CML study group. Methods: The EORTC QLQ-C30 questionnaire was used to assess HRQoL of CML patients. Functional scales and global health status were calculated in accordance with Aaronson (1993) and Fayers (2001). With scales ranging from 0 to 100, 8 points are regarded as a minimally important difference (Efficace et al., 2013). Baseline data of responders (R) and non-responders (NR) were compared. Associations between two variables were assessed by the Fisher or Mann-Whitney tests, as appropriate. The global health status and the functioning scores were compared between groups with the van Elteren test, if the groups were stratified for another variable. Furthermore, results of the global health status and the functioning scores in our sample were standardized in accordance with the age (18-29, 30-39, 40-49, 50-59, 60-69, ≥70 years) and sex distribution of the 2448 participants of the German HRQoL outcome study reported by Hinz et al. 2014. The outcome of our sample was then compared with the outcome of these 2448 patients representing QoL of the German population in general. Comparison was performed using a t test. Results: A questionnaire was sent to 1634 patients. During January to April 2011, 858 questionnaires (53%) were sent back. Compared to NR, R were older (median age: 55 vs. 58, p=0.0426); years since diagnosis (median 6.5 vs. 7.4) and the percentage that had been transplanted were lower (24%vs.18%). No differences were observed regarding sex, Euro score, or time after allogeneic hematopoietic stem cell transplantation (HSCT). When answering the questionnaire, 517 (60%) patients received imatinib 400mg (IM400) and 102 (12%) were off therapy after HSCT. Less than 10% of patients received imatinib 800mg, imatinib+AraC or interferon alpha, nilotinib, or dasatinib. Time since diagnosis was ≤3 years in 156 (18%), 〉 3 and ≤7 years in 309 (36%), and 〉 7 years in 393 (46%) of the patients. Women (352, 41%) perceived a significant reduction in global health status (mean: 62.7, p 〈 0.001), role (65.4, p=0.0016), emotional (60.3, p=0.0002), and physical functioning (74.9, p 〈 0.0001) when compared to males (68.9, 71.5, 67.6, and 82.7, respectively). In the latter two cases, this perception met the definition of a clinical relevance. Results on significance did not change with adjustment for age. Compared to the German population, the 858 CML patients had significantly lower scores for global health status (mean: 67.9, p 〈 0.0001), role (70.8, p 〈 0.0001), social (69.2, p 〈 0.0001), emotional (64.6, p 〈 0.0001), physical (81.0, p 〈 0.0001) and cognitive functioning (77.3, p 〈 0.0001). Only for global health status, the difference was below 8. To evaluate HRQoL in patients with long standing disease, 100 patients with diagnosis 〉 7 years off therapy after HSCT and 203 patients receiving IM400 were analyzed. Adjusted for age group and sex, CML patients receiving IM400 for more than 7 years had lower scores for global health status (mean: 63.8, p 〈 0.0001 ), role (66.7, p 〈 0.0001), social (68.8, p 〈 0.0001), emotional (64.0, p 〈 0.0001), physical (75.2, p 〈 0.0001) and cognitive functioning (68.0, p 〈 0.0001) than the German control population. With respect to all six HRQoL scores, significantly lower scores than from the German population were also observed for the CML patients being seven years without treatment after HSCT: global health status (mean: 69.2, p 〈 0.0001 ), role (68.6, p 〈 0.0001), social (67.5, p 〈 0.0001), emotional (68.1, p 〈 0.0001), physical (83.1, p 〈 0.0001) and cognitive functioning (71.2, p=0.0053). Conclusions: In this cross-sectional study, women showed an impaired global health status, role, emotional, and physical functioning compared to males. Considering all 858 CML patients, the HRQoL was significantly impaired in all scales when compared to the German population. The same results were observed for the subgroups of patients either receiving IM400 for at least 7 years or being off therapy 7 years after HSCT. Reduced HRQoL remains an issue for all patients after long-term TKI treatment or after HSCT. These data may serve as a basis to evaluate HRQoL in stopping studies in CML. Disclosures Saussele: BMS: Honoraria, Other: Travel grant, Research Funding; Novartis Pharma: Honoraria, Other: Travel grant, Research Funding; ARIAD: Honoraria; Pfizer: Honoraria, Other: Travel grant. Kremers:Novartis: Honoraria; Bristol Myers Squibb: Other: Travel costs, supporting educational meeting; Novartis: Other: supporting educational meeting. Hochhaus:Bristol-Myers Squibb: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; ARIAD: Honoraria, Research Funding. Müller:BMS: Honoraria, Other: Consulting or Advisory Role, Research Funding; Novartis: Honoraria, Other: CONSULTING OR ADVISORY ROLE, Research Funding; ARIAD Pharmaceuticals Inc.: Honoraria, Other: Consulting & Advisory Role, Research Funding. Hehlmann:Novartis Pharma: Research Funding; BMS: Consultancy. Pfirrmann:BMS: Consultancy, Honoraria; Novartis Pharma: Consultancy, Honoraria.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.2773.2773
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 10
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    Shift to a New Donor Does Not Improve the Outcome After Second Allogeneic Stem Cell Transplantation (alloSCT) in Acute Leukemia Relapse After a First Allosct – a Risk Factor Analysis by the German Stem Cell Registry (DRST).
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 3328-3328
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 3328-3328
    Abstract: Abstract 3328 Poster Board III-216 Introduction Relapse is a major cause of treatment failure after alloSCT against acute leukaemia, and no standard treatment has been established in this challenging situation. The introduction of reduced conditioning regimens, and the broader availability of alternative donors have increased the possibilities to perform a second alloSCT as salvage treatment, using different preparative regimen and/or different stem cell donors. Methods To evaluate the role of a second alloSCT (tx2) for the treatment of relapse after first alloSCT (tx1), we performed a nationwide retrospective analysis based on the German registry for stem cell transplantation (DRST). Datasets were completed by the reporting centres on request, following a specifically designed questionnaire. Results 212 patients (69% AML, 31% ALL), from 23 centres were included. Median age at tx1 was 37y. Donor at tx1 were HLA identical siblings (41%), matched unrelated (39%), mismatched family or unrelated (17%) or syngeneic donors (3%). Conditioning intensity at tx1 was standard (SIC, 62%), intermediate (intC, 25%) or reduced (RIC, 13%). Median remission after tx1 was 7 months, median time from relapse to tx2 was 74d. At tx2, patients were aplastic (4%), in CR (20%) or showed active disease (76%). In 59%, the same donor was used for tx1 and tx2, whereas a different donor was chosen in 41%. Conditioning at tx1/tx2 were SIC/SIC (14%), intC/intC (10%), (RIC/RIC (10%), less intensive at tx2 (mostly intC or RIC after SIC, 58%), or more intensive at tx2 (SIC after RIC or intC, 8%). Following tx2, CR was achieved in 56% of patients, out of which 81% relapsed again. Hence, leukemia was the most frequent cause of death. With a median FU of 23 months after tx2, median OS after tx2 is 117d. In a univariate analysis (log rank), OS after tx2 depended on stage at tx1 (CR vs. active disease, p 〈 .001), stage at tx2 (CR vs. aplastic/active disease, p=.011) and duration of remission after tx1 ( 〈 =6m (1y OS 5%) vs. 6-12m (15%) vs. 〉 12m (31%), p 〈 .001). No significant difference was observed regarding age ( median), AML vs. ALL, family versus unrelated donor, or time point of alloSCT (2002). Shift to an alternative donor did not improve the results either. In a multivariate analysis (Cox Regression Model), time of remission after tx1 was the only significant factor for OS (p 〈 .001, hazard ratio .51, 95%CI .49-.74). Conclusion Survival of acute leukemia after second allogeneic SCT is determined by the duration of remission after tx1. Using an alternative donor for tx2 did not improve the results in our series. Further analysis is required to evaluate the role of RIC regimen for tx2. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.3328.3328
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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