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  • 1
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    Induction with New Drugs and Planned Autologous Followed by Non-Myeloablative Allogeneic Transplantation in Newly Diagnosed Myeloma.
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 4330-4330
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 4330-4330
    Abstract: Abstract 4330 Introduction Immunomodulatory drugs have recently changed the treatment options in multiple myeloma. Moreover, thalidomide, bortezomib and lenalidomide have also been used in the setting of allografting as post-transplant salvage therapy or as maintenance. We are currently evaluating the impact of new drugs as induction therapy in newly diagnosed multiple myeloma before a planned standard autograft followed by a non-myeloablative allograft (Tandem auto-allo). Patients and methods Twenty-five newly diagnosed patients (median age 55 years old, range 26-65) entered a recently designed prospective phase II program of tandem auto-allo which included the use of so-called new drugs during induction. Here, we report data on the first 11 evaluable patients with a follow up of at least 1 month after the allograft. Induction consisted of lenalidomide and dexamethasone (n=5), thalidomide and dexamethasone (n=4), or bortemomib-containing regimens (n=2), followed by G-CSF mobilized peripheral blood stem cell harvest. A standard autograft after melphalan 200 mg/m2 was planned 2-4 months before a low-dose (2 Gy) TBI-based allograft from an HLA-identical sibling. GVHD prophylaxis consisted of cyclosporin and mycophenolate mofetil. Disease status at allografting and post-transplant outcomes were compared to those of 22 patients pair-matched for beta2microglobulin and age, who underwent tandem auto-allo after induction with VAD-based regimens without new drugs (Blood, 2009). Results At the time of allografting after induction with new drugs and the autograft overall response rate was 81% (9/11), including a immunofixation-negative complete remission (CR). Following allografting, all patients promptly achieved donor engraftment. After a median follow-up of 11 months (2-26), all patients are alive and the overall response rate was 91% (10/11). Incidence of grade II-IV GVHD was 34% (4/11), including 1 patient with grade III GVHD. Chronic GVHD was observed in 40% (4/10) of patients with at least 3 months of follow-up. The induction with new drugs did not increase allotransplant-related toxicity or incidence of acute GVHD (Table 1). We observed a higher response disease before allografting in patients treated with new drugs. Conclusions Induction with lenalidomide, thalidomide or bortezomib does not impact feasibility and safety of tandem auto-allo. Longer follow up and a larger cohort of patients are necessary to evaluate the impact of new drugs in improving disease control post-tandem auto-allo. Disclosures: Patriarca: Janssen Cilag: Honoraria; Celgene: Honoraria. Boccadoro:Celgene: Consultancy, advisory committees, Research Funding; Pharmion: Consultancy, advisory committees, Research Funding; Janssen Cilag: Consultancy, advisory committees, Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.4330.4330
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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  • 2
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    RIC Allogeneic Transplantation Improves the Overall and Progression- Free Survival of Hodgkin Lymphoma Patients Relapsing after Autologous Transplantation: A GITMO Retrospective Study Based on Time of HLATyping and Donor Availability
    American Society of Hematology ; 2008
    In:  Blood Vol. 112, No. 11 ( 2008-11-16), p. 460-460
    Details
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 460-460
    Abstract: Background: Hodgkin Lymphoma (HL) patients (pts) relapsing after autologous transplantation (auto-SCT) have a very poor outcome with no chemotherapy options able to obtain a long term disease control. Allogeneic stem cell transplantation (allo-SCT) employing reduced intensity conditioning (RIC) is increasingly used in lymphomas, but the number of studies in HL is quite limited, some groups reported conflicting results, and thus no clear evidence exists on its role as an effective salvage option in the clinical setting. Aims: We investigated the role of RIC allo-SCT in HL pts relapsing or progressing after auto-SCT (primary refractory patients were not included). Our study was structured similarly to an intent to treat analysis, and thus was based on the commitment of the attending physician to perform an allo-SCT. Only those pts undergoing a HLA-typing immediately after the failure of auto-SCT were included. The cohort of pts having a donor (donor group) was compared with the one not having a suitable donor (no donor group). Patients and Methods: 132 pts were retrospectively evaluated, for all of them a search for a sibling or matched unrelated donor (MUD) was started at the time of relapse/progression after auto-SCT. Seventy-five pts found a donor and 68 (90%) underwent an allo-SCT: 36 identical siblings (52%), 23 MUD (33%), 6 haploidentical family donors (9%). Thiotepa, cyclophosphamide and fludarabine containing regimens were used in all pts; GVHD prophylaxis was based on MTX and cyclosporine except for haploidentical-SCT. Seven pts having a donor did not receive allo-SCT for progressive disease. Pts not having a donor (n= 57) received chemo- and/or radiotherapy according to the standard policy of each center. The two cohorts of patients were well balanced in terms of clinical features, in particular the number of patients relapsing/progressing within 6 months from auto-SCT was similar. Results: The patient median age was 30 years (17–62). The median followup was 24 months. For all pts, the median overall (OS) and progression free survival (PFS) were 31 and 15 months, respectively. The 2-year OS and PFS were 56% and 29% respectively. The cumulative transplant-related mortality was 12% for the donor group. The 2-y OS and PFS were significantly better in the donor compared to the no donor group (OS 70% vs 38.8%, p 0.001, long rank test; PFS 42% vs 10%, p 0.03, long rank test). In multivariate analysis having a donor was statistically significant for OS and PFS. When we considered only the pts actually allografted, again the 2-years OS and PFS were significantly better compared to the no allo-group (OS 77% vs 35% and PFS 47% vs 9.3%). Acute GVHD grade II-IV occured in 17 pts (25)% and chronic GVHD in 27 pts ( 40%). In multivariate analysis, being in complete remission before allo-SCT significantly improved OS and PFS. Conclusions: This is the largest study comparing RIC allo-SCT vs conventional treatment in HL patients failing an auto-SCT. Allo-SCT is a feasible option and prolongs OS and PFS. As expected, the attainment of complete remission before allo-SCT improves the outcome.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V112.11.460.460
    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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    A Comparison of Allografting with Autografting for Newly Diagnosed Myeloma
    Massachusetts Medical Society ; 2007
    In:  New England Journal of Medicine Vol. 356, No. 11 ( 2007-03-15), p. 1110-1120
    Details
    In: New England Journal of Medicine, Massachusetts Medical Society, Vol. 356, No. 11 ( 2007-03-15), p. 1110-1120
    Type of Medium: Online Resource
    ISSN: 0028-4793 , 1533-4406
    URL: Article
    DOI: 10.1056/NEJMoa065464
    RVK:
    XA 10000
    Language: English
    Publisher: Massachusetts Medical Society
    Publication Date: 2007
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  • 4
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    Nonmyeloablative allogeneic stem cell transplantation in elderly patients with hematological malignancies: Results from the GITMO (Gruppo Italiano Trapianto Midollo Osseo) multicenter prospective clinical trial
    Wiley ; 2007
    In:  American Journal of Hematology Vol. 82, No. 10 ( 2007-10), p. 863-866
    Details
    In: American Journal of Hematology, Wiley, Vol. 82, No. 10 ( 2007-10), p. 863-866
    Abstract: This study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and TBI in patients aged ≥60 years.A total of 32 patients (median age 62 years; range 60–70) with hematological malignancies were treated with fludarabine (30 mg/m 2 × 3–5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched‐sibling donor. GVHD prophylaxis consisted of cyclosporine and mycophenolate. Neutrophil recovery occurred in all patients at a median time of 16 days (range 9–34). Six patients did not become granulocytopenic. On day +30, 10 patients had 〉 95% donor chimerism and 19 patients had mixed chimerism. The cumulative probabilities of Grade II–IV acute GVHD and chronic GVHD were 48 and 83%, respectively. Transplant‐related mortality at 100 days and 1 year was 6 and 10%, respectively. The probabilities of 2‐year overall (OS) and progression‐free survival (PFS) were 39 and 35%, respectively. The estimated 2‐year probability of OS and PFS for patients in early disease stages were 77 and 64%, respectively, which were significantly higher than the survival and PFS estimates of 0% obtained in patients with advanced disease stages at the time of transplant. Our analysis would suggest that for patients older than 60, this regimen is well tolerated and associated with a low incidence of transplant‐related mortality. The leukemic burden at time of transplant has proven to be the most important risk factor for the outcome. Am. J. Hematol. 82:863–866, 2007. © 2007 Wiley‐Liss, Inc.
    Type of Medium: Online Resource
    ISSN: 0361-8609 , 1096-8652
    URL: Issue
    URL: Article
    DOI: 10.1002/ajh.v82:10
    DOI: 10.1002/ajh.20990
    Language: English
    Publisher: Wiley
    Publication Date: 2007
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  • 5
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    Imatinib as Salvage Therapy for Patients with Refractory cGVHD: the Interim Analysis of the Prospective GITMO* Multicenter Study*Gruppo Italiano Trapianto Di Midollo Osseo.
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 3558-3558
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 3558-3558
    Abstract: Abstract 3558 Poster Board III-495 We recently reported in a pilot study, including 19 adult and pediatric patients affected by refractory cGvHD with fibrotic features, that the administration of Imatinib at low dose was well tolerated and effective, achieving an overall response rate (ORR) of 79% at 6 months; the response has been evaluated according to the modified Curiel Criteria. We report here the preliminary results of an Italian GITMO Multicenter study, aimed to confirm these promising data. Main objective of this study was to assess the response rate, evaluated according to the stringent criteria suggested by the NIH Consensus Conference for cGVHD and to confirm the safety of low dose Imatinib in this setting. Secondary objectives were both clinical and biological: 1-to evaluate the clinical outcome (OS at 1 and 2 years) and quality of life; 2-to test a reliable technique for screening these patients for the presence of stimulating anti-PDGFR antibodies before and after the end of Imatinib treatment. The study was planned as phase 2 trial (optimal two stages Simon design), and enrolled 24 patients with cGVHD, refractory to two or more lines of therapy, including steroids. Nine Italian Centres enrolled 24 adults patients, starting from February 2008 to August 2009; 18 patients are now evaluable for toxicity and for the response at 3 and 6 months; 13 were male and 5 female; the median age was 47 years (range 31-62). The median duration of cGVH was 36 (range 3-148) months and all patients received 2 or more lines of therapy; the main cGVH target was represented by lung in 9 patients (5 patients had severe abnormalities of the functional tests with compromised Lung Functional Score), skin in 8 patients and bowel in 8 patients. Most patients had multi-organ involvement. The treatment with Imatinib was planned for a minimum of 6 months, starting at the initial dose of 100 mg/day, then increasing the dose to 200 mg/day until 3rd month; if no response and in absence of severe toxicity, patients were allowed to receive 400 mg/day until 6th month. The response has been defined as CR or PR, and was evaluated after 3 and 6 months of therapy; the kind of response (CR or PR) was defined according to the Curiel criteria, integrated by the criteria suggested by the NIH Consensus Conference for cGVHD. Results the treatment was well tolerated (all patients were able to complete the treatment for at least 6 months) and we did not observe toxic deaths; the toxicity was mild (no grade 3-4 toxicities have been reported) and 3 Severe Adverse Events have been reported (3 cases of pneumonia), probably related to the immunesuppression due to cGVHD instead to the Imatinib treatment. The ORR at 3 months was 72% and 56% at 6 months (9 PR and 1CR); 3 patients were able to stop or significantly decrease steroids. With a median follow-up of 6 months 15 out of the 18 evaluable patients are alive while 3 died of progressive cGVHD. The preliminary results of this multicenter study confirm that low-dose Imatinib is safe and effective in patients affected by refractory cGVHD; the slightly lower response rate observed at 6 months, compared to the previous study probably reflects the different population enrolled: older patients in the present study (the median age was 47, compared to 27 in the previous study; absence of pediatric patients who showed the best responses), most of them with lung involvement (9) and 5 with severe impairment of Lung Functional Score. These data encourage the use of Thyrosin Kinase Inhibitors in patients with refractory cGVHD and the evaluation of these drugs in phase 3 trials; furthermore the extensive evaluation of biological activity of these drugs could be able to select those patients who could benefit of this approach. This study was supported by the Italian medicines Agency (AIFA) within the independent drug research program contract no. FARM7ZWZ7Y. Disclosures: Off Label Use: yes we report the results obtained with Imatinib off-label in patients with refractory cGVHD.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.3558.3558
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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  • 6
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    Imatinib for refractory chronic graft-versus-host disease with fibrotic features
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 3 ( 2009-07-16), p. 709-718
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 3 ( 2009-07-16), p. 709-718
    Abstract: We previously reported that patients with fibrotic, chronic graft-versus-host disease (cGVHD) have antibodies activating the platelet-derived growth factor receptor pathway. Because this pathway can be inhibited by imatinib, we performed a pilot study including 19 patients with refractory cGVHD, given imatinib at a starting dose of 100 mg per day. All patients had active cGVHD with measurable involvement of skin or other districts and had previously failed at least 2 treatment lines. Patient median age was 29 years (range, 10-62 years), and median duration of cGvHD was 37 months (range, 4-107 months). The organs involved were skin (n = 17), lung (n = 11), and bowel (n = 5); 15 patients had sicca syndrome. Imatinib-related, grade 3 to 4 toxicity included fluid retention, infections, and anemia. Imatinib was discontinued in 8 patients: in 3 because of toxicity and in 5 because of lack of response (n = 3) or relapse of malignancy (n = 2). Overall response rate at 6 months was 79%, with 7 complete remissions (CRs) and 8 partial remissions (PRs). With a median follow-up of 17 months, 16 patients are alive, 14 still in CR or PR. The 18-month probability of overall survival is 84%. This study suggests that imatinib is a promising treatment for patients with refractory fibrotic cGVHD.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2009-02-204156
    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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