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  • 1
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    A Phase I/II Study of Lenalidomide in Combination with Rituximab in Relapsed/Refractory Mantle Cell Lymphoma.
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 2719-2719
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 2719-2719
    Abstract: Abstract 2719 Poster Board II-695 Background: Rituximab directly targets CD20 positive lymphoma cells while lenalidomide targets the microenvironment. This combination was proven effective in vitro and in vivo in mantle cell lymphoma (Wu et al, Clin Cancer Res 2008; Zhang et al, Am J Hematol 2009). Clinically, lenalidomide (Habermann et al, Br J Haematol 2009) and rituximab have single-agent activity in mantle cell lymphoma (MCL) and may be an effective combination. The goal of our study was to determine the maximum tolerated dose (MTD) in phase 1 and evaluate the efficacy and safety of lenalidomide plus rituximab in patients with relapsed/refractory MCL in phase 2. Methods: Patients with relapsed/refractory MCL received lenalidomide on days 1–21 of every 28-day cycle, and rituximab (375 mg/m2) weekly during cycle 1. Dose escalation was used to determine the MTD with lenalidomide (10 mg, 15 mg, 20 mg, and 25 mg). Dose-limiting toxicity (DLT) was defined as grade 3 or 4 non-hematologic, or grade 4 hematologic adverse events in cycle 1. Phase 2 has reached targeted enrolment with 45 patients treated at MTD. Kaplan-Meier method was used to estimate progression free survival rate and response duration. Median time to event in months with 95% confidence interval was calculated. Of 45 patients treated at the MTD, the median age was 66 (46–85), 91% were males. All patients had received prior rituximab and were enrolled regardless of prior rituximab sensitivity or resistance. Results: The median follow-up time for the censored observations was 11.4 months. Two DLTs occurred at 25 mg in phase 1 (hypercalcemia, non-neutropenic fever); therefore, the MTD was 20 mg. The grade 3–4 non-hematologic events included elevated AST, elevated ALT, fatigue, myalgia, tremors, ataxia, cough, deep vein thrombosis, dyspnea, edema (facial), infection, neuropathy sensory, rash, and respiratory failure. Grade 3–4 hematologic adverse events included neutropenia (37 events), neutropenic fever (4 events), and thrombocytopenia (16 events). There were no responses in patients treated at 10 mg or 15 mg. Thirty six patients (36) were evaluable for response. Nine (9) patients are too early in their treatment and are not yet eligible for response evaluation. Among the 36 evaluable patients, 11 (31%) patients achieved CR, 8 (22%) patients achieved PR, 3 (8%) patients had minor response, 6 (17%) patients had stable disease and 8 (22%) patients had progressive mantle cell lymphoma. The overall response rate (CR + PR) was 53%. Seventy eight (78%) patients achieved stable disease or better and benefited from oral Lenalidomide plus 4 doses of rituximab. The median time to response was 2 months (2–8), and the median duration of response for the 19 patients with CR or PR was 18 months (95% CI: 10.6, NA) (range1–30 months). The median progression free survival for all patients on phase 2 was 14 months (95% CI: 9.8, NA) (ranging from 1–32 months). Conclusion: Oral lenalidomide plus rituximab resulted in durable responses in relapsed/refractory MCL with a favourable toxicity profile. Disclosures: Wang: Celgene: Honoraria, Research Funding. Hagemeister:Celgene Corporation: Consultancy. Samaniego:Celgene Corporation: Research Funding. Yi:Celgene Corporation: Research Funding. Shah:Celgene Corporation: Consultancy, Research Funding, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Elan: Consultancy; Millennium: Research Funding, Speakers Bureau. Bell:Celgene Corporation: Employment, Equity Ownership. Knight:Celgene Corporation: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees. Zeldis:Celgene: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.2719.2719
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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  • 2
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    Nonmyeloablative Allogeneic Transplantation (NMT) for Relapsed Follicular Lymphoma (FL): Continuous Complete Remission with Longer Follow-Up.
    American Society of Hematology ; 2007
    In:  Blood Vol. 110, No. 11 ( 2007-11-16), p. 485-485
    Details
    In: Blood, American Society of Hematology, Vol. 110, No. 11 ( 2007-11-16), p. 485-485
    Abstract: NMT carries the promise of long-term disease control in FL by graft-versus-lymphoma immunity. We investigated the long-term efficacy of this strategy. Between March 1999 and April 2005, 47 consecutive patients were enrolled, ranging in age from 33 to 68 years (median, 53 years). The time from diagnosis to transplantation ranged from 7 months to 24 years (median, 3 years). All patients had recurrent chemosensitive FL. Each patient had received 2 to 7 (median, 2) chemotherapy regimens. Eight patients (17%) had failed a prior autologous transplantation. At the time of transplantation, 29 patients (61%) were in PR, and 18 (31%) were in CR. The conditioning regimen consisted of fludarabine (30 mg/m2 daily for 3 days), cyclophosphamide (750 mg/m2 daily for 3 days) and rituximab (Khouri, Blood 2001). This was followed by an infusion of HLA-matched hematopoietic cells from related (n=45) or unelated donors (n=2). Tacrolimus and methotrexate were used for graft-versus-disease (GVHD) prophylaxis. All patients achieved CR after transplantation. The median time to achieve CR in patients who had evidence of active disease at study entry was 5.5 months. Two relapses occurred. One was observed at 18 months; this patient responded to DLI with a continuous CR at 24+ months. The other patient who developed a relapse, was found to be simultaneously in graft failure 20 months after his transplantation. That patient was treated with rituximab and is still in CR at his last follow-up 4 years later. Eighteen patients had PCR evidence of bcl-2 translocation in the bone marrow at study entry. There were a total of 100 bone marrow post-treatment PCR samples available for analysis. Ninety eight samples that are drawn at a median time of 45 months after transplantation (range 4 months to 72 months) showed a negative PCR result. Two samples from 2 different patients were PCR-positive early after transplant; they became PCR-negative 3 months later. With a median follow-up time of 56 months (range, 19–94 months), the estimated overall survival (OS) and current progression-free survival (CPFS) rates at 6 years were 85% (95% confidence interval [CI] , 71%–93%) and 83% (95% CI 69%–91%), respectively. The incidence of acute grade II–IV GVHD was 11% (95% CI, 31%–66%). The incidence of chronic extensive and limited GVHD, was 51% (95% CI, 44%–78%). Of the 28 patients who developed chronic GVHD, 20 (71%) had a de novo onset. The median time of onset of chronic GVHD was 262 days after transplantation, and the OS of patients with chronic GVHD was 89%, with a median follow-up time of 57 months (range, 19–94 months). Only five patients of the whole study group are still receiving immunosuppressive therapy at the time of their last follow-up. In conclusion, the longer follow-up of our study does provide further insight into long-term disease activity and regimen toxicity of NMT for FL, laying the groundwork for prospective comparative trials. We believe that the described results are a step forward toward finding a cure for this disease.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V110.11.485.485
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2007
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  • 3
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    Regulation of Fas-mediated Apoptosis in B-Cell Lymphomas by Nucleolin.
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 2406-2406
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 2406-2406
    Abstract: Abstract 2406 The death receptor Fas has a key role in mediating homeostasis, elimination of defective cells and more recently promotion of cancer. Many effective anti-cancer therapies depend on Fas-mediated apoptosis to eradicate tumor cells and ineffective Fas- apoptotic signaling is a basis for primary as well as acquired resistance to chemotherapy. We hypothesized that Fas is subjected to direct regulation and inhibition of Fas attained by cancer cells and may explain the emergence of chemoresistance. To screen for potential binding modulators of Fas, we analyzed lymphoma cells for Fas binding proteins. We first purified Fas associated proteins by using activating CH-11 antibody bound to intact BJAB cells. After immunoprecipitation, any remaining Fas, considered activation–resistant, was subjected to the second immunoprecipitation with Fas antibody B-10 followed by liquid chromatography and tandem mass spectroscopy. This purification scheme identified high scoring peptides derived from nucleolin, a nuclear protein known to be overexpressed in cancer. Nucleolin is selectively expressed on the surfaces of cancer cells and blood vessels undergoing angiogenesis. In a cell culture system, we confirmed binding of nucleolin to Fas and the presence of nucleolin-Fas complexes on the surface of lymphoma cells by surface biotin labeling. Using deletion mutants of nucleolin, we identified RNA binding domain 4 and glycine/arginine rich region to be required for the binding to Fas. BJAB cells with partially knockdown (KD) nucleolin showed significantly higher rates of apoptosis in response to stimulation with CH-11 and FasL when compared to nontarget KD controls. Importantly, the lower levels of nucleolin in knockdown cells did not affect total and surface Fas expression. Nucleolin present on the cell surface prevented binding of FasL and CH-11 to the receptor and thus provides a mechanism for blocking activation of Fas apoptosis. To examine the role of nucleon in vivo, we transfected mice with nucleolin-expressing plasmids using the hydrodynamic transfection method. The mice overexpressing nucleolin showed significantly higher survival rates than vector control transfected mice (P=.01) after a challenge with a lethal dose of agonistic anti-Fas antibody. We next examined the expression of nucleolin in human lymphomas. Cell lines derived from lymphomas of different histological types consistently expressed nucleolin protein. We found nucleolin expressed on the surface of cells in over 20 primary lymphoma isolates, whereas peripheral blood lymphocytes showed low or undetectable levels. Lymphoma tissue microarray staining showed a correlation between nucleolin and Ki-67 expression. Whether nucleolin expression also correlates with adverse clinical features in lymphoma is currently under evaluation. Taken together, we show here that the known cancer associated protein nucleolin is overexpressed on surface of lymphoma cells where it binds to Fas receptor and blocks Fas signaling and apoptosis. We expect that further analysis of nucleolin properties will reveal how Fas-nucleolin interaction can be targeted to enhance killing of cancer cells leading eventually to cell surface nucleolin targeting therapy. Disclosures: Fayad: Roche: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.2406.2406
    RVK:
    XA 33000
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    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
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  • 4
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    Phase II Trial Of Bortezomib In Combination With Fractionated Cyclophosphamide and Rituximab (BCR) For Relapsed/Refractory Mantle Cell Lymphoma (MCL)
    American Society of Hematology ; 2013
    In:  Blood Vol. 122, No. 21 ( 2013-11-15), p. 5122-5122
    Details
    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 5122-5122
    Abstract: MCL is incurable. Bortezomib has shown single agent activity of 33% in relapsed MCL. Pre-clinical published data shows additive/synergistic activity of BCR. Materials and methods   MCL pts  ages 18 through 85, with adequate organ function unless due to lymphoma, and without HIV-1 infection or any significant medical/mental condition, were treated under an IRB-approved study, consisting of Bortezomib  1.3 mg/m2 IV given on days 1, 4, 8, and 11 (dose on day 11 omitted early on study); fractionated cyclophosphamide 300 mg/m2 q 12 hrs days 1, 2, and 3, and rituximab 375 mg/m2 day 1. Cycles were repeated every 21 days for a total of 6 or less if a response was achieved and patient qualified for SCT. Results From  9/2009 to 8/2012, twenty-one patients were entered in the study. Their clinical characteristics are as follows: Overall response (OR)/CR rates:  71%/53%. One patient had stable disease and 4 patients progressed. With a Median follow-up of 31 months, the median TTP was 15.8 months and the median OS was 36.4 months. Toxicity was mainly hematologic. With 77 cycles given, grade 3 anemia was 5%, grade 3 / 4 neutropenia was 16%/9%, and grade 3 / 4 thrombocytopenia was 19%/8%. Early in the study, day 11 dose of bortezomib was omitted because of low counts by day 11 of cycle. Non-hematologic toxicity included grade 3 neutropenic fever (1%), and grade 3 fatigue (3%). No patient developed sensory neuropathy grade ¾. Conclusion Bortezomib can be safely combined with cyclophosphamide and rituximab and results in high rates of overall/complete responses in patients with relapsed/refractory MCL. Disclosures: Off Label Use: Gemcitabine, fludarabine and melphalan for transplant conditioning. Younes:Seattle Genetics, Inc.: Advisory/Scientific Board Membership Other, Honoraria, Research Funding. Pro:Seattle Genetics, Inc.: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Research Funding, Travel expenses Other.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V122.21.5122.5122
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
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  • 5
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    Favorable Results of Rituximab in Combination with CHOP in the Front-Line Treatment of Follicular Lymphoma Grade 3.
    American Society of Hematology ; 2006
    In:  Blood Vol. 108, No. 11 ( 2006-11-16), p. 2770-2770
    Details
    In: Blood, American Society of Hematology, Vol. 108, No. 11 ( 2006-11-16), p. 2770-2770
    Abstract: Background: Follicular lymphoma grade 3 has a natural history that is more akin to that of diffuse large B-cell lymphoma. The addition of rituximab to standard CHOP has resulted in improved response and survival in diffuse large B-cell lymphoma. Information about outcomes in follicular lymphoma grade 3 is lacking. Methods: A single institution retrospective review of patients with follicular grade 3 lymphoma evaluated at the UTMDACC from 1999 to 2004. Patients were located from the UTMDACC lymphoma database. All patients were initially treated with R-CHOP. Results: Forty-five patients were identified: 51% male, 47% ≥60 years, and 87% follicular grade 3b. The LDH was elevated in 24%, ECOG performance status was 〉 1 in 2%, and 〉 1 site of extranodal involvement was present in 10%. Stage distribution was 11% stage I, 11% stage II, 42% stage III, and 36% stage IV, bulky disease ( 〉 7cm) was present in 11%, and B symptoms occurred in 13%. Beta-2 microglobulin was elevated in 57% with values 〉 3 μg/dL in over 50%. IPI distribution was: 46% IPI Low, 38% LI, 11% IH, and 4% IPI High. Overall response rate was 100% with 96% complete responses. Relapse rate by IPI category was 24% for Low IPI, 18% for IPI LI, and 40% for IPI IH, and 100% for the two patients with High IPI. With median follow-up of 33 months, three year failure-free survival (FFS) is 73% (95% CI: 59 to 87%). One patient died (2%) with an overall survival (OS) at three years of 97% (95% CI: 93 to 100%). Conclusion: The addition of rituximab to CHOP provided a high response rate and excellent early survival in this group of mostly good prognosis patients. Relapses were still seen; longer follow-up is needed.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V108.11.2770.2770
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2006
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  • 6
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    Six Weekly Doses of Rituximab Plus ABVD for Newly Diagnosed Patients with Advanced Stage Classical Hodgkin Lymphoma: Depletion of Reactive B-Cells from the Microenvironment by Rituximab.
    American Society of Hematology ; 2005
    In:  Blood Vol. 106, No. 11 ( 2005-11-16), p. 1499-1499
    Details
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 1499-1499
    Abstract: The malignant Hodgkin and Reed-Sternberg (HRS) cells of Hodgkin lymphoma (HL) rarely survive outside their microenvironment, which is illustrated by the difficulty in establishing HRS-derived cell lines. Thus, we hypothesized that destroying the HL microenvironment may deprive HRS cells from critical survival factors leading to their death. The majority of the cells in this microenvironment are benign T and B lymphocytes. Both B and T cells have been reported to express growth and survival factors such as CD30 ligand, CD40 ligand, and RANK ligand that may support HRS cell survival. To determine the contribution of benign B-cells to the survival of HRS cells in vivo, we recently conducted a pilot study using rituximab alone in patients with relapsed classical HL. Rituximab produced an overall response rate of 23% in heavily pretreated patients with relapsed classical HL, presumably by depleting benign B cells from HL lesions. In this study, we evaluated the safety and efficacy of the novel combination of rituximab and ABVD (R-ABVD) chemotherapy in newly diagnosed patients with classical HL. Rituximab was given at 375 mg/m2 weekly for 6 weeks to rapidly deplete B lymphocytes, while ABVD was given at a standard dose and schedule. The first dose of rituximab was given concurrently with the first dose of ABVD (schedule A) or 3 weeks before the first dose of ABVD (schedule B). Patients with lesions larger than 5 cm received involved field radiation therapy at the end of R-ABVD. Patients were eligible if they were older than 16 years of age and had biopsy-confirmed classical HD irrespective of CD20 expression on RS cells, bidimensionally measurable disease, adequate bone marrow reserve (ANC & gt; 1,000/uL, Platelet & gt; 100,000/uL) and adequate cardiac and renal functions. They were excluded if they had HIV infection, or were pregnant women. To date 72 newly diagnosed pts are enrolled. Analysis of the first 52 pts is provided. Analysis of the entire 72 patients will be presented at the meeting. The median age was 30 years (range; 18–63 years). Patients had stage II (50%), stage III (31%), stage IV (19%) disease. Using the German prognostic score model, 32 patients (62%) had a score of 2 or higher. With a median follow up of 32 months, the estimated event-free survival (EFS) is 82% and overall survival 100%. EFS for patients with a prognostic score of 0–1 is 92%, score 0–2 is 86%, and score 3–5 is 73%. Treatment was reasonably well tolerated with the majority of toxicities being grade 1 and 2. One patient developed PCP pneumonia proven by bronchalveolar lavage. In two patients, fine needle aspiration of a peripheral lymph node was performed before the first and after the third dose of rituximab (schedule B-before starting ABVD). Rituximab induced complete depletion of B cells from HL node. We conclude that in patients with classical HL, the addition of 6 weekly doses of rituximab to standard dose and schedule of ABVD chemotherapy is effective in terms of remission rate and remission duration irrespective of CD20 expression on HRS cells. Furthermore, patients with prognostic score of 3 or higher had a 73% EFS suggesting that this strategy may improve treatment outcome in this patient population.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V106.11.1499.1499
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    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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  • 7
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    Results of Rituximab Plus ABVD in 65 Newly Diagnosed Patients with Classical Hodgkin Lymphoma: Improvement of Event Free Survival (EFS) in All International Prognostic Score (IPS) Groups.
    American Society of Hematology ; 2006
    In:  Blood Vol. 108, No. 11 ( 2006-11-16), p. 2742-2742
    Details
    In: Blood, American Society of Hematology, Vol. 108, No. 11 ( 2006-11-16), p. 2742-2742
    Abstract: The malignant Hodgkin and Reed-Sternberg (HRS) cells of classical Hodgkin lymphoma (HL) rarely survive outside their microenvironment, which is illustrated by the difficulty in establishing HRS-derived cell lines. Reactive B and T cells, monocytes, and eosinophils have been reported to express growth and survival factors such as CD30 ligand, CD40 ligand, RANK ligand, and BLyS that may support HRS cell survival. To examine the contribution of reactive B-cells to the survival of HRS cells in vivo, we hypothesized that depleting B-cells from the HL microenvironment by rituximab may deprive HRS cells from critical survival and resistance factors and thereby improving the efficacy of chemotherapy. To test this hypothesis, we evaluated the safety and efficacy of the novel combination of rituximab and ABVD (R-ABVD) chemotherapy in newly diagnosed patients with classical HL. Rituximab was given at 375 mg/m2 weekly for 6 weeks to rapidly deplete B lymphocytes, while ABVD was given at a standard dose and schedule. The first dose of rituximab was given concurrently with the first dose of ABVD (schedule A) or 3 weeks before the first dose of ABVD (schedule B). Patients with lesions larger than 5 cm received involved field radiation therapy at the end of R-ABVD. Patients were eligible if they were older than 16 years of age and had biopsy-confirmed classical HL irrespective of CD20 expression on HRS cells, bidimensionally measurable disease, adequate bone marrow reserve (ANC 〉 1,000/uL, Platelets 〉 100,000/uL) and adequate cardiac and renal functions. They were excluded if they had HIV infection, or were pregnant women. To date 70 newly diagnosed patients are enrolled, of whom 65 patients had at least 12 months of follow up and are evaluable for treatment response. The median age is 28 years (Range; 18–72 years). Patients had stage II (50%), stage III (31%), or stage IV (19%) disease. Using the IPS prognostic score model, 36 patients (55%) had a score of 2 or higher. With a median follow up of 32 months, the estimated event-free survival (EFS) for the entire group is 85% and the overall survival is 98%. EFS for patients with different IPS groups is shown in the table and is compared with the expected EFS for ABVD alone as reported by Hasenclever and Diehl (NEJM 1998). As shown, R-ABVD improved EFS in all IPS groups with the biggest impact seen in patients with IPS 〉 2. In two patients, fine needle aspiration of a peripheral lymph node was performed before the first and after the third dose of rituximab (schedule B-before starting ABVD). Rituximab induced complete depletion of CD20 and CD19 positive B cells from HL node. We conclude that in patients with classical HL, the addition of 6 weekly doses of rituximab to standard dose and schedule of ABVD chemotherapy is effective in terms of remission rate and remission duration irrespective of CD20 expression on HRS cells or IPS category. A randomized phase-II study is planned to evaluate this strategy in patients with high IPS score. IPS Score Group ABVD EFS (Hasenclever and Diehl) R-ABVD EFS (Current Study) 0–1 79% 95% 0–2 74% 87% 2 67% 76% 〉1 60% 76.5% 〉2 55% 77% 〉3 47% 71%
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V108.11.2742.2742
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2006
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  • 8
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    Blastoid Mantle Cell Lymphoma (MCL): 5-yr Failure-Free Survival (FFS) Rate of 50%, without Failures after 2.5 Years Following Treatment with Rituximab (R)-HyperCVAD Alternating with R-Methotrexate/Cytarabine (M/A).
    American Society of Hematology ; 2006
    In:  Blood Vol. 108, No. 11 ( 2006-11-16), p. 2749-2749
    Details
    In: Blood, American Society of Hematology, Vol. 108, No. 11 ( 2006-11-16), p. 2749-2749
    Abstract: Blastoid MCL has a very poor prognosis, with a median survival of 16–20 months after treatment with CHOP-like chemotherapy regimens. We recently described an intense regimen where R-HyperCVAD is alternated with R-M/A for 6–8 cycles, capable of achieving 87% complete remission (CR) rates and an overall 3-year FFS rate of 64% in a group of 97 patients with newly diagnosed aggressive MCL treated under an institutionally approved clinical trial from March 1999 to March 2001 (J Clin Oncol 23:7013–7023). Fourteen of these patients presented with the blastoid cytologic variant and the following clinical features were compared with those without a blastoid cytology: age 〉 65 years, beta 2 microglobulin ≥ 3 gm/dL, elevated serum lactic dehydrogenase (LDH), and high international prognostic score (IPI). Only serum LDH was significantly different, being higher for those with blastoid presentation (p = 0.03). Rates of complete remission were lower for blastoid when compared to non-blastoid cytology (79% vs 89%, respectively) but not statistically significant (p = 0.72). With a median follow up of 57 months, there is a plateau in the FFS curve for blastoid MCL as shown below. At 57 months the median overall survival has not been reached. Contrary to what we had expected, the improved outcome in this group of patients with blastoid cytology suggests a potential for long term remission after intense, non-myeloablative chemotherapy. Figure Figure
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V108.11.2749.2749
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2006
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  • 9
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    Phase II Study of Proteasome Inhibitor Bortezomib in Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
    American Society of Clinical Oncology (ASCO) ; 2005
    In:  Journal of Clinical Oncology Vol. 23, No. 4 ( 2005-02-01), p. 667-675
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 23, No. 4 ( 2005-02-01), p. 667-675
    Abstract: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Patients and Methods Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m 2 ) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles. Results Sixty patients with a median number of prior therapies of 3.5 (range, one to 12 therapies) were enrolled; 33 patients were in arm A and 27 were in arm B, including 12 diffuse large B-cell lymphomas, five follicular lymphomas (FL), three transformed FLs, four small lymphocytic lymphomas (SLL), two Waldenström's macroglobulinemias (WM), and one marginal zone lymphoma. In arm A, 12 of 29 assessable patients responded (six complete responses [CR] and six partial responses [PR] ) for an overall response rate (ORR) of 41% (95% CI, 24% to 61%), and a median time to progression not reached yet, with a median follow-up of 9.3 months (range, 1.7 to 24 months). In arm B, four of 21 assessable patients responded (one SLL patient had a CR, one FL patient had a CR unconfirmed, one diffuse large B-cell lymphoma patient had a PR, and one WM patient had a PR) for an ORR of 19% (95% CI, 5% to 42%). Grade 3 toxicity included thrombocytopenia (47%), gastrointestinal (20%), fatigue (13%), neutropenia (10%), and peripheral neuropathy (5%). Grade 4 toxicity occurred in nine patients (15%), and three deaths from progression of disease occurred within 30 days of withdrawal from study. Conclusion Bortezomib showed promising activity in relapsed mantle-cell lymphoma and encouraging results in other B-cell lymphomas. Future studies will explore bortezomib in combination with other cytotoxic or biologic agents.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2005.03.108
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2005
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    Phase II Study of Denileukin Diftitox for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
    American Society of Clinical Oncology (ASCO) ; 2004
    In:  Journal of Clinical Oncology Vol. 22, No. 20 ( 2004-10-15), p. 4095-4102
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 22, No. 20 ( 2004-10-15), p. 4095-4102
    Abstract: Denileukin diftitox is a fusion protein combining diphtheria toxin and interleukin-2 (IL-2) that targets tumor cells expressing the IL-2 receptor. Its efficacy has been shown in CD25+ cutaneous T-cell lymphoma, but not in B-cell non-Hodgkin's lymphoma (NHL). A phase II study was performed to evaluate the efficacy and tolerability of denileukin diftitox for relapsed or refractory B-cell NHL. Patients and Methods Patients with relapsed or refractory B-cell NHL were eligible. Tumor CD25 expression was determined by immunohistochemistry or flow cytometry. Denileukin diftitox was administered intravenously at a dose of 18 μg/kg once daily for 5 days every 3 weeks, up to eight cycles. Results Of the 45 patients assessable for response, 32 (71%) were refractory to the last chemotherapy treatment, and all were previously treated with rituximab. Three complete responses (6.7%) and eight partial responses (17.8%) were observed, for an overall response rate of 24.5%. Nine patients (20%) had stable disease. Objective response rates were similar in CD25+ (22%) and CD25− histologies (29%), as were stable disease rates (22% and 18%, respectively). For responding patients, the median time to treatment failure was 7 months, with a median follow-up in survivors of 18 months (range, 9 to 28 months), and the projected progression-free survival at 20 months was 24% (95% CI, 0% to 60%). Most toxicities were low-grade and transient. Conclusion Denileukin diftitox seems to be effective in relapsed or refractory, CD25+ and CD25− B-cell NHL and is well-tolerated at the dosage evaluated. Evaluation of denileukin diftitox in combination with other agents may be warranted.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2004.03.071
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2004
    detail.hit.zdb_id: 2005181-5
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