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Simple Summary: Autologous hematopoietic cell transplantation (auto-HCT) can be used to salvage at least a proportion of plasma cell myeloma patients who relapse after a previous auto-HCT. It may, however, occur that there is either no or an insufficient stem cell dose in storage to proceed to transplantation. Remobilization to procure new cells is then required. There are very limited data in the literature concerning the efficacy of stem cell remobilization after previous auto-HCT. In our previous report, we showed that remobilization with cytarabine was associated with a lower risk of remobilization failure in comparison to etoposide or cyclophosphamide. In the current study, we analyze the efficacy and safety of different doses of cytarabine (800, 1600, and 2400 mg/m2), showing that all doses are efficacious but that the dose of 2400 mg/m2 is associated with the most toxicity. Therefore, lower doses of cytarabine seem to be preferable, with plerixafor rescue when needed. Salvage autologous hematopoietic cell transplantation (auto-HCT) may be used to treat relapse of plasma cell myeloma occurring after previous auto-HCT. When an insufficient number of hematopoietic stem cells have been stored from the initial harvest, remobilization is necessary. Here, we aimed to analyze the efficacy and safety of different doses of cytarabine (total 800 vs. 1600 vs. 2400 mg/m2) for remobilization. Sixty-five patients, 55% male, with a median age at remobilization 63 years, were included. Remobilization was performed with cytarabine_800 in 7, cytarabine_1600 in 36, and cytarabine_2400 in 22 patients. Plerixafor rescue was used in 25% of patients receiving cytarabine_1600 and 27% of those receiving cytarabine_2400. Patients administered cytarabine_800 were not rescued with plerixafor. Remobilization was successful in 80% of patients (57% cytarabine_800; 86% cytarabine_1600; 77% cytarabine_2400; p = 0.199). The yield of collected CD34+ cells did not differ between the different cytarabine doses (p = 0.495). Patients receiving cytarabine_2400 were at the highest risk of developing severe cytopenias, requiring blood product support, or having blood-stream infections. One patient died of septic shock after cytarabine_2400. In summary, remobilization with cytarabine is feasible in most patients. All doses of cytarabine allow for successful remobilization. Cytarabine_2400 is associated with higher toxicity; therefore, lower doses (800 or 1600 mg/m2) seem to be preferable. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: High‐dose chemotherapy with autologous hematopoietic stem cell transplantation (auto‐HSCT) improves the outcome of patients with multiple myeloma (MM). It seems that auto‐HSCT is also a feasible therapeutic option in MM dialysis‐dependent (MMDD) patients. However, to perform transplantation, a sufficient number of stem cells must be collected. Materials and Methods: Given that data on mobilization of auto‐HSC efficacy and safety in dialysis‐dependent patients are limited, we report data from all Polish Centers belonging to the Polish Myeloma Study Group. Twenty‐eight dialysis‐dependent MM‐patients were enrolled into this retrospective analysis. The study population comprised patients diagnosed between 2004 and 2015 in whom an attempt to collect auto‐HSC was made (68%: women, median age: 56). Patients received granulocyte‐colony stimulating factor (G‐CSF) alone or in combination with chemotherapy and autologous peripheral blood stem cells (auto‐PBSCs) were collected by leukapheresis. Results and Conclusions: The success rate in terms of obtaining sufficient number of CD34(+) cells/kg for an auto‐HSCT (≥2 × 106 cells/kg body weight) during the first mobilization attempt was 92% (26/28 patients), and for 2 auto‐HSCTs (≥4 × 106 cells/kg) – was 75% (21/28 patients). After the second mobilization attempt (undertaken in 8 patients), a sufficient number of CD34(+)/kg cells for an auto‐HSCT was obtained for all patients and the number of CD34(+)/kg collected cells was sufficient for 2 auto‐HSCT in 6 additional patients. Hematologic toxicity and infections were the most frequent complications. Higher doses of cytarabine (>1.6 g/m2) and cyclophosphamide (> 2 g/m2) should be avoided in MMDD patients due to toxicity. Further studies are needed to establish mobilization regimens, confirm their safety, and dosing in MMDD patients. [ABSTRACT FROM AUTHOR]

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Long-term outcomes following newer therapies for chronic lymphocytic leukemia (CLL) have rarely been reported. This article presents the results of the final analysis of the Polish Adult Leukemia Group PALG-CLL2 study performed 10 years from final patient enrollment. With the extended follow-up time, it was found that cladribine (2-CdA)-based combinations CMC (2-CdA, cyclophosphamide, mitoxantrone) and CC (2-CdA, cyclophosphamide) administered as first-line treatment of progressive CLL resulted in significantly longer progression-free survival, but similar overall survival compared to 2-CdA monotherapy. Furthermore, the risk of potentially fatal late adverse events including infections, autoimmune complications and, particularly, secondary neoplasms was comparable among patients treated with CMC, CC or 2-CdA. The results of our analysis support the importance of long-term outcome monitoring of randomized trials in CLL. [ABSTRACT FROM AUTHOR]

The paper summarizes the result of 21 follicular lymphoma patients subjected to radioimmunotherapy in PLRG centers. Ibritumomab (Zevalin) is the only radioimmonoconjugate currently available in Europe registered for treatment of follicular lymphoma relapsing or refractory after Rituximab. It combines the specificity of an anti CD20 monoclonal antibody with the power of beta emitting 90Y, being particularly efficient in a fibrosed, poorly vascularised lymph nodes. All 21 patients were heavily pretreated, after failing 2–6 lines of previous therapy. In the whole group median event free survival exceeded 15 month, and overall survival was not yet reached at 45 months of follow-up. Subgroup analysis and literature review are included, to identify patients which could merit most of RIT. Key words: radioimmunotherapy, Zevalin, Ibritumomab, follicular lymphoma [ABSTRACT FROM AUTHOR]

Introduction: R-CHOP immunochemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) is a standard first-line treatment for diffuse large B-cell lymphoma (DLBCL). None of the randomized trials have proved a statistically significant overall survival (OS) benefit in high-risk subgroups according to the International Prognostic Index (IPI)., Objectives: We retrospectively investigated the role of adding rituximab to anthracycline-based chemotherapy in patients with high-risk DLBCL according to the IPI., Patients and Methods: A total of 371 patients with high-risk DLBCL treated at 15 Polish hematology centers were retrospectively analyzed in 2 distinct age groups: older than 60 years and 60 years old or younger. Response rates, OS, and progression-free survival (PFS) were compared and analyzed., Results: The overall response rate (ORR) of high-risk DLBCL patients significantly improved in rituximabtreated patients compared with patients treated without rituximab (76.7% vs 95.6%; P <0.05). The R-CHOP immunochemotherapy prolonged survival in both older and younger subgroups. The 5-year projected OS and PFS in younger patients treated with rituximab vs chemotherapy alone were 42% vs 38% and 46% vs 27%, respectively (P <0.05), while the 5-year projected OS and PFS in older patients treated with rituximab vs chemotherapy alone were 82% vs 52% and 67% vs 45%, respectively (P <0.05)., Conclusions: With all the limitations of a retrospective analysis, the superiority of adding rituximab to CHOP combination chemotherapy has been clearly demonstrated regarding ORR, OS, and PFS in both age subgroups of patients with high-risk DLBCL.

The aim of the study was to investigate the bioavailability of a generic product of 100 mg and 400 mg imatinib film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence. The secondary objective of the study was to evaluate tolerability of both products. An open-label, randomized, crossover, two-period, single-dose, comparative study was conducted in 43 (Imatynib-Biofarm 100 mg film-coated tablet) and in 42 (Imatynib-Biofarm 400 mg film-coated tablet), brand name Imatenil, Caucasian healthy volunteers in fed conditions. A single oral dose administration of the test or reference product was separated by 14-day washout period. The imatinib and its metabolite N-desmethyl imatinib concentrations were determined using a validated LC MS/MS method. The results of the single-dose study in healthy volunteers indicated that the film-coated tablets of Imatynib-Biofarm 100 mg and 400 mg film-coated tablets manufactured by Biofarm Sp. z o.o. (test products) are bioequivalent to those of Glivec 100 mg and 400 mg film-coated tablets manufactured by Novartis Pharma GmbH (reference products). Both products in the two doses of imatinib were well tolerated.

Introduction: Infections caused with a variety of bacteria, fungi and viruses are still responsible for high level of mortality and morbidity in immunosupressed individuals. A case of fatal post-transplant reactivation with four herpesviruses in 49-year-old immunocompromised male with MDS-RAEB2, subjected to allogeneic haematopoietic stem cell transplantation was described., Methods: Full microbiological examination of was performed in different types of clinical samples (whole blood, stool). Sera specimens were tested for the presence of different viral DNA using the real-time PCR assays., Results and Conclusions: DNA of HSV-1, VZV, HHV-6 and EBV in serum samples was detected using molecular biology techniques. Viral level of HSV-1 and VZV was constantly increasing despite routine applied oral acyclovir therapy. These findings underline the value of real-time PCR technique used in current therapeutic procedures and for monitoring of antiviral therapy with nucleoside analogs. We found that real-time PCR is a useful tool in detection and monitoring of disseminated herpesviral infection, especially for the detection of low-copy viraemia in clinical specimens.

Sarcoidosis is a disease with a strongly variable clinical manifestation. It may be associated with various autoimmune diseases but hematological manifestations have rarely been observed. The prevalence of thrombocytopenia in patients with sarcoidosis has been estimated at 2%, about 1% of patients with thrombocytopenia have been diagnosed with sarcoidosis We present a case of sarcoidosis associated with primary immune thrombocytopenia of an abrupt and severe onset. Three potential patomechanisms of thrombocytopenia in sarcoidosis: 1) autoantibody related platelet destruction, 2) bone marrow involvement, and 3) hipersplenism are discussed.

Background: Autologous stem cell transplantation (autoSCT) is currently considered one of the standard approaches in the treatment of patients suffering from multiple myeloma and recurrent or relapsed lymphomas. Unfortunately, a significant proportion of those patients fail to mobilize minimum CD34+ cell dose to undergo this procedure. Here we present the strategy that allows to rescue the outcome of ongoing unsuccessful chemotherapy based mobilizations., Case Report: All five patients failed to release satisfactory number of CD34+ cells to peripheral blood after chemotherapy plus G-CSF-based mobilization regimen, despite raise in leukocytosis. In this situation, we decided to administer a booster of plerixafor, a specific CXCR4 receptor inhibitor. We observed rapid 2.6 to 16-fold increase of peripheral blood CD34+ cells number that allowed to start aphereses in all cases. Consequently, all five patients who would not otherwise collect required number of CD34+ cells, collected above 2.0×106 CD34+ cells/kg that allowed for hematopoietic stem cell transplantation., Conclusions: We would like to suggest that poor mobilizers could be rescued with the timely addition of plerixafor, thus they can avoid another procedure of stem cell mobilization.

Background: Ibritumomab is an (90)Yttrium ((90)Y) labelled radioimmunoconjugate registered to treat follicular lymphoma relapsing or refractory after Rituximab therapy. Combining the specificity of anti CD20 monoclonal antibodies with the efficacy of radiotherapy, it is particularly effective in patients with advanced stages of disease with generalized lymphadenopathy., Material and Methods: Twenty-one patients with follicular lymphoma, after failing 2-5 lines of previous treatment, were subjected to radioimmunotherapy in three Polish Lymphoma Research Group (PLRG) centres. Ibritumomab infusion was followed by 2 doses of Rituximab (250 mg/m(2) at day -7 and 0) to enhance its biodistribution. Radioimmunoconjugate was prepared in the Nuclear Medicine Departments of participating centres based on patient weight and full blood count results (14.8 MBq/kg, max 1200 MBq, reduced to 11.1 MBq/kg in cases with blood platelet 100,000-150,000 or leukocytes 1500-2000). 14.8 MBq/kg (0.4 mCi/kg) 100 thousand to 149 thousand/mm(3) platelets 11.1 MBq/kg (0.3 mCi/kg), Results: The primary endpoint of the study was the assessment of response rate and haematological toxicity. Objective responses were observed in all patients, with 10 partial and 12 complete regressions. Cytopenia, starting 3-4 weeks after radioimmunotherapy, reflected haematological toxicity - the only important side effect. Thrombocytopenia was more pronounced, with platelet counts of < 50,000/ul in every second patient. One patient developed myelodysplastic syndrome 21 months after the procedure. After the medium time of follow up over 2 years, 2 patients died. Median progression free survival (secondary study endpoint) was 15 months., Conclusions: Ibritumomab radioimmunotherapy is an efficient method of palliation treatment of heavily pre-treated follicular lymphoma patients, failing numerous previous treatment lines. Earlier application increases the number of complete responses and prolongs progression free survival.

Background: We previously published an early report of a randomized, multicenter trial on the efficacy and toxicity of cladribine (2-CdA) + prednisone (P) compared with chlorambucil (Chl) + P in previously untreated patients with progressive or symptomatic chronic lymphocytic leukemia. Here we present the final report of this study., Material/methods: Of 229 patients, 126 received 2-CdA+P and 103 Chl+P. Patients with no response or progression after three courses or who relapsed earlier than 12 months after completing one treatment were switched to the other. Patients who relapsed later were retreated with the same schedule as before., Results: Thirty-three patients were retreated with 2-CdA+P and 19 with Chl+P. Overall response (and complete response) rates were 35% (6%) and 47% (16%), respectively. In 50 patients initially treated with Chl+P and then with 2-CdA+P, complete response (CR) was achieved in 12 (24%) and overall response (OR) in 32 (64%). In 28 patients originally treated with 2-CdA+P and then with Chl+P, CR in 1 (3%, p=0.01) and OR in 6 (21%, p=0.003) were obtained. We found no statistically significant difference in overall survival time in patients treated initially with 2-CdA+P and Chl+P aged 60 years (4.63 and 5.27 years, respectively, p=0.45), 60-70 years (3.29 and 3.14 years, p=0.79), and >70 years (1.53 and 1.93 years, p=0.11)., Conclusions: 2-CdA+P is significantly more effective as a second-line treatment and re-treatment than Chl+P. However, we found a trend to longer survival in elderly patients treated with Chl+P.