5 results on '"Haenel, Mathias"'
Search Results
2. Cyclophosphamide-based stem cell mobilization in relapsed multiple myeloma patients: A subgroup analysis from the phase III trial ReLApsE.
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Baertsch MA, Schlenzka J, Lisenko K, Krzykalla J, Becker N, Weisel K, Noppeney R, Martin H, Lindemann HW, Haenel M, Nogai A, Scheid C, Salwender H, Fenk R, Graeven U, Reimer P, Schmidt-Hieber M, Goerner M, Schmidt-Wolf IGH, Klein S, Ho AD, Goldschmidt H, and Wuchter P
- Subjects
- Adult, Aged, Cyclophosphamide adverse effects, Female, Granulocyte Colony-Stimulating Factor administration & dosage, Granulocyte Colony-Stimulating Factor adverse effects, Humans, Male, Middle Aged, Peripheral Blood Stem Cells cytology, Peripheral Blood Stem Cells drug effects, Peripheral Blood Stem Cells metabolism, Recurrence, Time-to-Treatment, Transplantation, Autologous, Treatment Outcome, Cyclophosphamide administration & dosage, Hematopoietic Stem Cell Mobilization methods, Hematopoietic Stem Cell Transplantation adverse effects, Hematopoietic Stem Cell Transplantation methods, Multiple Myeloma pathology, Multiple Myeloma therapy
- Abstract
Objective: Analysis of the efficiency and toxicity of cyclophosphamide-based stem cell mobilization in patients with relapsed multiple myeloma (RMM)., Methods: Peripheral blood stem cells (PBSCs) were mobilized with high dose cyclophosphamide (2 g/m
2 daily on days 1 and 2) and G-CSF plus pre-emptive/rescue plerixafor in RMM patients (first to third relapse) treated within the ReLApsE trial of the German-Speaking Myeloma Multicenter Group (GMMG)., Results: Mobilization was initiated with high-dose cyclophosphamide (HD-CY) and G-CSF in 30 patients. Fifteen patients received additional pre-emptive/rescue administration of plerixafor. Stem cell collection was successful (≥2×106 CD34+ cells per kg bw) in 77% (23/30 patients). Patients with prior high-dose melphalan collected a significantly lower median total number of PBSCs than patients without prior high-dose melphalan (3.3×106 vs 17×106 CD34+ cells/kg bw). Toxicity of HD-CY was frequent with 12 serious adverse events (SAE) in 37% of patients (11/30 patients). Infections accounted for the majority of SAE reports. In two patients, SAEs were lethal (septic shock)., Conclusions: These data proof feasibility of PBSC collection at relapse but emphasize the importance of collection and storage of additional PBSC transplants during first-line treatment when mobilization is more efficient and less toxic., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)- Published
- 2017
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3. Cystic transformation of focal lesions after therapy is associated with remission but adverse outcome in myeloma.
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Merz, Maximilian, Hielscher, Thomas, Mai, Elias Karl, Seckinger, Anja, Hose, Dirk, Jauch, Anna, Sauer, Sandra, Luntz, Steffen, Bertsch, Uta, Raab, Marc S., Neben, Kai, Salwender, Hans, Blau, Igor W., Lindemann, Hans-Walter, Dürig, Jan, Scheid, Christof, Haenel, Mathias, Weisel, Katja, Weber, Tim, and Delorme, Stefan
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MULTIPLE myeloma treatment ,MULTIPLE myeloma diagnosis ,CYCLOPHOSPHAMIDE ,MELPHALAN ,DRUG dosage - Published
- 2019
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4. Four versus six cycles of CHOP chemotherapy in combination with six applications of rituximab in patients with aggressive B-cell lymphoma with favourable prognosis (FLYER): a randomised, phase 3, non-inferiority trial.
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Poeschel, Viola, Held, Gerhard, Ziepert, Marita, Witzens-Harig, Mathias, Holte, Harald, Thurner, Lorenz, Borchmann, Peter, Viardot, Andreas, Soekler, Martin, Keller, Ulrich, Schmidt, Christian, Truemper, Lorenz, Mahlberg, Rolf, Marks, Reinhard, Hoeffkes, Heinz-Gert, Metzner, Bernd, Dierlamm, Judith, Frickhofen, Norbert, Haenel, Mathias, and Neubauer, Andreas
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COMBINATION drug therapy , *BODY surface area , *LACTATE dehydrogenase , *PROGRESSION-free survival , *LYMPHOMAS , *THERAPEUTIC use of antineoplastic agents , *ANTINEOPLASTIC agents , *B cell lymphoma , *COMPARATIVE studies , *DOXORUBICIN , *DRUG administration , *INTRAVENOUS therapy , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *ORAL drug administration , *PREDNISONE , *RESEARCH , *SURVIVAL analysis (Biometry) , *TUMOR classification , *VINCRISTINE , *EVALUATION research , *RANDOMIZED controlled trials , *TREATMENT effectiveness , *CYCLOPHOSPHAMIDE - Abstract
Background: Six cycles of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) are the standard treatment for aggressive B-cell non-Hodgkin lymphoma. In the FLYER trial, we assessed whether four cycles of CHOP plus six applications of rituximab are non-inferior to six cycles of R-CHOP in a population of patients with B-cell non-Hodgkin lymphoma with favourable prognosis.Methods: This two-arm, open-label, international, multicentre, prospective, randomised phase 3 non-inferiority trial was done at 138 clinical sites in Denmark, Israel, Italy, Norway, and Germany. We enrolled patients aged 18-60 years, with stage I-II disease, normal serum lactate dehydrogenase concentration, ECOG performance status 0-1, and without bulky disease (maximal tumour diameter <7·5 cm). Randomisation was computer-based and done centrally in a 1:1 ratio using the Pocock minimisation algorithm after stratification for centres, stage (I vs II), and extralymphatic sites (no vs yes). Patients were assigned to receive either six cycles of R-CHOP or four cycles of R-CHOP plus two doses of rituximab. CHOP comprised cyclophosphamide (750 mg/m2), doxorubicin (50 mg/m2), and vincristine (1·4 mg/m2, with a maximum total dose of 2 mg), all administered intravenously on day 1, plus oral prednisone or prednisolone at the discretion of the investigator (100 mg) administered on days 1-5. Rituximab was given at a dose of 375 mg/m2 of body surface area. Cycles were repeated every 21 days. No radiotherapy was planned except for testicular lymphoma treatment. The primary endpoint was progression-free survival after 3 years. The primary analysis was done in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of assigned treatment. A non-inferiority margin of -5·5% was chosen. The trial, which is completed, was prospectively registered at ClinicalTrials.gov, NCT00278421.Findings: Between Dec 2, 2005, and Oct 7, 2016, 592 patients were enrolled, of whom 295 patients were randomly assigned to receive six cycles of R-CHOP and 297 were assigned to receive four cycles of R-CHOP plus two doses of rituximab. Four patients in the four-cycles group withdrew informed consent before the start of treatment, so 588 patients were included in the intention-to-treat analysis. After a median follow-up of 66 months (IQR 42-100), 3-year progression-free survival of patients who had four cycles of R-CHOP plus two doses of rituximab was 96% (95% CI 94-99), which was 3% better (lower limit of the one-sided 95% CI for the difference was 0%) than six cycles of R-CHOP, demonstrating the non-inferiority of the four-cycles regimen. 294 haematological and 1036 non-haematological adverse events were documented in the four-cycles group compared with 426 haematological and 1280 non-haematological adverse events in the six-cycles group. Two patients, both in the six-cycles group, died during study therapy.Interpretation: In young patients with aggressive B-cell non-Hodgkin lymphoma and favourable prognosis, four cycles of R-CHOP is non-inferior to six cycles of R-CHOP, with relevant reduction of toxic effects. Thus, chemotherapy can be reduced without compromising outcomes in this population.Funding: Deutsche Krebshilfe. [ABSTRACT FROM AUTHOR]- Published
- 2019
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5. Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002-1)
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Schmitz, Norbert, Nickelsen, Maike, Ziepert, Marita, Haenel, Mathias, Borchmann, Peter, Schmidt, Christian, Viardot, Andreas, Bentz, Martin, Peter, Norma, Ehninger, Gerhard, Doelken, Gottfried, Ruebe, Christian, Truemper, Lorenz, Rosenwald, Andreas, Pfreundschuh, Michael, Loeffler, Markus, and Glass, Bertram
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CANCER chemotherapy , *RITUXIMAB , *B cell lymphoma , *LYMPHOMA risk factors , *CELL transplantation , *HEMATOPOIETIC stem cells , *RANDOMIZED controlled trials , *CYCLOPHOSPHAMIDE , *PATIENTS - Abstract
Summary: Background: High-dose therapy (HDT) followed by transplantation of autologous haemopoietic stem cells is frequently done as part of first-line therapy in young patients with high-risk aggressive B-cell lymphoma. We investigated whether HDT with cytotoxic agents identical to those used for conventional therapy followed by autologous stem-cell transplantation (ASCT) improved survival outcome compared with conventional chemotherapy when rituximab was added to both modalities. Methods: We did an open-label, randomised trial comparing conventional chemotherapy (cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone) and rituximab (R-CHOEP-14) with dose-escalated sequential HDT and rituximab (R-MegaCHOEP) followed by repetitive ASCT in high-risk (age-adjusted International Prognostic Index [IPI] 2 or 3) patients aged 18–60 years with aggressive B-cell lymphoma. Eligible patients received radiotherapy for bulky, extranodal disease, or both. Randomisation (1:1) used the Pocock minimisation algorithm; patients were stratified by age-adjusted IPI factors, bulky disease, and centre. The primary endpoint was event-free survival. All analyses were done on the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00129090. Findings: 136 patients were randomly assigned to R-CHOEP-14 and 139 to R-MegaCHOEP. 130 patients in the R-CHOEP-14 group and 132 in the R-MegaCHOEP group were included in the intention-to-treat population. After a median of 42 months (IQR 29–59), 3-year event-free survival was 69·5% (95% CI 61·3–77·7) in the R-CHOEP-14 group and 61·4% (52·8–70·0) in the R-MegaCHOEP group (p=0·14; hazard ratio 1·3, 95% CI 0·9–2·0). All 128 evaluable patients treated with R-MegaCHOEP had grade 4 leucopenia, as did 48 (58·5%) of 82 patients with documented blood counts in the R-CHOEP-14 group. All 128 evaluable patients in the R-MegaCHOEP group had grade 3–4 thrombocytopenia, as did 26 (33·8%) of 77 patients in the R-CHOEP-14 group with documented blood counts. The most important non-haematological grade 3 or 4 adverse event was infection, which occurred in 96 (75·0%) of 128 patients treated with R-MegaCHOEP and in 40 (31·3%) of 128 patients treated with R-CHOEP-14. Interpretation: In young patients with high-risk aggressive B-cell lymphoma, R-MegaCHOEP was not superior to conventional R-CHOEP therapy and was associated with significantly more toxic effects. R-CHOEP-14 with or without radiotherapy remains a treatment option for these patients, with encouraging efficacy. Funding: Deutsche Krebshilfe. [Copyright &y& Elsevier]
- Published
- 2012
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