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1. Second primary malignancies in treated and untreated patients with chronic lymphocytic leukemia

Author

Fürstenau, Moritz, primary, Giza, Adam, additional, Stumpf, Thomas, additional, Robrecht, Sandra, additional, Maurer, Christian, additional, Linde, Hartmut, additional, Jacobasch, Lutz, additional, Dörfel, Steffen, additional, Aldaoud, Ali, additional, Tresckow, Julia, additional, Koenigsmann, Michael, additional, Gaska, Tobias, additional, Kaiser, Ulrich, additional, Harich, Hanns‐Detlev, additional, Fischer, Kirsten, additional, Eichhorst, Barbara, additional, Hallek, Michael, additional, and Fink, Anna‐Maria, additional

Published
2021
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2. Second primary malignancies in treated and untreated patients with chronic lymphocytic leukemia

Author

Fuerstenau, Moritz, Giza, Adam, Stumpf, Thomas, Robrecht, Sandra, Maurer, Christian, Linde, Hartmut, Jacobasch, Lutz, Doerfel, Steffen, Aldaoud, Ali, von Tresckow, Julia, Koenigsmann, Michael, Gaska, Tobias, Kaiser, Ulrich, Harich, Hanns-Detlev, Fischer, Kirsten, Eichhorst, Barbara, Hallek, Michael, Fink, Anna-Maria, Fuerstenau, Moritz, Giza, Adam, Stumpf, Thomas, Robrecht, Sandra, Maurer, Christian, Linde, Hartmut, Jacobasch, Lutz, Doerfel, Steffen, Aldaoud, Ali, von Tresckow, Julia, Koenigsmann, Michael, Gaska, Tobias, Kaiser, Ulrich, Harich, Hanns-Detlev, Fischer, Kirsten, Eichhorst, Barbara, Hallek, Michael, and Fink, Anna-Maria

Published
2021

3. Long-term efficacy and safety of maintenance with lenalidomide in patients with chronic lymphocytic leukaemia and a high risk of progression after first-line immunochemotherapy

Author

Fink, Anna-Maria, Robrecht, Sandra, Bahlo, Jasmin, Fuerstenau, Moritz, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Kater, Arnon, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Rittgen, Matthias, Boettcher, Sebastian, Eichhorst, Barbara, Hallek, Michael, Fink, Anna-Maria, Robrecht, Sandra, Bahlo, Jasmin, Fuerstenau, Moritz, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Kater, Arnon, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Rittgen, Matthias, Boettcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Published
2020

5. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network

Author

Dreyling, Martin, Lenz, Georg, Hoster, Eva, Van Hoof, Achiel, Gisselbrecht, Christian, Schmits, Rudolf, Metzner, Bernd, Truemper, Lorenz, Reiser, Marcel, Steinhauer, Hjalmar, Boiron, Jean-Michel, Boogaerts, Marc A., Aldaoud, Ali, Silingardi, Vittorio, Kluin-Nelemans, Hanneke C., Hasford, Joerg, Parwaresch, Reza, Unterhalt, Michael, and Hiddemann, Wolfgang

Published
2005
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6. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study

Author

Fink, Anna Maria, Bahlo, Jasmin, Robrecht, Sandra, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens-Martin, Noesslinger, Thomas, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P., Dohner, Hartmut, Kneba, Michael, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Ritgen, Matthias, Boettcher, Sebastian, Eichhorst, Barbara, Hallek, Michael, Fink, Anna Maria, Bahlo, Jasmin, Robrecht, Sandra, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens-Martin, Noesslinger, Thomas, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P., Dohner, Hartmut, Kneba, Michael, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Ritgen, Matthias, Boettcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Abstract

Background The combined use of genetic markers and detectable minimal residual disease identifies patients with chronic lymphocytic leukaemia with poor outcome after first-line chemoimmunotherapy. We aimed to assess lenalidomide maintenance therapy in these high-risk patients. Methods In this randomised, double-blind, phase 3 study (CLLM1; CLL Maintenance 1 of the German CLL Study Group), patients older than 18 years and diagnosed with immunophenotypically confirmed chronic lymphocytic leukaemia with active disease, who responded to chemoimmunotherapy 2-5 months after completion of first-line therapy and who were assessed as having a high risk for an early progression with at least a partial response after four or more cycles of first-line chemoimmunotherapy, were eligible if they had high minimal residual disease levels or intermediate levels combined with an unmutated IGHV gene status or TP53 alterations. Patients were randomly assigned (2: 1) to receive either lenalidomide (5 mg) or placebo. Randomisation was done with a fixed block size of three, and was stratified according to the minimal residual disease level achieved after first-line therapy. Maintenance was started with 5 mg daily, and was escalated to the target dose of 15 mg. If tolerated, medication was administered until disease progression. The primary endpoint was progression-free survival according to an independent review. The pre-planned interim analysis done by intention to treat was done after 20% of the calculated progression-free survival events. This study is registered with ClinicalTrials.gov, number NCT01556776; treatment in the lenalidomide group is still ongoing. Findings Between July 5, 2012, and March 15, 2016, 468 previously untreated patients with chronic lymphocytic leukaemia were screened for the study; 379 (81%) were not eligible. Recruitment was closed prematurely due to poor accrual after 89 of 200 planned patients were randomly assigned: 60 (67%) enrolled patients were assigned t

Published
2017

7. Lenalidomide Maintenance after Front Line Therapy Substantially Prolongs Progression Free Survival in High Risk CLL: Interim Results of a Phase 3 Study (CLL M1 study of the German CLL Study Group)

Author

Fink, Anna Maria, primary, Bahlo, Jasmin, additional, Sandra, Robrecht, additional, Al-Sawaf, Othman, additional, Aldaoud, Ali, additional, Hebart, Holger, additional, Jentsch-Ulrich, Kathleen, additional, Doerfel, Steffen, additional, Fischer, Kirsten, additional, Wendtner, Clemens Martin, additional, Noesslinger, Thomas, additional, Ghia, Paolo, additional, Bosch, Francesc, additional, Kater, Arnon P., additional, Kreuzer, Karl-Anton, additional, Dohner, Hartmut, additional, Kneba, Michael, additional, Stilgenbauer, Stephan, additional, Boettcher, Sebastian, additional, Eichhorst, Barbara, additional, and Hallek, Michael, additional

Published
2016
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8. Lenalidomide Maintenance after Front Line Therapy Substantially Prolongs Progression Free Survival in High Risk CLL: Interim Results of a Phase 3 Study (CLL M1 study of the German CLL Study Group)

Author

Fink, Anna Maria, Bahlo, Jasmin, Sandra, Robrecht, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ulrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P., Kreuzer, Karl-Anton, Dohner, Hartmut, Kneba, Michael, Stilgenbauer, Stephan, Boettcher, Sebastian, Eichhorst, Barbara, Hallek, Michael, Fink, Anna Maria, Bahlo, Jasmin, Sandra, Robrecht, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ulrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P., Kreuzer, Karl-Anton, Dohner, Hartmut, Kneba, Michael, Stilgenbauer, Stephan, Boettcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Published
2016

10. Bendamustine Induces Higher Remission Rates, Prolongs Progression Free Survival as Well as Time to Next Treatment, and Improves Overall Survival for Patients In Complete Remission without Compromising Quality of Life When Compared to Chlorambucil In First Line Treatment of Chronic Lymphocytic Leukemia

Author

Knauf, Wolfgang Ulrich, primary, Lissitchkov, Toshko, additional, Aldaoud, Ali, additional, Liberati, Anna Marina, additional, Loscertales, Javier, additional, Herbrecht, Raoul, additional, Juliusson, Gunnar, additional, Postner, Gerhard, additional, Gercheva, Liana, additional, Goranov, Stefan, additional, Becker, Martin, additional, Fricke, Hans-Joerg, additional, Huguet, Françoise, additional, Del Guidice, Ilaria, additional, Klein, Peter, additional, Merkle, Karlheinz, additional, and Montillo, Marco, additional

Published
2010
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11. Bendamustine in the Treatment of Chronic Lymphocytic Leukemia -Consistent Superiority Over Chlorambucil in Elderly Patients and Across Clinically Defined Risk Groups.

Author

Knauf, Wolfgang Ulrich, primary, Lissitchkov, Toshko, additional, Aldaoud, Ali, additional, Liberati, Anna, additional, Loscertales, Javier, additional, Herbrecht, Raoul, additional, Juliusson, Gunnar, additional, Postner, Gerhard, additional, Gercheva, Liana, additional, Goranov, Stefan, additional, Becker, Martin, additional, Fricke, Hans-Joerg, additional, Huguet, Francoise, additional, Del Giudice, Ilaria, additional, Klein, Peter, additional, Merkle, Karlheinz, additional, and Montillo, Marco, additional

Published
2009
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12. Rituximab in Combination with CHOP in Patients with Follicular Lymphoma: Analysis of Treatment Outcome of 552 Patients Treated in a Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG) after a Follow up of 58 Months

Author

Buske, Christian, primary, Hoster, Eva, primary, Dreyling, Martin, primary, Forstpointner, Roswitha, primary, Kneba, Michael, primary, Schmitz, Norbert, primary, Schmits, Rudolf, primary, Metzner, Bernd, primary, Reiser, Marcel, primary, Lengfelder, Eva, primary, Woermann, Bernhard J, primary, Harder, Harriet, primary, Hegewisch-Becker, Susanna, primary, Berdel, Wolfgang E., primary, Hess, Georg, primary, Eimermacher, Hartmut, primary, Aldaoud, Ali, primary, Planker, Manfred, primary, Unterhalt, Michael, primary, and Hiddemann, Wolfgang, primary

Published
2008
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13. Bendamustine Versus Chlorambucil as First-Line Treatment in B Cell Chronic Lymphocytic Leukemia: An Updated Analysis from An International Phase III Study.

Author

Knauf, Wolfgang Ulrich, primary, Lissitchkov, Toshko, primary, Aldaoud, Ali, primary, Liberati, Anna, primary, Loscertales, Javier, primary, Herbrecht, Roul, primary, Juliusson, Gunnar, primary, Postner, Gerhard, primary, Gercheva, Liana, primary, Goranov, Stefan, primary, Becker, Martin, primary, Hoeffken, Klaus, primary, Huguet, Francoise, primary, Foa, Robert, primary, Merkle, Karlheinz, primary, and Montillo, Marco, primary

Published
2008
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14. The Addition of Rituximab to First-Line Chemotherapy (R-CHOP) Results in Superior Response Rates, Time to Treatment Failure and Response Duration in Patients with Advanced Stage Mantle Cell Lymphoma: Long Term Results of a Randomized GLSG Trial

Author

Hoster, Eva, primary, Unterhalt, Michael, primary, Wörmann, Bernhard, primary, Dührsen, Ulrich, primary, Metzner, Bernd, primary, Eimermacher, Hartmut, primary, Neubauer, Andreas, primary, Wandt, Hannes, primary, Steinhauer, Hjalmar, primary, Martin, Sonja, primary, Heidemann, Else, primary, Aldaoud, Ali, primary, Hiddemann, Wolfgang, primary, and Dreyling, Martin, primary

Published
2008
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16. High Anti-Lymphoma Activity of Bendamustine/Mitoxantrone/Rituximab (BMR) in Rituximab Pretreated Relapsed or Refractory Indolent Lymphomas. A Multicentre Phase II Study of the German Low Grade Lymphoma Study Group (GLSG).

Author

Weide, Rudolf, primary, Hess, Georg, additional, Koeppler, Hubert, additional, Heymanns, Jochen, additional, Thomalla, Joerg, additional, Aldaoud, Ali, additional, Losem, Christoph, additional, Schmitz, Stefan, additional, Haak, Ursula, additional, Huber, Christoph, additional, Unterhalt, Michael, additional, Hiddemann, Wolfgang, additional, and Dreyling, Martin, additional

Published
2006
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17. The Addition of Rituximab to Combination Chemotherapy with CHOP Has a Long Lasting Impact on Subsequent Treatment in Remission in Follicular Lymhoma but Not in Mantle Cell Lymphoma: Results of Two Prospective Randomized Studies of the German Low Grade Lymphoma Study Group (GLSG).

Author

Hiddemann, Wolfgang, primary, Forstpointner, Roswitha, additional, Kneba, Michael, additional, Schmitz, Norbert, additional, Schmits, Rudolf, additional, Metzner, Bernd, additional, Reiser, Marcel, additional, Lengfelder, Eva, additional, Woermann, Bernhard, additional, Harder, Hariett, additional, Hegewisch-Becker, Susanna, additional, Berdel, Wolfgang, additional, Hess, Georg, additional, Eimermacher, Hartmut, additional, Aldaoud, Ali, additional, Planker, Manfred, additional, Parwaresch, Reza, additional, Dreyling, Martin, additional, and Unterhalt, Michael, additional

Published
2004
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18. Bendamustine/Mitoxantrone/Rituximab (BMR): A Very Effective and Well Tolerated Immuno-Chemotherapy for Relapsed and Refractory Indolent Lymphomas - Results of a Multicentre Phase-II-Study of the German Low Grade Lymphoma Study Group (GLSG).

Author

Weide, Rudolf, primary, Koeppler, Hubert, primary, Heymanns, Jochen, primary, Thomalla, Joerg, primary, Hess, Georg, primary, Gamm, Heinhold, primary, Aldaoud, Ali, primary, Schmitz, Stephan, primary, Haak, Ursula, primary, Plewe, Dirk, primary, Burkhard, Oswald, primary, Gaede, Bernd, primary, Hinrichs, Fokke, primary, Pflueger, Karl-Heinz, primary, Dreyling, Martin, primary, Unterhalt, Michael, primary, and Hiddemann, Wolfgang, primary

Published
2004
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20. Early Consolidation with Myeloablative Radiochemotherapy Followed by Autologous Stem Cell Transplantation in First Remission Significantly Prolongs Progression-Free Survival in Mantle Cell Lymphoma - Long Term Follow up of a Prospective Randomized Trial of the European MCL Network.

Author

Dreyling, Martin H., primary, Lenz, Georg, additional, Schiegnitz, Eva, additional, van Hoof, Achiel, additional, Gisselbrecht, Christian, additional, Pfreundschuh, Michael, additional, Metzner, Bernd, additional, Truemper, Lorenz H., additional, Reiser, Marcel, additional, Steinhauer, Hjalmar B., additional, Boiron, Jean-Michel, additional, Boogaerts, Marc A., additional, Aldaoud, Ali, additional, Silingardi, Vittorio, additional, Kluin-Nelemans, Hanneke C., additional, Hasford, Joerg, additional, Parwaresch, Reza, additional, Michael, Unterhalt, additional, and Wolfgang, Hiddemann, additional

Published
2004
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21. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group

Author

Hiddemann, Wolfgang, Kneba, Michael, Dreyling, Martin, Schmitz, Norbert, Lengfelder, Eva, Schmits, Rudolf, Reiser, Marcel, Metzner, Bernd, Harder, Harriet, Hegewisch-Becker, Susanna, Fischer, Thomas, Kropff, Martin, Reis, Hans-Edgar, Freund, Mathias, Wörmann, Bernhard, Fuchs, Roland, Planker, Manfred, Schimke, Jörg, Eimermacher, Hartmut, Trümper, Lorenz, Aldaoud, Ali, Parwaresch, Reza, and Unterhalt, Michael

Abstract

Phase 2 studies suggest that the monoclonal antibody rituximab may improve the prognosis of patients with follicular lymphoma (FL) when it is added to chemotherapy. In the current study, 428 patients with untreated, advanced-stage FL were randomly assigned for therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) alone (n = 205) or CHOP combined with rituximab (R-CHOP) (n = 223). R-CHOP reduced the relative risk for treatment failure by 60% and significantly prolonged the time to treatment failure (P< .001). In addition, a significantly higher overall response rate (96% vs 90%; P= .011) and a prolonged duration of remission (P= .001) were achieved. In spite of a relatively short observation time, these beneficial effects even translated to superior overall survival (P= .016), with 6 deaths in the R-CHOP group compared with 17 deaths in the CHOP group within the first 3 years. The predominant treatment-related adverse effect was myelosuppression. Severe granulocytopenia was more frequently observed after R-CHOP (63% vs 53%; P= .01). However, severe infections were rare and of similar frequency after R-CHOP and CHOP (5% and 7%). Hence, adding rituximab to CHOP significantly improves the outcome for patients with previously untreated advanced-stage FL and does not induce major adverse effects.

Published
2005
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22. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study

Author

Michael Kneba, Holger Hebart, Stephan Stilgenbauer, Anna-Maria Fink, Kirsten Fischer, Othman Al-Sawaf, Matthias Ritgen, Hartmut Döhner, Francesc Bosch, Sebastian Böttcher, Arnon P. Kater, Eugen Tausch, Ali Aldaoud, Sandra Robrecht, Clemens-Martin Wendtner, Steffen Dörfel, Kathleen Jentsch-Ullrich, Michael Hallek, Jasmin Bahlo, Barbara Eichhorst, Thomas Nösslinger, Paolo Ghia, Karl-Anton Kreuzer, Clinical Haematology, Cancer Center Amsterdam, CCA - Cancer Treatment and Quality of Life, Fink, Anna Maria, Bahlo, Jasmin, Robrecht, Sandra, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Dörfel, Steffen, Fischer, Kirsten, Wendtner, Clemens-Martin, Nösslinger, Thoma, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P, Döhner, Hartmut, Kneba, Michael, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Ritgen, Matthia, Böttcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Subjects
Male, medicine.medical_specialty, Neoplasm, Residual, Antineoplastic Agents, Placebo, Maintenance Chemotherapy, 03 medical and health sciences, 0302 clinical medicine, Maintenance therapy, Chemoimmunotherapy, Internal medicine, Clinical endpoint, medicine, Humans, Lenalidomide, Aged, Aged, 80 and over, Intention-to-treat analysis, business.industry, Hematology, Middle Aged, Interim analysis, Leukemia, Lymphocytic, Chronic, B-Cell, Survival Analysis, Minimal residual disease, Thalidomide, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, Disease Progression, Female, business, 030215 immunology, medicine.drug
Abstract

Summary Background The combined use of genetic markers and detectable minimal residual disease identifies patients with chronic lymphocytic leukaemia with poor outcome after first-line chemoimmunotherapy. We aimed to assess lenalidomide maintenance therapy in these high-risk patients. Methods In this randomised, double-blind, phase 3 study (CLLM1; CLL Maintenance 1 of the German CLL Study Group), patients older than 18 years and diagnosed with immunophenotypically confirmed chronic lymphocytic leukaemia with active disease, who responded to chemoimmunotherapy 2–5 months after completion of first-line therapy and who were assessed as having a high risk for an early progression with at least a partial response after four or more cycles of first-line chemoimmunotherapy, were eligible if they had high minimal residual disease levels or intermediate levels combined with an unmutated IGHV gene status or TP53 alterations. Patients were randomly assigned (2:1) to receive either lenalidomide (5 mg) or placebo. Randomisation was done with a fixed block size of three, and was stratified according to the minimal residual disease level achieved after first-line therapy. Maintenance was started with 5 mg daily, and was escalated to the target dose of 15 mg. If tolerated, medication was administered until disease progression. The primary endpoint was progression-free survival according to an independent review. The pre-planned interim analysis done by intention to treat was done after 20% of the calculated progression-free survival events. This study is registered with ClinicalTrials.gov, number NCT01556776; treatment in the lenalidomide group is still ongoing. Findings Between July 5, 2012, and March 15, 2016, 468 previously untreated patients with chronic lymphocytic leukaemia were screened for the study; 379 (81%) were not eligible. Recruitment was closed prematurely due to poor accrual after 89 of 200 planned patients were randomly assigned: 60 (67%) enrolled patients were assigned to the lenalidomide group and 29 (33%) to the placebo group, of whom 56 (63%) received lenalidomide and 29 (33%) placebo, with a median of 11·0 (IQR 4·5–20·5) treatment cycles at data cutoff. After a median observation time of 17·9 months (IQR 9·1–28·1), the hazard ratio for progression-free survival assessed by an independent review was 0·168 (95% CI 0·074–0·379). Median progression-free survival was 13·3 months (95% CI 9·9–19·7) in the placebo group and not reached (95% CI 32·3–not evaluable) in the lenalidomide group. The most frequent adverse events were skin disorders (35 patients [63%] in the lenalidomide group vs eight patients [28%] in the placebo group), gastrointestinal disorders (34 [61%] vs eight [28%]), infections (30 [54%] vs 19 [66%]), haematological toxicity (28 [50%] vs five [17%]), and general disorders (28 [50%] vs nine [31%]). One fatal adverse event was reported in each of the treatment groups (one [2%] patient with fatal acute lymphocytic leukaemia in the lenalidomide group and one patient (3%) with fatal multifocal leukoencephalopathy in the placebo group). Interpretation Lenalidomide is an efficacious maintenance therapy reducing the relative risk of progression in first-line patients with chronic lymphocytic leukaemia who do not achieve minimal residual disease negative disease state following chemoimmunotherapy approaches. The toxicity seems to be acceptable considering the poor prognosis of the eligible patients. The trial independently confirms the clinical significance of a novel, minimal residual disease-based algorithm to predict short progression-free survival, which might be incorporated in future clinical trials to identify candidates for additional maintenance treatment. Funding Celgene Corporation.

Published
2017

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