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OPTIMAL>60, Improvement of Therapy of Elderly Patients With CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine

Information source: University Hospital, Saarland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: CD20+ Aggressive B-Cell Lymphoma

Intervention: Conventional Vincristine (Drug); Liposomal Vincristine (Drug); Ricover-scheme rituximab (Drug); optimised rituximab-schedule (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospital, Saarland

Official(s) and/or principal investigator(s):
Michael G. Pfreundschuh, Professor, Principal Investigator, Affiliation: Saarland University, Saarland University Hospital

Overall contact:
DSHNHL Central Study Office, Phone: +4968411623084, Email: DSHNHL@uks.eu

Summary

The purpose of this study is to improve the outcome of elderly patients with CD20+ Aggressive B-Cell Lymphoma and to reduce the toxicity of standard used Immuno-Chemotherapy by using an optimised schedule of the monoclonal antibody Rituximab, substituting conventional by Liposomal Vincristine and by a PET-guided reduction of therapy.

Clinical Details

Official title: Improvement of Outcome and Reduction of Toxicity in Elderly Patients With CD20+ Aggressive B-Cell Lymphoma by an Optimised Schedule of the Monoclonal Antibody Rituximab, Substitution of Conventional by Liposomal Vincristine, and FDG-PET Based Reduction of Therapy.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome: for efficacy: rate of complete remissions (CR-rate), rate of partial responses (PR-rate), rate of primary progressions, relapse rate, event-free survival (EFS) and overall survival (OS); rate and CTC grades of polyneuropathy.

Detailed description: Primary objective of study: "OPTIMAL>60 Less Favourable" Patients with less favourable prognosis: 1. To test whether progression-free survival (PFS) can be improved by substituting conventional by liposomal vincristine; 2. To test whether PFS can be improved by 12 optimised applications instead of 8 2-week applications of rituximab. "OPTIMAL>60 Favourable": Patients with favourable pro-gnosis: 3. Comparison of neurotoxicity of conventional and liposomal vincristine; 4. Determination of PFS for the treatment strategy of reducing treatment in patients with negative FDG-PET after 4 x R-CHOP/CHLIP-14 (PET-4) and comparison with the corresponding patient population in RICOVER-60. Secondary objectives: "OPTIMAL>60 Favourable" and "OPTIMAL>60 Less Favourable": 5. Comparison of the prognostic value of a pre-treatment FDG-PET (PET-0) with conventional CT/MRT. 6. Comparison of the FDG-PET-based individualised treatment strategy in OPTIMAL>60 with the fixed (pre-defined) treatment strategy in RICOVER>60. 7. Estimation of the vincristine-related neurotoxicity ("OPTIMAL>60 Less Favourable only, since vincristine related neurotoxicity is primary objective of the study in favourable patients) and other toxicities (all patients). 8. Determination of the therapeutic efficacy of a Vitamin D substitution by comparing the first patients without Vitamin D substitution with patients with Vitamin D substitution.

Eligibility

Minimum age: 61 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age: 61-80 years 2. All risk groups (IPI 1-5) 3. Diagnosis of aggressive CD20+ B-NHL, based on an excisional biopsy of a lymph node or on an appropriate sample of a lymph node or of an extranodal involvement. It will be possible to treat the following entities in this study as defined by the new WHO classification of 200870: B-NHL:

- Foll. lymphoma grade IIIb

- DLBCL, not otherwise specified (NOS)

- common morphologic variants:

- centroblastic

- immunoblastic

- anaplastic

- rare morphologic variants

- DLBCL subtypes/entities:

- T-cell/histiocyte-rich large B-cell lymphoma

- primary cutaneous DLBCL, leg type

- EBV-pos. DLBCL of the elderly

- DLBCL associated with chronic inflammation

- primary mediastinal (thymic) LBCL

- intravascular large B-cell-lymphoma

- ALK-positive large B-cell-lymphoma

- plasmoblastic lymphoma

- primary effusion lymphoma

- secondary or simultaneous high grade B-cell-lymphoma

- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and

Burkitt lymphoma

- B-cell lymphoma, unclassifiable, with features intermediate between DLCBL and

Hodgkin lymphoma

4. Performance status ECOG 0 - 2 after prephase treatment. The performance status of

each patient must be assessed before the initiation and after the end of prephase treatment which, as experience has shown, can result in a significant improvement of the patient's performance status. The pre-treatment performance status which can range from ECOG 0 to ECOG 4 must be documented in the Staging CRF (see ISF); the performance status after the prephase treatment must be documented in the respective Prephase Treatment CRF (PT form: see ISF). A definition of the performance status is provided in Appendix 28. 10. 5. Written informed consent of the patient 6. Contract of participation signed by the study centre and sponsor Exclusion Criteria: 1. Already initiated lymphoma therapy (except for the prephase treatment) 2. Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement), in particular:

- heart: angina pectoris CCS >2, cardiac failure e. g. NYHA >2 and/or EF <50% or

FS<25% in nuclear medicine examination/echocardiography

- lungs: if respiratory problems are suspected the patient is to be excluded if

the resultant pulmonary function test shows FeV1<50% or a diffusion capacity <50% of the reference values

- kidneys: creatinine >2 times the upper reference limit

- liver: bilirubin >2 times the upper reference limit, aspartate transaminase

(AST, SGOT) or alanine transaminase (ALT, SGPT) >3 x institutional upper reference limit

- uncontrollable diabetes mellitus (prephase treatment with predniso[lo]ne!)

3. Platelets <75 000/mm3, leukocytes <2 500/mm3 (if not due to lymphoma) 4. Known hypersensitivity to the medications to be used 5. Known HIV-positivity 6. Patients with severe impairment of immune defense 7. Patients with constipation with imminent risk of ileus 8. Chronic active hepatitis 9. Poor patient compliance 10. Simultaneous participation in other treatment studies or in another clinical trial within the last 6 months 11. Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic drugs for previous disorder 12. Other concomitant tumour disease and/or tumour disease in the past 5 years (except basalioma of the skin and carcinoma in situ) 13. CNS involvement of lymphoma (intracerebral, meningeal, intraspinal intradural) or primary CNS lymphoma 14. Persistent neuropathy grade ≥2 (NCI CTC-AE v4. 03) (unless due to lymphoma involvement) 15. History of persistent active neurologic disorders grade >2 including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, or other demyelinating condition 16. Pregnancy or breast-feeding women 17. Active serious infections not controlled by oral and/or intravenous antibiotics or anti-fungal medication 18. Any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. 19. MALT lymphoma 20. Non-conformity to eligibility criteria 21. Persons not able to understand the impact, nature, risks and consequences of the trial (including language barrier) 22. Persons not agreeing to the transmission of their pseudonymous data 23. Persons depending on sponsor or investigator 24. Persons from highly protected groups. Pts. with CNS lymphoma should not be included in this study.

Locations and Contacts

DSHNHL Central Study Office, Phone: +4968411623084, Email: DSHNHL@uks.eu

Klinikum St. Marien Amberg, MVZ, Amberg, Germany; Recruiting

Klinikum Augsburg, Medizinische Klinik II, Augsburg, Germany; Recruiting

Praxis Dres. med. Brudler, Heinrich, Bangerter, Augsburg, Germany; Recruiting

Gemeinschaftspraxis Dres. Reichert, Janssen, Aurich, Germany; Recruiting

Helios Klinikum Bad Saarow, Klinik für Innere Medizin III, Bad Saarow, Germany; Recruiting

Sozialstiftung Bamberg, Med. Klinik V, Bamberg, Germany; Recruiting

Klinikum Bayreuth, Medizinische Klinik IV, Bayreuth, Germany; Recruiting

Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Med. Klinik III, Berlin, Germany; Recruiting

Knappschaftskrankenhaus Bochum, Bochum, Germany; Recruiting

Johanniter Krankenhaus Bonn, Abteilung für Innere Medizin I, Bonn, Germany; Recruiting

Universitätsklinikum Bonn, Med. Klinik III, Bonn, Germany; Recruiting

Städt. Klinikum Brandenburg, Med. Klinik II, Brandenburg, Germany; Recruiting

Evangelisches Diakonie-Krankenhaus Bremen, Bremen, Germany; Recruiting

Praxis Dr. Obst, Burgwedel, Germany; Recruiting

Praxis Dr. Marquard, Celle, Germany; Recruiting

Klinikum Chemnitz, Innere Medizin III, Chemnitz, Germany; Recruiting

Klinikum Coburg, V. Med. Klinik, Coburg, Germany; Recruiting

Schwerpunktpraxis Dres. Glados/Retzlaff/Zühlsdorf/Deuticke, Coesfeld, Germany; Recruiting

St. Johannes Hospital Dortmund, Med. Klinik II, Dortmund, Germany; Recruiting

BAG Freiberg-Richter, Jacobasch, Wolf, Illmer, Dresden, Germany; Recruiting

Gemeinschaftspraxis Dres. Mohm, Prange-Krex, Dresden, Germany; Recruiting

Universitätsklinikum Erlangen, Med. Klinik 5, Erlangen, Germany; Recruiting

St.-Antonius-Hospital Eschweiler, Hämatologie und Onkologie, Eschweiler, Germany; Recruiting

Klinikum Esslingen, Klinik für Gastroenterologie, Onkologie und Innere Medizin, Esslingen, Germany; Recruiting

Klinikum Frankfurt (Oder), Abteilung f. Innere Medizin, Frankfurt (Oder), Germany; Recruiting

Klinikum der J.W. Goethe-Universität Frankfurt, Hämatologie/Onkologie, Frankfurt, Germany; Recruiting

Krankenhaus Nordwest Frankfurt, II. Med. Klinik, Frankfurt, Germany; Recruiting

Praxis Dr. med. Reiber, Freiburg, Germany; Recruiting

Universitätsklinikum Freiburg, Innere Medizin I, Freiburg, Germany; Recruiting

Klinikum Fulda, Med. Klinik III, Fulda, Germany; Recruiting

St. Josef-Hospital Gelsenkirchen, Onkologie und Hämatologie, Gelsenkirchen, Germany; Recruiting

Praxis Dr. med. Schliesser, Gießen, Germany; Recruiting

Wilhelm-Anton-Hospital Goch, Innere Medizin, Goch, Germany; Recruiting

Onkologische Kooperation Harz, Onkologische Schwerpunktpraxis, Goslar, Germany; Recruiting

Universitätsmedizin Greifswald, Medizinische Universitätsklinik C, Hämatologie und Onkologie, Greifswald, Germany; Recruiting

Kreiskrankenhaus Gummersbach, Gummersbach, Germany; Recruiting

Universitätsmedizin Göttingen, Hämatologie und Onkologie, Göttingen, Germany; Recruiting

Klinikum Gütersloh, Gütersloh, Germany; Recruiting

Kath. Krankenhaus Hagen, St.-Marien-Hospital, Hagen, Germany; Recruiting

Gemeinschaftspraxis Rohrberg, Hurtz, Schmidt, Frank-Gleich, Halle (Saale), Germany; Recruiting

Asklepios Klinik St. Georg, Hämatologie/Onkologie, Hamburg, Germany; Recruiting

Hämatolog.-onkolog. Praxis Dres. Müller-Hagen, Bertram, Albertinen-Krankenhaus, Hamburg, Germany; Recruiting

Hämatologisch-onkologische Praxis Altona (HOPA), Hamburg, Germany; Recruiting

Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik und Poliklinik, Onkologie und Hämatologie, Hamburg, Germany; Recruiting

Klinikum Hannover-Siloah, Med. Klinik III, Hannover, Germany; Recruiting

Medizinische Hochschule Hannover (MHH), Zentrum für Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Hannover, Germany; Recruiting

Praxis MediProjekt, Hannover, Germany; Recruiting

Universitätsklinikum Heidelberg, Innere Medizin V, Heidelberg, Germany; Recruiting

Klinikum Kreis Herford, Med. Klinik II, Herford, Germany; Recruiting

Onkologische Schwerpunktpraxis Dres. Freier, Sievers, Hildesheim, Germany; Recruiting

St. Bernward Krankenhaus Hildesheim, Med. Klinik II, Hildesheim, Germany; Recruiting

KMT Klinik Idar-Oberstein, Idar-Oberstein, Germany; Recruiting

Universitätsklinikum Jena, Klinik für Innere Medizin II, Jena, Germany; Recruiting

Praxis Dres Hansen, Reeb, Kaiserslautern, Germany; Recruiting

St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2, Karlsruhe, Germany; Recruiting

Städtisches Klinikum Karlsruhe, II. Med. Klinik, Hämatologie/Onkologie/Infektionskrankheiten, Karlsruhe, Germany; Recruiting

GMP Dres Siehl, Söling, Kassel, Germany; Recruiting

Rotes Kreuz Krankenhaus Kassel, Klinik für Interdisziplinäre Onkologie, Kassel, Germany; Recruiting

Klinikum Kempten-Oberallgäu, Hämatologie, Onkologie und Palliativmedizin, Kempten, Germany; Recruiting

Universitätsklinikum Schleswig-Holstein (Campus Kiel), Medizinische Klinik II, Kiel, Germany; Recruiting

Gemeinschaftsklinikum Mittelrhein, Ev. Stift St. Martin, Innere Medizin, Koblenz, Germany; Recruiting

Gemeinschaftspraxis Dres. Neise, Lollert, Krefeld, Germany; Recruiting

Praxis Dr. Strauch, Kronach, Germany; Recruiting

Gemeinschaftspraxis Dres. Schmitz, Steinmetz, Severin, Köln, Germany; Recruiting

Klinikum der Universität zu Köln, Klinik I für Innere Medizin, Köln, Germany; Recruiting

Krankenhaus Holweide, Köln, Germany; Recruiting

Klinikum Landshut, Med. Klinik I, Landshut, Germany; Recruiting

Caritas Krankenhaus Lebach, Lebach, Germany; Recruiting

Onkologische Schwerpunktpraxis, Leer, Germany; Recruiting

Klinikum St. Georg Leipzig, Abteilung für internistische Onkologie/Hämatologie, Leipzig, Germany; Recruiting

Klinikum Lippe-Lemgo, Med. Klinik II, Lemgo, Germany; Recruiting

Klinikum d. Stadt Ludwigshafen, Medizinische Klinik A, Ludwigshafen, Germany; Recruiting

Evangelisches Krankenhaus Paul Gerhardt Stift, Klinik für Innere Medizin II, Lutherstadt Wittenberg, Germany; Recruiting

Onkologische Schwerpunktpraxis Lörrach, Lörrach, Germany; Recruiting

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany; Recruiting

Klinikum Magdeburg, Hämatologie/Onkologie, Magdeburg, Germany; Recruiting

Universitätsmedizin Mainz, III. Med. Klinik und Poliklinik, Mainz, Germany; Recruiting

Mannheimer Onkologie Praxis, Dres. Brust, Plöger, Schuster, Hensel, Mannheim, Germany; Recruiting

Universitätsmedizin Mannheim, III. Med. Universitätsklinik, Mannheim, Germany; Recruiting

Universitätsklinikum Gießen und Marburg, Marburg, Germany; Recruiting

Johannes Wesling Klinikum, Klinik für Hämatologie, Onkologie und Palliativmedizin, Minden, Germany; Recruiting

Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin, Mutlangen, Germany; Recruiting

Kliniken Maria-Hilf Mönchengladbach, Innere Medizin I, Mönchengladbach, Germany; Recruiting

GMP Dres Schröder/Sieg, Mülheim an der Ruhr, Germany; Recruiting

Klinikum Großhadern, Med. Klinik 3, München, Germany; Recruiting

Klinikum rechts der Isar der Technischen Universität München, III. Med.Klinik, München, Germany; Recruiting

Praxis Dres. Schick, Schmidt, Fromm, Wiesmeier, Schick, Galler, Klapthor, München, Germany; Recruiting

Städtisches Klinikum München Harlaching, München, Germany; Recruiting

GMP Dres Kriebel-Schmitt, Pelz, Münster, Germany; Recruiting

Onkologische Praxis Dr. Ladda, Neumarkt, Germany; Recruiting

Lukaskrankenhaus Neuss, Med. Klinik II, Neuss, Germany; Recruiting

Kreiskliniken Esslingen, Klinikum Kirchheim-Nürtingen, Hämatologie, Internist. Onkologie und Palliativmedizin, Nürtingen, Germany; Recruiting

Gemeinschaftspraxis Dres. Balló, Böck, Offenbach, Germany; Recruiting

Ortenau Klinikum Offenburg-Gegenbach, Medizinische Klinik II, Offenburg, Germany; Recruiting

Klinikum Oldenburg, Hämatologie/Onkologie, Oldenburg, Germany; Recruiting

Onkologische Schwerpunktpraxis Dr. Hübner, Oldenburg, Germany; Recruiting

Pius Hospital Oldenburg, Klinik für Strahlentherapie und Internistische Onkologie, Oldenburg, Germany; Recruiting

Onkologische Schwerpunktpraxis im MVZ 2 GmbH, Dr. H. Eimermacher, Olpe, Germany; Recruiting

Klinikum Osnabrück, Med. Klinik III, Osnabrück, Germany; Recruiting

Paracelsus Krankenhaus Ruit, Kreiskliniken Esslingen gGmbH, Zentrum für Allgemeine Innere Medizin, Ostfildern, Germany; Recruiting

Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie, Paderborn, Germany; Recruiting

Gemeinschaftspraxis Dres. Baake, Leonhardt, Moegling, am Regio Klinikum Pinneberg, Pinneberg, Germany; Recruiting

Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin, Potsdam, Germany; Recruiting

Gemeinschaftspraxis Dres. Decker, Nonnenbroich, Herbrik-Zipp, Ravensburg, Germany; Recruiting

Prosper-Hospital Recklinghausen, Med. Klinik I, Recklinghausen, Germany; Recruiting

Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie, Regensburg, Germany; Recruiting

Klinikum am Steinenberg, Kreiskliniken Reutlingen GmbH, Reutlingen, Germany; Recruiting

Elblandklinikum Riesa, Klinik für Innere Medizin II, Riesa, Germany; Recruiting

Klinikum Südstadt Rostock, Innere Medizin, Rostock, Germany; Recruiting

Universitätsklinikum Rostock, Abteilung Hämatologie/Onkologie, Klinik u. Poliklinik für Innere Medizin, Rostock, Germany; Recruiting

GMP Dres Jacobs, Daus, Schmits, Saarbrücken, Germany; Recruiting

ZAHO-Siegburg, Zentrum für ambulante Hämatologie und Onkologie Siegburg, Siegburg, Germany; Recruiting

Diakonie-Klinikum Stuttgart, Med. Klinik II, Stuttgart, Germany; Recruiting

Katharinenhospital Stuttgart, Klinik für Hämatologie, Onkologie und Palliativmedizin, Stuttgart, Germany; Recruiting

Klinikum Traunstein, Hämatologie/Onkologie, Traunstein, Germany; Recruiting

Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I, Trier, Germany; Recruiting

Krankenhaus der Barmherzigen Brüder Trier, I. Med. Abteilung, Trier, Germany; Recruiting

Universitätsklinikum Tübingen, Medizinische Klinik und Poliklinik, Onkologie, Hämatologie, Immunologie und Rheumatologie, Tübingen, Germany; Recruiting

Universitätsklinikum Ulm, Innere Medizin III, Ulm, Germany; Recruiting

Katharinen Hospital Unna, Unna, Germany; Recruiting

Med. Versorgungszentrum Weiden, Abteilung für Onkologie, Weiden, Germany; Recruiting

Praxis Dres med. Perker, Sandherr, Weilheim, Germany; Recruiting

HSK Wiesbaden, Innere Medizin III, Wiesbaden, Germany; Recruiting

Helios Klinkum Wuppertal, Med. Klinik I, Wuppertal, Germany; Recruiting

Hämatologisch-Onkologische Praxis Würselen, Würselen, Germany; Recruiting

Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany; Recruiting

Saarland University Hospital, Homburg, Saarland 66421, Germany; Recruiting
Gerhard Held, PD Dr. med., Phone: +4968411683084, Email: gerhard.held@uks.eu
Gerhard Held, PD Dr. med., Principal Investigator

Additional Information

Starting date: November 2011
Last updated: August 13, 2015

Page last updated: August 23, 2015

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