OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients with CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine

NCT ID: NCT01478542

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2024-01-18

Brief 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 in Combination with Vitamin D Substitution.

Detailed Description

Primary objective of study:

"OPTIMAL>60 Less Favourable" Patients with less favourable prognosis: To test whether progression-free survival (PFS) can be improved by substituting conventional by liposomal vincristine; 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 prognosis: Comparison of neurotoxicity of conventional and liposomal vincristine; 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":

Comparison of the prognostic value of a pre-treatment FDG-PET (PET-0) with conventional CT/MRT.

Prospective evaluation on the role of (metabolic) tumor volume to confirm or refuse the hypothesis that optimized rituximab should improve the outcome of patients with a high (metabolic) tumor volume more than that of patients with low MTV and to analyse the substitution of conventional vincristine by liposomal. • 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).

Determination of the therapeutic efficacy of a vitamin D substitution.

Comparison of the FDG-PET-based individualised treatment strategy in OPTIMAL>60 with the fixed (pre-defined) treatment strategy in RICOVER>60.

Investigation of the prognostic value of different FDG-PET derived imaging biomarkers for lymphoma load (SUV, MTV, TLG).

Comparison of the vincristine related neurotoxicity before and after amendment 4.

Comparison of CNS events before and after amendment 4. Comparison of the Cheson, Lugano and RECIL response criteria. Prospective evaluation of the improvement of the prognostic value of ECOG performance status during prephase treatment.

Prospective evaluation of reference pathology biomarkes. Prospective evaluation of circulating tumor DNA (ctDNA), correlation and comparison with PET.

Prospective evaluation of the role of 2 additional cycles of CHOP/CHLIP-14 and involved node radiotherapy in PET-positive patients after 4xR-CHOP/CHLIP-14 in favourable patients.

Evaluation of the role of radiotherapy to PET-positive bulky disease patients after 6xR-CHOP/CHLIP-14 in less favourable patients.

Quality assurance of the performed radiotherapy, including in in-field and outfield relapses.

Investigation of the effect of cross-site ComBat harmonization. Analysis of FDG-PET derived biomarkers in combination with clinical and laboratory variables as distance of lesions and Ann-Arbor stage.

Estimation of the prognostic value of a pre-treatment FDG-PET (PET-0) compared to conventional imaging with CT/MRT.

Prospective evaluation of the prediction of the probability of time-to-progression (TTP) within 2 years by a convolutional neural network trained to analyze maximum intensity projection images from baseline PET.

Analysis regarding molecular subtype, transcriptomics, methylome analysis, spatious analysis of interaction of tumor cells and microenvironment by cyTOF, 3D-morphology (AI-based) or similar techniques, viruses (EBV, HHV6, HHV7), micro-RNA in tumor samples.

Analysis of ctDNA analysis by i) digital droplet PCR, ii) e.g. CAPP or similar methods and iii) methylome analysis as prognostic and predictive marker and comparison with imaging biomarkers.

Analysis special focus on refractory, relapsed courses (including specific patterns of relapse regarding location and time) compared to matched controls and regarding comparison with imaging biomarkers.

Analysis of specific BCR-antigens of aggressive B-NHL as Ars2, SAMD14/neurabin-I in tissue and blood. of initial samples of cases with refractory, relapsing course (including specific patterns of relapse regarding location and time).

Analysis of factors influencing immune effector cells e.g.KIR2DS1 and homozygous HLA-C2, PRF1 A91V or other fHLH variants and prognostic and predictive markers in comparison to RICOVER-60.

Investigation of possible prognostic, or predictive markers of treatment related toxicity as: Neurofilament light chain (NfL) to estimate vincristine-related neurotoxicity, or as clonal hematopoiesis with indeterminate potential (CHIP) and association with cardiovascular events.

Investigation of specific concomitant medication and possible impact on outcome.

Investigation of the efficacy of the modified mandatory infectious prophylaxis OPTIMAL compared to the RICOVER trial with a focus on mandatory chinolon prophylaxis.

Investigation of COVID-19-reated events Impact of interval of diagnosis to time to treatment. Comparison with similar patient populations treated in real-world or prospective clinical trials.

Analysis of EFS and PFS at 24 months (EFS24/PFS24) and its impact on subsequent outcome.

Conditions

CD20+ Aggressive B-Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Favourable Prognosis F-A - Recruitment completed

Induction therapy with 4 cycles of R-CHOP-14 (Rituximab 375 mg/sqm, Cyclophosphamide 750 mg/sqm, Doxorubicin 50 mg/sqm, conventional Vincristine 1,4 mg/sqm \[max. 2mg absolute\], Predniso\[lo\]ne 100mg/d d1-5) and then definitive (post-induction) restaging with FDG-PET. If FDG-PET positive 2 additional cycles of R-CHOP-14 + 2xR plus additional involved-site radiotherapy, if FDG-PET negative only 4xR without radiotherapy.

Group Type: ACTIVE_COMPARATOR

Conventional Vincristine

Intervention Type: DRUG

Favourable F-B - Arm Closed

Induction therapy with 4 cycles of R-CHLIP-14 (Rituximab 375 mg/sqm, Cyclophosphamide 750 mg/sqm, Doxorubicin 50 mg/sqm, liposomal Vincristine 1,4 mg/sqm (max. 2mg absolute), Predniso\[lo\]ne 100mg/d d1-5) and then definitive (post-induction) restaging with FDG-PET. If FDG-PET positive 2 additional cycles of R-CHLIP-14 + 2xR plus additional involved-site radiotherapy, if FDG-PET negative only 4xR without radiotherapy.

Group Type: EXPERIMENTAL

Liposomal Vincristine

Intervention Type: DRUG

Less Favourable LF-A - Recruitment completed

Induction therapy with 6 cycles of R-CHOP-14 (Rituximab 375 mg/sqm, Cyclophosphamide 750 mg/sqm, Doxorubicin 50 mg/sqm, conventional Vincristine 1,4 mg/sqm \[max. 2mg absolute\], Predniso\[lo\]ne 100mg/d d1-5) and then definitive (post-induction) restaging with FDG-PET. If FDG-PET positive 2xR plus additional radiotherapy to the initial bulky region, if FDG-PET negative only 2xR without radiotherapy. After 3xR-CHOP-14 an interim restaging will be performed.

Group Type: ACTIVE_COMPARATOR

Conventional Vincristine

Intervention Type: DRUG

Ricover-scheme rituximab

Intervention Type: DRUG

Less Favourable LF-B - Recruitment completed

Induction therapy with 6 cycles of R-CHLIP-14 (Rituximab 375 mg/sqm, Cyclophosphamide 750 mg/sqm, Doxorubicin 50 mg/sqm, liposomal Vincristine 1,67 mg/sqm \[uncapped\], , Predniso\[lo\]ne 100mg/d d1-5) and then definitive (post-induction) restaging with FDG-PET. If FDG-PET positive 2xR plus additional radiotherapy to the initial bulky region, if FDG-PET negative only 2xR without radiotherapy. After 3xR-CHLIP-14 an interim restaging will be performed. Recruitment completed.

Group Type: EXPERIMENTAL

Liposomal Vincristine

Intervention Type: DRUG

Ricover-scheme rituximab

Intervention Type: DRUG

Less Favourable LF-C - Recruitment completed

Induction therapy with 6 cycles of CHOP-14 (Cyclophosphamide 750 mg/sqm, Doxorubicin 50 mg/sqm, conventional Vincristine 1,4 mg/sqm \[max. 2mg absolute\], Predniso\[lo\]ne 100mg/d d1-5) combined with an optimized Rituximab-schedule (375 mg/sqm, d-4, d-1, d1, d4, d14, d28, d42, d56, d91, d126, d175, d238) and then definitive (post-induction) restaging with FDG-PET. If FDG-PET positive additional radiotherapy to the initial bulky region, if FDG-PET negative omission of radiotherapy. After 3x CHOP-14 an interim restaging will be performed. Recruitment completed.

Group Type: EXPERIMENTAL

Conventional Vincristine

Intervention Type: DRUG

optimised rituximab-schedule

Intervention Type: DRUG

Less Favourable LF-D - Recruitment completed

Induction therapy with 6 cycles of CHLIP-14 (Cyclophosphamide 750 mg/sqm, Doxorubicin 50 mg/sqm, 1,67 mg/sqm \[uncapped\], , Predniso\[lo\]ne 100mg/d d1-5) combined with an optimised Rituximab-schedule (375 mg/sqm, d-4, d-1, d1, d4, d14, d28, d42, d56, d91, d126, d175, d238) and then definitive (post-induction) restaging with FDG-PET. If FDG-PET positive additional radiotherapy to the initial bulky region, if FDG-PET negative omission of radiotherapy. After 3x CHLIP-14 an interim restaging will be performed. Recruitment completed.

Group Type: EXPERIMENTAL

Liposomal Vincristine

Intervention Type: DRUG

optimised rituximab-schedule

Intervention Type: DRUG

Interventions

Conventional Vincristine

Intervention Type: DRUG

Liposomal Vincristine

Intervention Type: DRUG

Ricover-scheme rituximab

Intervention Type: DRUG

optimised rituximab-schedule

Intervention Type: DRUG

Eligibility 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
• transformed indolent 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 for localised skin tumors other than melanoma and carcinomas in situ of any other origin)

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.

• Minimum Eligible Age: 61 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German High-Grade Non-Hodgkin's Lymphoma Study Group

OTHER

Sponsor Role: collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Universität des Saarlandes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenz Thurner, Professor

Role: PRINCIPAL_INVESTIGATOR

Saarland University, Saarland University Hospital

Locations

Saarland University Hospital

Homburg, Saarland, Germany

Evangelisches Krankenhaus Paul Gerhardt Stift, Klinik für Innere Medizin II

Wittenberg, Saxony-Anhalt, Germany

Klinik für Hämatologie und Onkologie

Aachen, , Germany

Innklinikum Altötting

Altötting, , Germany

Klinikum St. Marien Amberg, MVZ

Amberg, , Germany

Klinikum Augsburg, Medizinische Klinik II

Augsburg, , Germany

Praxis Dres. med. Brudler, Heinrich, Bangerter

Augsburg, , Germany

Gemeinschaftspraxis Dres. Reichert, Janssen

Aurich, , Germany

Helios Klinikum Bad Saarow, Klinik für Innere Medizin III

Bad Saarow, , Germany

Sozialstiftung Bamberg, Med. Klinik V

Bamberg, , Germany

Klinikum Bayreuth, Medizinische Klinik IV

Bayreuth, , Germany

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

Berlin, , Germany

Knappschaftskrankenhaus Bochum

Bochum, , Germany

Johanniter Krankenhaus Bonn, Abteilung für Innere Medizin I

Bonn, , Germany

Universitätsklinikum Bonn, Med. Klinik III

Bonn, , Germany

Städt. Klinikum Brandenburg, Med. Klinik II

Brandenburg, , Germany

Evangelisches Diakonie-Krankenhaus Bremen

Bremen, , Germany

Praxis Dr. Obst

Burgwedel, , Germany

Praxis Dr. Marquard

Celle, , Germany

Klinikum Chemnitz, Innere Medizin III

Chemnitz, , Germany

Klinikum Coburg, V. Med. Klinik

Coburg, , Germany

Schwerpunktpraxis Dres. Glados/Retzlaff/Zühlsdorf/Deuticke

Coesfeld, , Germany

Gemeinschaftspraxis Dres. Schmitz, Steinmetz, Severin

Cologne, , Germany

Klinikum der Universität zu Köln, Klinik I für Innere Medizin

Cologne, , Germany

Krankenhaus Holweide

Cologne, , Germany

St. Johannes Hospital Dortmund, Med. Klinik II

Dortmund, , Germany

BAG Freiberg-Richter, Jacobasch, Wolf, Illmer

Dresden, , Germany

Gemeinschaftspraxis Dres. Mohm, Prange-Krex

Dresden, , Germany

Universitätsklinikum Erlangen, Med. Klinik 5

Erlangen, , Germany

St.-Antonius-Hospital Eschweiler, Hämatologie und Onkologie

Eschweiler, , Germany

Klinikum Esslingen, Klinik für Gastroenterologie, Onkologie und Innere Medizin

Esslingen am Neckar, , Germany

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

Frankfurt, , Germany

Krankenhaus Nordwest Frankfurt, II. Med. Klinik

Frankfurt, , Germany

Klinikum Frankfurt (Oder), Abteilung f. Innere Medizin

Frankfurt (Oder), , Germany

Praxis Dr. med. Reiber

Freiburg im Breisgau, , Germany

Universitätsklinikum Freiburg, Innere Medizin I

Freiburg im Breisgau, , Germany

Klinikum Fulda, Med. Klinik III

Fulda, , Germany

St. Josef-Hospital Gelsenkirchen, Onkologie und Hämatologie

Gelsenkirchen, , Germany

Praxis Dr. med. Schliesser

Giessen, , Germany

Wilhelm-Anton-Hospital Goch, Innere Medizin

Goch, , Germany

Onkologische Kooperation Harz, Onkologische Schwerpunktpraxis

Goslar, , Germany

Universitätsmedizin Göttingen, Hämatologie und Onkologie

Göttingen, , Germany

Universitätsmedizin Greifswald, Medizinische Universitätsklinik C, Hämatologie und Onkologie

Greifswald, , Germany

Kreiskrankenhaus Gummersbach

Gummersbach, , Germany

Klinikum Gütersloh

Gütersloh, , Germany

Kath. Krankenhaus Hagen, St.-Marien-Hospital

Hagen, , Germany

Gemeinschaftspraxis Rohrberg, Hurtz, Schmidt, Frank-Gleich

Halle, , Germany

Asklepios Klinik St. Georg, Hämatologie/Onkologie

Hamburg, , Germany

Hämatolog.-onkolog. Praxis Dres. Müller-Hagen, Bertram, Albertinen-Krankenhaus

Hamburg, , Germany

Hämatologisch-onkologische Praxis Altona (HOPA)

Hamburg, , Germany

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

Hamburg, , Germany

Klinikum Hannover-Siloah, Klinik für Hämatologie

Hanover, , Germany

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

Hanover, , Germany

Praxis MediProjekt

Hanover, , Germany

Universitätsklinikum Heidelberg, Innere Medizin V

Heidelberg, , Germany

Klinikum Kreis Herford, Med. Klinik II

Herford, , Germany

Onkologische Schwerpunktpraxis Dres. Freier, Sievers

Hildesheim, , Germany

St. Bernward Krankenhaus Hildesheim, Med. Klinik II

Hildesheim, , Germany

KMT Klinik Idar-Oberstein

Idar-Oberstein, , Germany

Universitätsklinikum Jena, Klinik für Innere Medizin II

Jena, , Germany

Westpfalz-Klinikum, Klinik für Innere Medizin I

Kaiserslautern, , Germany

Praxis Dres Hansen, Reeb

Kaiserslautern, , Germany

St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2

Karlsruhe, , Germany

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

Karlsruhe, , Germany

GMP Dres Siehl, Söling

Kassel, , Germany

Rotes Kreuz Krankenhaus Kassel, Klinik für Interdisziplinäre Onkologie

Kassel, , Germany

Klinikum Kempten-Oberallgäu, Hämatologie, Onkologie und Palliativmedizin

Kempten, , Germany

Gemeinschaftsklinikum Mittelrhein, Ev. Stift St. Martin, Innere Medizin

Koblenz, , Germany

Gemeinschaftspraxis Dres. Neise, Lollert

Krefeld, , Germany

Praxis Dr. Strauch

Kronach, , Germany

Klinikum Landshut, Med. Klinik I

Landshut, , Germany

Caritas Krankenhaus Lebach

Lebach, , Germany

Onkologische Schwerpunktpraxis

Leer, , Germany

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

Leipzig, , Germany

Klinikum Lippe-Lemgo, Med. Klinik II

Lemgo, , Germany

Onkologische Schwerpunktpraxis Lörrach

Loerrach, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Klinikum Magdeburg, Hämatologie/Onkologie

Magdeburg, , Germany

Universitätsmedizin Mainz, III. Med. Klinik und Poliklinik

Mainz, , Germany

Mannheimer Onkologie Praxis, Dres. Brust, Plöger, Schuster, Hensel

Mannheim, , Germany

Universitätsklinikum Gießen und Marburg

Marburg, , Germany

Johannes Wesling Klinikum, Klinik für Hämatologie, Onkologie und Palliativmedizin

Minden, , Germany

Kliniken Maria-Hilf Mönchengladbach, Innere Medizin I

Mönchengladbach, , Germany

Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin

Mutlangen, , Germany

GMP Dres Schröder/Sieg

Mülheim, , Germany

Klinikum Großhadern, Med. Klinik 3

München, , Germany

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

München, , Germany

Städtisches Klinikum München Harlaching

München, , Germany

Praxis Dres. Schmidt, Fromm, Wiesmeier, Seufert, Klapthor, Zingerle

München Pasing, , Germany

Universitätsklinikum Münster, Med. Klinik A

Münster, , Germany

Onkologische Praxis Dr. Ladda

Neumarkt, , Germany

Lukaskrankenhaus Neuss, Med. Klinik II

Neuss, , Germany

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

Nürtingen, , Germany

Gemeinschaftspraxis Dres. Balló, Böck

Offenbach, , Germany

Ortenau Klinikum Offenburg-Gegenbach, Medizinische Klinik II

Offenburg, , Germany

Klinikum Oldenburg, Hämatologie/Onkologie

Oldenburg, , Germany

Onkologische Schwerpunktpraxis Dr. Hübner

Oldenburg, , Germany

Pius Hospital Oldenburg, Klinik für Strahlentherapie und Internistische Onkologie

Oldenburg, , Germany

Onkologische Schwerpunktpraxis im MVZ 2 GmbH, Dr. H. Eimermacher

Olpe, , Germany

Klinikum Osnabrück, Med. Klinik III

Osnabrück, , Germany

Paracelsus Krankenhaus Ruit, Kreiskliniken Esslingen gGmbH, Zentrum für Allgemeine Innere Medizin

Ostfildern, , Germany

Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie

Paderborn, , Germany

Gemeinschaftspraxis Dres. Baake, Leonhardt, Moegling, am Regio Klinikum Pinneberg

Pinneberg, , Germany

Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin

Potsdam, , Germany

Gemeinschaftspraxis Dres. Decker, Nonnenbroich, Herbrik-Zipp

Ravensburg, , Germany

Prosper-Hospital Recklinghausen, Med. Klinik I

Recklinghausen, , Germany

Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie

Regensburg, , Germany

Klinikum am Steinenberg, Kreiskliniken Reutlingen GmbH

Reutlingen, , Germany

Elblandklinikum Riesa, Klinik für Innere Medizin II

Riesa, , Germany

Klinikum Südstadt Rostock, Innere Medizin

Rostock, , Germany

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

Rostock, , Germany

GMP Dres Jacobs, Daus, Schmits

Saarbrücken, , Germany

ZAHO-Siegburg, Zentrum für ambulante Hämatologie und Onkologie Siegburg

Siegburg, , Germany

Diakonie-Klinikum Stuttgart, Med. Klinik II

Stuttgart, , Germany

Klinikum Traunstein, Hämatologie/Onkologie

Traunstein, , Germany

Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I

Trier, , Germany

Krankenhaus der Barmherzigen Brüder Trier, I. Med. Abteilung

Trier, , Germany

Universitätsklinikum Tübingen, Medizinische Klinik und Poliklinik, Onkologie, Hämatologie, Immunologie und Rheumatologie

Tübingen, , Germany

Universitätsklinikum Ulm, Innere Medizin III

Ulm, , Germany

Katharinen Hospital Unna

Unna, , Germany

Schwarzwald-Baar-Klinikum - Innere Medizin II

Villingen-Schwenningen, , Germany

Praxis Onkologie Schwarzwald - Alb

Villingen-Schwenningen, , Germany

Med. Versorgungszentrum Weiden, Abteilung für Onkologie

Weiden, , Germany

Praxis Dres med. Perker, Sandherr

Weilheim, , Germany

HSK Wiesbaden, Innere Medizin III

Wiesbaden, , Germany

Helios Klinkum Wuppertal, Med. Klinik I

Wuppertal, , Germany

Hämatologisch-Onkologische Praxis Würselen

Würselen, , Germany

Countries

Germany

References

Pfreundschuh, M., Christofyllakis, K., Altmann, B., Ziepert, M., Haenel, M., Viardot, A., Neubauer, A., Held, G., Truemper, L., Dreyling, M., Kanz, L., Hallek, M., Schmitz, N., Heintges, T., Kölbel, C., Buecker, A., Ruebe, C., Hellwig, D., Berdel, C., Poeschel, V., and Murawski, N. (2017) Radiotherapy to bulky disease PET-negative after immunochemotherapy in elderly DLBCL patients: Results of a planned interim analysis of the first 187 patients with bulky disease treated in the OPTIMAL>60 study of the DSHNHL. Hematological Oncology, 35( S2): 129- 130. doi: 10.1002/hon.2437_119.

Reference Type: BACKGROUND

Kaddu-Mulindwa D, Altmann B, Held G, Angel S, Stilgenbauer S, Thurner L, Bewarder M, Schwier M, Pfreundschuh M, Loffler M, Menhart K, Grosse J, Ziepert M, Herrmann K, Duhrsen U, Huttmann A, Barbato F, Poeschel V, Hellwig D. FDG PET/CT to detect bone marrow involvement in the initial staging of patients with aggressive non-Hodgkin lymphoma: results from the prospective, multicenter PETAL and OPTIMAL>60 trials. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3550-3559. doi: 10.1007/s00259-021-05348-6. Epub 2021 Apr 29.

Reference Type: DERIVED

PMID: 33928400 (View on PubMed)

Other Identifiers

DSHNHL 2009-1

Identifier Type: -

Identifier Source: org_study_id