Clinical trial NCT01478542: OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients with CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine
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 in Combination with Vitamin D Substitution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: CD20+ Aggressive B-Cell Lymphoma
Keywords: DLBCL
Liposomal Vincristine (Marqibo)
Optimised Rituximab
Toxicity
Elderly Patients
FDG-PET
Bulky Disease
Radiation
age >60 years
First line Therapy
Vitamin D
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: German High-Grade Non-Hodgkin's Lymphoma Study Group
name: Spectrum Pharmaceuticals, Inc
First posted: 2011-11-23
Enrollment: 1152
Sex: ALL
Minimum age (years): 61
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 9 years
Secondary outcomes:
measure: for efficacy: CR-rate, PR-rate, rate of primary progressions, relapse rate, EFS and OS; rate and CTC grades of PNP. Prognostic value of the FDG-PET derived imaging biomarkers for lymphoma load: SUV, MTV, TLG.
timeFrame: 9 years
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University Hospital
state: Saarland
city: Wittenberg
country: Germany
facility: Evangelisches Krankenhaus Paul Gerhardt Stift, Klinik für Innere Medizin II
state: Sachsen-Anhalt
city: Aachen
country: Germany
facility: Klinik für Hämatologie und Onkologie
city: Altötting
country: Germany
facility: Innklinikum Altötting
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg, MVZ
city: Augsburg
country: Germany
facility: Klinikum Augsburg, Medizinische Klinik II
city: Augsburg
country: Germany
facility: Praxis Dres. med. Brudler, Heinrich, Bangerter
city: Aurich
country: Germany
facility: Gemeinschaftspraxis Dres. Reichert, Janssen
city: Bad Saarow
country: Germany
facility: Helios Klinikum Bad Saarow, Klinik für Innere Medizin III
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Med. Klinik V
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth, Medizinische Klinik IV
city: Berlin
country: Germany
facility: Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Med. Klinik III
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum
city: Bonn
country: Germany
facility: Johanniter Krankenhaus Bonn, Abteilung für Innere Medizin I
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Med. Klinik III
city: Brandenburg
country: Germany
facility: Städt. Klinikum Brandenburg, Med. Klinik II
city: Bremen
country: Germany
facility: Evangelisches Diakonie-Krankenhaus Bremen
city: Burgwedel
country: Germany
facility: Praxis Dr. Obst
city: Celle
country: Germany
facility: Praxis Dr. Marquard
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz, Innere Medizin III
city: Coburg
country: Germany
facility: Klinikum Coburg, V. Med. Klinik
city: Coesfeld
country: Germany
facility: Schwerpunktpraxis Dres. Glados/Retzlaff/Zühlsdorf/Deuticke
city: Dortmund
country: Germany
facility: St. Johannes Hospital Dortmund, Med. Klinik II
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Wolf, Illmer
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dres. Mohm, Prange-Krex
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Med. Klinik 5
city: Eschweiler
country: Germany
facility: St.-Antonius-Hospital Eschweiler, Hämatologie und Onkologie
city: Esslingen
country: Germany
facility: Klinikum Esslingen, Klinik für Gastroenterologie, Onkologie und Innere Medizin
city: Frankfurt (Oder)
country: Germany
facility: Klinikum Frankfurt (Oder), Abteilung f. Innere Medizin
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe-Universität Frankfurt, Hämatologie/Onkologie
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest Frankfurt, II. Med. Klinik
city: Freiburg
country: Germany
facility: Praxis Dr. med. Reiber
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Innere Medizin I
city: Fulda
country: Germany
facility: Klinikum Fulda, Med. Klinik III
city: Gelsenkirchen
country: Germany
facility: St. Josef-Hospital Gelsenkirchen, Onkologie und Hämatologie
city: Gießen
country: Germany
facility: Praxis Dr. med. Schliesser
city: Goch
country: Germany
facility: Wilhelm-Anton-Hospital Goch, Innere Medizin
city: Goslar
country: Germany
facility: Onkologische Kooperation Harz, Onkologische Schwerpunktpraxis
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald, Medizinische Universitätsklinik C, Hämatologie und Onkologie
city: Gummersbach
country: Germany
facility: Kreiskrankenhaus Gummersbach
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Hämatologie und Onkologie
city: Gütersloh
country: Germany
facility: Klinikum Gütersloh
city: Hagen
country: Germany
facility: Kath. Krankenhaus Hagen, St.-Marien-Hospital
city: Halle (Saale)
country: Germany
facility: Gemeinschaftspraxis Rohrberg, Hurtz, Schmidt, Frank-Gleich
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg, Hämatologie/Onkologie
city: Hamburg
country: Germany
facility: Hämatolog.-onkolog. Praxis Dres. Müller-Hagen, Bertram, Albertinen-Krankenhaus
city: Hamburg
country: Germany
facility: Hämatologisch-onkologische Praxis Altona (HOPA)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik und Poliklinik, Onkologie und Hämatologie
city: Hannover
country: Germany
facility: Klinikum Hannover-Siloah, Klinik für Hämatologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH), Zentrum für Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
city: Hannover
country: Germany
facility: Praxis MediProjekt
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Innere Medizin V
city: Herford
country: Germany
facility: Klinikum Kreis Herford, Med. Klinik II
city: Hildesheim
country: Germany
facility: Onkologische Schwerpunktpraxis Dres. Freier, Sievers
city: Hildesheim
country: Germany
facility: St. Bernward Krankenhaus Hildesheim, Med. Klinik II
city: Idar-Oberstein
country: Germany
facility: KMT Klinik Idar-Oberstein
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Innere Medizin II
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum, Klinik für Innere Medizin I
city: Kaiserslautern
country: Germany
facility: Praxis Dres Hansen, Reeb
city: Karlsruhe
country: Germany
facility: St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe, II. Med. Klinik, Hämatologie/Onkologie/Infektionskrankheiten
city: Kassel
country: Germany
facility: GMP Dres Siehl, Söling
city: Kassel
country: Germany
facility: Rotes Kreuz Krankenhaus Kassel, Klinik für Interdisziplinäre Onkologie
city: Kempten
country: Germany
facility: Klinikum Kempten-Oberallgäu, Hämatologie, Onkologie und Palliativmedizin
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein, Ev. Stift St. Martin, Innere Medizin
city: Krefeld
country: Germany
facility: Gemeinschaftspraxis Dres. Neise, Lollert
city: Kronach
country: Germany
facility: Praxis Dr. Strauch
city: Köln
country: Germany
facility: Gemeinschaftspraxis Dres. Schmitz, Steinmetz, Severin
city: Köln
country: Germany
facility: Klinikum der Universität zu Köln, Klinik I für Innere Medizin
city: Köln
country: Germany
facility: Krankenhaus Holweide
city: Landshut
country: Germany
facility: Klinikum Landshut, Med. Klinik I
city: Lebach
country: Germany
facility: Caritas Krankenhaus Lebach
city: Leer
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Leipzig
country: Germany
facility: Klinikum St. Georg Leipzig, Abteilung für internistische Onkologie/Hämatologie
city: Lemgo
country: Germany
facility: Klinikum Lippe-Lemgo, Med. Klinik II
city: Lörrach
country: Germany
facility: Onkologische Schwerpunktpraxis Lörrach
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg, Hämatologie/Onkologie
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, III. Med. Klinik und Poliklinik
city: Mannheim
country: Germany
facility: Mannheimer Onkologie Praxis, Dres. Brust, Plöger, Schuster, Hensel
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Minden
country: Germany
facility: Johannes Wesling Klinikum, Klinik für Hämatologie, Onkologie und Palliativmedizin
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin
city: Mönchengladbach
country: Germany
facility: Kliniken Maria-Hilf Mönchengladbach, Innere Medizin I
city: Mülheim an der Ruhr
country: Germany
facility: GMP Dres Schröder/Sieg
city: München Pasing
country: Germany
facility: Praxis Dres. Schmidt, Fromm, Wiesmeier, Seufert, Klapthor, Zingerle
city: München
country: Germany
facility: Klinikum Großhadern, Med. Klinik 3
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München, III. Med.Klinik
city: München
country: Germany
facility: Städtisches Klinikum München Harlaching
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Med. Klinik A
city: Neumarkt
country: Germany
facility: Onkologische Praxis Dr. Ladda
city: Neuss
country: Germany
facility: Lukaskrankenhaus Neuss, Med. Klinik II
city: Nürtingen
country: Germany
facility: Kreiskliniken Esslingen, Klinikum Kirchheim-Nürtingen, Hämatologie, Internist. Onkologie und Palliativmedizin
city: Offenbach
country: Germany
facility: Gemeinschaftspraxis Dres. Balló, Böck
city: Offenburg
country: Germany
facility: Ortenau Klinikum Offenburg-Gegenbach, Medizinische Klinik II
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg, Hämatologie/Onkologie
city: Oldenburg
country: Germany
facility: Onkologische Schwerpunktpraxis Dr. Hübner
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg, Klinik für Strahlentherapie und Internistische Onkologie
city: Olpe
country: Germany
facility: Onkologische Schwerpunktpraxis im MVZ 2 GmbH, Dr. H. Eimermacher
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück, Med. Klinik III
city: Ostfildern
country: Germany
facility: Paracelsus Krankenhaus Ruit, Kreiskliniken Esslingen gGmbH, Zentrum für Allgemeine Innere Medizin
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie
city: Pinneberg
country: Germany
facility: Gemeinschaftspraxis Dres. Baake, Leonhardt, Moegling, am Regio Klinikum Pinneberg
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin
city: Ravensburg
country: Germany
facility: Gemeinschaftspraxis Dres. Decker, Nonnenbroich, Herbrik-Zipp
city: Recklinghausen
country: Germany
facility: Prosper-Hospital Recklinghausen, Med. Klinik I
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
city: Reutlingen
country: Germany
facility: Klinikum am Steinenberg, Kreiskliniken Reutlingen GmbH
city: Riesa
country: Germany
facility: Elblandklinikum Riesa, Klinik für Innere Medizin II
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock, Innere Medizin
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock, Abteilung Hämatologie/Onkologie, Klinik u. Poliklinik für Innere Medizin
city: Saarbrücken
country: Germany
facility: GMP Dres Jacobs, Daus, Schmits
city: Siegburg
country: Germany
facility: ZAHO-Siegburg, Zentrum für ambulante Hämatologie und Onkologie Siegburg
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart, Med. Klinik II
city: Traunstein
country: Germany
facility: Klinikum Traunstein, Hämatologie/Onkologie
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier, I. Med. Abteilung
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Medizinische Klinik und Poliklinik, Onkologie, Hämatologie, Immunologie und Rheumatologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Innere Medizin III
city: Unna
country: Germany
facility: Katharinen Hospital Unna
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum - Innere Medizin II
city: Villingen-Schwenningen
country: Germany
facility: Praxis Onkologie Schwarzwald - Alb
city: Weiden
country: Germany
facility: Med. Versorgungszentrum Weiden, Abteilung für Onkologie
city: Weilheim
country: Germany
facility: Praxis Dres med. Perker, Sandherr
city: Wiesbaden
country: Germany
facility: HSK Wiesbaden, Innere Medizin III
city: Wuppertal
country: Germany
facility: Helios Klinkum Wuppertal, Med. Klinik I
city: Würselen
country: Germany
facility: Hämatologisch-Onkologische Praxis Würselen
Study officials:
affiliation: Saarland University, Saarland University Hospital
name: Lorenz Thurner, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.