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

Primary Purpose

CD20+ Aggressive B-Cell Lymphoma

Status
Active
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Conventional Vincristine
Liposomal Vincristine
Ricover-scheme rituximab
optimised rituximab-schedule
Sponsored by
Universität des Saarlandes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD20+ Aggressive B-Cell Lymphoma focused on measuring DLBCL, Liposomal Vincristine (Marqibo), Optimised Rituximab, Toxicity, Elderly Patients, FDG-PET, Bulky Disease, Radiation, age >60 years, First line Therapy, Vitamin D

Eligibility Criteria

61 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saarland University Hospital
  • Evangelisches Krankenhaus Paul Gerhardt Stift, Klinik für Innere Medizin II
  • Klinik für Hämatologie und Onkologie
  • Klinikum St. Marien Amberg, MVZ
  • Klinikum Augsburg, Medizinische Klinik II
  • Praxis Dres. med. Brudler, Heinrich, Bangerter
  • Gemeinschaftspraxis Dres. Reichert, Janssen
  • Helios Klinikum Bad Saarow, Klinik für Innere Medizin III
  • Sozialstiftung Bamberg, Med. Klinik V
  • Klinikum Bayreuth, Medizinische Klinik IV
  • Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Med. Klinik III
  • Knappschaftskrankenhaus Bochum
  • Johanniter Krankenhaus Bonn, Abteilung für Innere Medizin I
  • Universitätsklinikum Bonn, Med. Klinik III
  • Städt. Klinikum Brandenburg, Med. Klinik II
  • Evangelisches Diakonie-Krankenhaus Bremen
  • Praxis Dr. Obst
  • Praxis Dr. Marquard
  • Klinikum Chemnitz, Innere Medizin III
  • Klinikum Coburg, V. Med. Klinik
  • Schwerpunktpraxis Dres. Glados/Retzlaff/Zühlsdorf/Deuticke
  • St. Johannes Hospital Dortmund, Med. Klinik II
  • BAG Freiberg-Richter, Jacobasch, Wolf, Illmer
  • Gemeinschaftspraxis Dres. Mohm, Prange-Krex
  • Universitätsklinikum Erlangen, Med. Klinik 5
  • St.-Antonius-Hospital Eschweiler, Hämatologie und Onkologie
  • Klinikum Esslingen, Klinik für Gastroenterologie, Onkologie und Innere Medizin
  • Klinikum Frankfurt (Oder), Abteilung f. Innere Medizin
  • Klinikum der J.W. Goethe-Universität Frankfurt, Hämatologie/Onkologie
  • Krankenhaus Nordwest Frankfurt, II. Med. Klinik
  • Praxis Dr. med. Reiber
  • Universitätsklinikum Freiburg, Innere Medizin I
  • Klinikum Fulda, Med. Klinik III
  • St. Josef-Hospital Gelsenkirchen, Onkologie und Hämatologie
  • Praxis Dr. med. Schliesser
  • Wilhelm-Anton-Hospital Goch, Innere Medizin
  • Onkologische Kooperation Harz, Onkologische Schwerpunktpraxis
  • Universitätsmedizin Greifswald, Medizinische Universitätsklinik C, Hämatologie und Onkologie
  • Kreiskrankenhaus Gummersbach
  • Universitätsmedizin Göttingen, Hämatologie und Onkologie
  • Klinikum Gütersloh
  • Kath. Krankenhaus Hagen, St.-Marien-Hospital
  • Gemeinschaftspraxis Rohrberg, Hurtz, Schmidt, Frank-Gleich
  • Asklepios Klinik St. Georg, Hämatologie/Onkologie
  • Hämatolog.-onkolog. Praxis Dres. Müller-Hagen, Bertram, Albertinen-Krankenhaus
  • Hämatologisch-onkologische Praxis Altona (HOPA)
  • Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik und Poliklinik, Onkologie und Hämatologie
  • Klinikum Hannover-Siloah, Klinik für Hämatologie
  • Medizinische Hochschule Hannover (MHH), Zentrum für Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
  • Praxis MediProjekt
  • Universitätsklinikum Heidelberg, Innere Medizin V
  • Klinikum Kreis Herford, Med. Klinik II
  • Onkologische Schwerpunktpraxis Dres. Freier, Sievers
  • St. Bernward Krankenhaus Hildesheim, Med. Klinik II
  • KMT Klinik Idar-Oberstein
  • Universitätsklinikum Jena, Klinik für Innere Medizin II
  • Westpfalz-Klinikum, Klinik für Innere Medizin I
  • Praxis Dres Hansen, Reeb
  • St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2
  • Städtisches Klinikum Karlsruhe, II. Med. Klinik, Hämatologie/Onkologie/Infektionskrankheiten
  • GMP Dres Siehl, Söling
  • Rotes Kreuz Krankenhaus Kassel, Klinik für Interdisziplinäre Onkologie
  • Klinikum Kempten-Oberallgäu, Hämatologie, Onkologie und Palliativmedizin
  • Gemeinschaftsklinikum Mittelrhein, Ev. Stift St. Martin, Innere Medizin
  • Gemeinschaftspraxis Dres. Neise, Lollert
  • Praxis Dr. Strauch
  • Gemeinschaftspraxis Dres. Schmitz, Steinmetz, Severin
  • Klinikum der Universität zu Köln, Klinik I für Innere Medizin
  • Krankenhaus Holweide
  • Klinikum Landshut, Med. Klinik I
  • Caritas Krankenhaus Lebach
  • Onkologische Schwerpunktpraxis
  • Klinikum St. Georg Leipzig, Abteilung für internistische Onkologie/Hämatologie
  • Klinikum Lippe-Lemgo, Med. Klinik II
  • Onkologische Schwerpunktpraxis Lörrach
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Klinikum Magdeburg, Hämatologie/Onkologie
  • Universitätsmedizin Mainz, III. Med. Klinik und Poliklinik
  • Mannheimer Onkologie Praxis, Dres. Brust, Plöger, Schuster, Hensel
  • Universitätsklinikum Gießen und Marburg
  • Johannes Wesling Klinikum, Klinik für Hämatologie, Onkologie und Palliativmedizin
  • Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin
  • Kliniken Maria-Hilf Mönchengladbach, Innere Medizin I
  • GMP Dres Schröder/Sieg
  • Praxis Dres. Schmidt, Fromm, Wiesmeier, Seufert, Klapthor, Zingerle
  • Klinikum Großhadern, Med. Klinik 3
  • Klinikum rechts der Isar der Technischen Universität München, III. Med.Klinik
  • Städtisches Klinikum München Harlaching
  • Universitätsklinikum Münster, Med. Klinik A
  • Onkologische Praxis Dr. Ladda
  • Lukaskrankenhaus Neuss, Med. Klinik II
  • Kreiskliniken Esslingen, Klinikum Kirchheim-Nürtingen, Hämatologie, Internist. Onkologie und Palliativmedizin
  • Gemeinschaftspraxis Dres. Balló, Böck
  • Ortenau Klinikum Offenburg-Gegenbach, Medizinische Klinik II
  • Klinikum Oldenburg, Hämatologie/Onkologie
  • Onkologische Schwerpunktpraxis Dr. Hübner
  • Pius Hospital Oldenburg, Klinik für Strahlentherapie und Internistische Onkologie
  • Onkologische Schwerpunktpraxis im MVZ 2 GmbH, Dr. H. Eimermacher
  • Klinikum Osnabrück, Med. Klinik III
  • Paracelsus Krankenhaus Ruit, Kreiskliniken Esslingen gGmbH, Zentrum für Allgemeine Innere Medizin
  • Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie
  • Gemeinschaftspraxis Dres. Baake, Leonhardt, Moegling, am Regio Klinikum Pinneberg
  • Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin
  • Gemeinschaftspraxis Dres. Decker, Nonnenbroich, Herbrik-Zipp
  • Prosper-Hospital Recklinghausen, Med. Klinik I
  • Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
  • Klinikum am Steinenberg, Kreiskliniken Reutlingen GmbH
  • Elblandklinikum Riesa, Klinik für Innere Medizin II
  • Klinikum Südstadt Rostock, Innere Medizin
  • Universitätsklinikum Rostock, Abteilung Hämatologie/Onkologie, Klinik u. Poliklinik für Innere Medizin
  • GMP Dres Jacobs, Daus, Schmits
  • ZAHO-Siegburg, Zentrum für ambulante Hämatologie und Onkologie Siegburg
  • Diakonie-Klinikum Stuttgart, Med. Klinik II
  • Klinikum Traunstein, Hämatologie/Onkologie
  • Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I
  • Krankenhaus der Barmherzigen Brüder Trier, I. Med. Abteilung
  • Universitätsklinikum Tübingen, Medizinische Klinik und Poliklinik, Onkologie, Hämatologie, Immunologie und Rheumatologie
  • Universitätsklinikum Ulm, Innere Medizin III
  • Katharinen Hospital Unna
  • Schwarzwald-Baar-Klinikum - Innere Medizin II
  • Praxis Onkologie Schwarzwald - Alb
  • Med. Versorgungszentrum Weiden, Abteilung für Onkologie
  • Praxis Dres med. Perker, Sandherr
  • HSK Wiesbaden, Innere Medizin III
  • Helios Klinkum Wuppertal, Med. Klinik I
  • Hämatologisch-Onkologische Praxis Würselen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Favourable Prognosis F-A - Recruitment completed

Favourable F-B - Arm Closed

Less Favourable LF-A - Recruitment completed

Less Favourable LF-B - Recruitment completed

Less Favourable LF-C - Recruitment completed

Less Favourable LF-D - Recruitment completed

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival
"OPTIMAL>60 Less Favourable": To test the effects of substitution of conventional by liposomal vincristine and of a 2-week applications of 8x rituximab by an optimised application of 12 x rituximab stratified log rank tests will be performed for each question (stratified for IPI-factors). Proportional hazard models will be used to investigate treatment interaction and to obtain estimates for the single treatment effects (HR) adjusting for the IPI-factors. "OPTIMAL>60 Favourable" Grade of neurotoxicity will be estimated and indicated with a 95% confidence interval (CI) separated to each type of vincristine. To investigate the 3-year PFS with 95% CI the Kaplan-Meier estimator will be used.

Secondary Outcome Measures

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.
Secondary endpoints: To analyze how (i. e. in which direction) and how often a pre-treatment FDG-PET-based assignment (PET-0) would have affected the assignment of a patient to a different stage, IPI risk group or treatment, respectively. The different FDG-PET derived imaging biomarkers for lymphoma load (SUV, MTV, TLG) will be analyzed for their relationship with CR-rate, PR-rate, rate of primary progressions, relapse rate, EFS, PFS and OS. To compare the efficacy and side effects of the (post-induction therapy FDG-PET-based) individualised treatment strategy in OPTIMAL>60 with the fixed (pre-defined) treatment strategy in RICOVER-60. Rates and grades of polyneuropathy will be determined according to CTC-v4.03. Comparison of the patients without vitamin-D-substitution with patients receiving a vitamin-D-substitution.

Full Information

First Posted
November 18, 2011
Last Updated
May 9, 2023
Sponsor
Universität des Saarlandes
Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group, Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01478542
Brief Title
OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients With CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine
Acronym
OPTIMAL>60
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universität des Saarlandes
Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group, Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Favourable Prognosis F-A - Recruitment completed
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Favourable F-B - Arm Closed
Arm Type
Experimental
Arm Description
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.
Arm Title
Less Favourable LF-A - Recruitment completed
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Less Favourable LF-B - Recruitment completed
Arm Type
Experimental
Arm Description
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.
Arm Title
Less Favourable LF-C - Recruitment completed
Arm Type
Experimental
Arm Description
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.
Arm Title
Less Favourable LF-D - Recruitment completed
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Conventional Vincristine
Intervention Type
Drug
Intervention Name(s)
Liposomal Vincristine
Intervention Type
Drug
Intervention Name(s)
Ricover-scheme rituximab
Intervention Type
Drug
Intervention Name(s)
optimised rituximab-schedule
Primary Outcome Measure Information:
Title
Progression-free survival
Description
"OPTIMAL>60 Less Favourable": To test the effects of substitution of conventional by liposomal vincristine and of a 2-week applications of 8x rituximab by an optimised application of 12 x rituximab stratified log rank tests will be performed for each question (stratified for IPI-factors). Proportional hazard models will be used to investigate treatment interaction and to obtain estimates for the single treatment effects (HR) adjusting for the IPI-factors. "OPTIMAL>60 Favourable" Grade of neurotoxicity will be estimated and indicated with a 95% confidence interval (CI) separated to each type of vincristine. To investigate the 3-year PFS with 95% CI the Kaplan-Meier estimator will be used.
Time Frame
9 years
Secondary Outcome Measure Information:
Title
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.
Description
Secondary endpoints: To analyze how (i. e. in which direction) and how often a pre-treatment FDG-PET-based assignment (PET-0) would have affected the assignment of a patient to a different stage, IPI risk group or treatment, respectively. The different FDG-PET derived imaging biomarkers for lymphoma load (SUV, MTV, TLG) will be analyzed for their relationship with CR-rate, PR-rate, rate of primary progressions, relapse rate, EFS, PFS and OS. To compare the efficacy and side effects of the (post-induction therapy FDG-PET-based) individualised treatment strategy in OPTIMAL>60 with the fixed (pre-defined) treatment strategy in RICOVER-60. Rates and grades of polyneuropathy will be determined according to CTC-v4.03. Comparison of the patients without vitamin-D-substitution with patients receiving a vitamin-D-substitution.
Time Frame
9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 61-80 years All risk groups (IPI 1-5) 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 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. Written informed consent of the patient Contract of participation signed by the study centre and sponsor Exclusion Criteria: Already initiated lymphoma therapy (except for the prephase treatment) 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!) Platelets <75 000/mm3, leukocytes <2 500/mm3 (if not due to lymphoma) Known hypersensitivity to the medications to be used Known HIV-positivity Patients with severe impairment of immune defense Patients with constipation with imminent risk of ileus Chronic active hepatitis Poor patient compliance Simultaneous participation in other treatment studies or in another clinical trial within the last 6 months Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic drugs for previous disorder 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) CNS involvement of lymphoma (intracerebral, meningeal, intraspinal intradural) or primary CNS lymphoma Persistent neuropathy grade ≥2 (NCI CTC-AE v4.03) (unless due to lymphoma involvement) History of persistent active neurologic disorders grade >2 including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, or other demyelinating condition Pregnancy or breast-feeding women Active serious infections not controlled by oral and/or intravenous antibiotics or anti-fungal medication Any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. MALT lymphoma Non-conformity to eligibility criteria Persons not able to understand the impact, nature, risks and consequences of the trial (including language barrier) Persons not agreeing to the transmission of their pseudonymous data Persons depending on sponsor or investigator Persons from highly protected groups. Pts. with CNS lymphoma should not be included in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Held, Professor
Organizational Affiliation
Saarland University, Saarland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saarland University Hospital
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Evangelisches Krankenhaus Paul Gerhardt Stift, Klinik für Innere Medizin II
City
Wittenberg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06886
Country
Germany
Facility Name
Klinik für Hämatologie und Onkologie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum St. Marien Amberg, MVZ
City
Amberg
Country
Germany
Facility Name
Klinikum Augsburg, Medizinische Klinik II
City
Augsburg
Country
Germany
Facility Name
Praxis Dres. med. Brudler, Heinrich, Bangerter
City
Augsburg
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Reichert, Janssen
City
Aurich
Country
Germany
Facility Name
Helios Klinikum Bad Saarow, Klinik für Innere Medizin III
City
Bad Saarow
Country
Germany
Facility Name
Sozialstiftung Bamberg, Med. Klinik V
City
Bamberg
Country
Germany
Facility Name
Klinikum Bayreuth, Medizinische Klinik IV
City
Bayreuth
Country
Germany
Facility Name
Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Med. Klinik III
City
Berlin
Country
Germany
Facility Name
Knappschaftskrankenhaus Bochum
City
Bochum
Country
Germany
Facility Name
Johanniter Krankenhaus Bonn, Abteilung für Innere Medizin I
City
Bonn
Country
Germany
Facility Name
Universitätsklinikum Bonn, Med. Klinik III
City
Bonn
Country
Germany
Facility Name
Städt. Klinikum Brandenburg, Med. Klinik II
City
Brandenburg
Country
Germany
Facility Name
Evangelisches Diakonie-Krankenhaus Bremen
City
Bremen
Country
Germany
Facility Name
Praxis Dr. Obst
City
Burgwedel
Country
Germany
Facility Name
Praxis Dr. Marquard
City
Celle
Country
Germany
Facility Name
Klinikum Chemnitz, Innere Medizin III
City
Chemnitz
Country
Germany
Facility Name
Klinikum Coburg, V. Med. Klinik
City
Coburg
Country
Germany
Facility Name
Schwerpunktpraxis Dres. Glados/Retzlaff/Zühlsdorf/Deuticke
City
Coesfeld
Country
Germany
Facility Name
St. Johannes Hospital Dortmund, Med. Klinik II
City
Dortmund
Country
Germany
Facility Name
BAG Freiberg-Richter, Jacobasch, Wolf, Illmer
City
Dresden
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Mohm, Prange-Krex
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Med. Klinik 5
City
Erlangen
Country
Germany
Facility Name
St.-Antonius-Hospital Eschweiler, Hämatologie und Onkologie
City
Eschweiler
Country
Germany
Facility Name
Klinikum Esslingen, Klinik für Gastroenterologie, Onkologie und Innere Medizin
City
Esslingen
Country
Germany
Facility Name
Klinikum Frankfurt (Oder), Abteilung f. Innere Medizin
City
Frankfurt (Oder)
Country
Germany
Facility Name
Klinikum der J.W. Goethe-Universität Frankfurt, Hämatologie/Onkologie
City
Frankfurt
Country
Germany
Facility Name
Krankenhaus Nordwest Frankfurt, II. Med. Klinik
City
Frankfurt
Country
Germany
Facility Name
Praxis Dr. med. Reiber
City
Freiburg
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Innere Medizin I
City
Freiburg
Country
Germany
Facility Name
Klinikum Fulda, Med. Klinik III
City
Fulda
Country
Germany
Facility Name
St. Josef-Hospital Gelsenkirchen, Onkologie und Hämatologie
City
Gelsenkirchen
Country
Germany
Facility Name
Praxis Dr. med. Schliesser
City
Gießen
Country
Germany
Facility Name
Wilhelm-Anton-Hospital Goch, Innere Medizin
City
Goch
Country
Germany
Facility Name
Onkologische Kooperation Harz, Onkologische Schwerpunktpraxis
City
Goslar
Country
Germany
Facility Name
Universitätsmedizin Greifswald, Medizinische Universitätsklinik C, Hämatologie und Onkologie
City
Greifswald
Country
Germany
Facility Name
Kreiskrankenhaus Gummersbach
City
Gummersbach
Country
Germany
Facility Name
Universitätsmedizin Göttingen, Hämatologie und Onkologie
City
Göttingen
Country
Germany
Facility Name
Klinikum Gütersloh
City
Gütersloh
Country
Germany
Facility Name
Kath. Krankenhaus Hagen, St.-Marien-Hospital
City
Hagen
Country
Germany
Facility Name
Gemeinschaftspraxis Rohrberg, Hurtz, Schmidt, Frank-Gleich
City
Halle (Saale)
Country
Germany
Facility Name
Asklepios Klinik St. Georg, Hämatologie/Onkologie
City
Hamburg
Country
Germany
Facility Name
Hämatolog.-onkolog. Praxis Dres. Müller-Hagen, Bertram, Albertinen-Krankenhaus
City
Hamburg
Country
Germany
Facility Name
Hämatologisch-onkologische Praxis Altona (HOPA)
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik und Poliklinik, Onkologie und Hämatologie
City
Hamburg
Country
Germany
Facility Name
Klinikum Hannover-Siloah, Klinik für Hämatologie
City
Hannover
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH), Zentrum für Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
City
Hannover
Country
Germany
Facility Name
Praxis MediProjekt
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Heidelberg, Innere Medizin V
City
Heidelberg
Country
Germany
Facility Name
Klinikum Kreis Herford, Med. Klinik II
City
Herford
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Dres. Freier, Sievers
City
Hildesheim
Country
Germany
Facility Name
St. Bernward Krankenhaus Hildesheim, Med. Klinik II
City
Hildesheim
Country
Germany
Facility Name
KMT Klinik Idar-Oberstein
City
Idar-Oberstein
Country
Germany
Facility Name
Universitätsklinikum Jena, Klinik für Innere Medizin II
City
Jena
Country
Germany
Facility Name
Westpfalz-Klinikum, Klinik für Innere Medizin I
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Praxis Dres Hansen, Reeb
City
Kaiserslautern
Country
Germany
Facility Name
St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2
City
Karlsruhe
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe, II. Med. Klinik, Hämatologie/Onkologie/Infektionskrankheiten
City
Karlsruhe
Country
Germany
Facility Name
GMP Dres Siehl, Söling
City
Kassel
Country
Germany
Facility Name
Rotes Kreuz Krankenhaus Kassel, Klinik für Interdisziplinäre Onkologie
City
Kassel
Country
Germany
Facility Name
Klinikum Kempten-Oberallgäu, Hämatologie, Onkologie und Palliativmedizin
City
Kempten
Country
Germany
Facility Name
Gemeinschaftsklinikum Mittelrhein, Ev. Stift St. Martin, Innere Medizin
City
Koblenz
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Neise, Lollert
City
Krefeld
Country
Germany
Facility Name
Praxis Dr. Strauch
City
Kronach
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Schmitz, Steinmetz, Severin
City
Köln
Country
Germany
Facility Name
Klinikum der Universität zu Köln, Klinik I für Innere Medizin
City
Köln
Country
Germany
Facility Name
Krankenhaus Holweide
City
Köln
Country
Germany
Facility Name
Klinikum Landshut, Med. Klinik I
City
Landshut
Country
Germany
Facility Name
Caritas Krankenhaus Lebach
City
Lebach
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Leer
Country
Germany
Facility Name
Klinikum St. Georg Leipzig, Abteilung für internistische Onkologie/Hämatologie
City
Leipzig
Country
Germany
Facility Name
Klinikum Lippe-Lemgo, Med. Klinik II
City
Lemgo
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Lörrach
City
Lörrach
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
Country
Germany
Facility Name
Klinikum Magdeburg, Hämatologie/Onkologie
City
Magdeburg
Country
Germany
Facility Name
Universitätsmedizin Mainz, III. Med. Klinik und Poliklinik
City
Mainz
Country
Germany
Facility Name
Mannheimer Onkologie Praxis, Dres. Brust, Plöger, Schuster, Hensel
City
Mannheim
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg
City
Marburg
Country
Germany
Facility Name
Johannes Wesling Klinikum, Klinik für Hämatologie, Onkologie und Palliativmedizin
City
Minden
Country
Germany
Facility Name
Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin
City
Mutlangen
Country
Germany
Facility Name
Kliniken Maria-Hilf Mönchengladbach, Innere Medizin I
City
Mönchengladbach
Country
Germany
Facility Name
GMP Dres Schröder/Sieg
City
Mülheim an der Ruhr
Country
Germany
Facility Name
Praxis Dres. Schmidt, Fromm, Wiesmeier, Seufert, Klapthor, Zingerle
City
München Pasing
Country
Germany
Facility Name
Klinikum Großhadern, Med. Klinik 3
City
München
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München, III. Med.Klinik
City
München
Country
Germany
Facility Name
Städtisches Klinikum München Harlaching
City
München
Country
Germany
Facility Name
Universitätsklinikum Münster, Med. Klinik A
City
Münster
Country
Germany
Facility Name
Onkologische Praxis Dr. Ladda
City
Neumarkt
Country
Germany
Facility Name
Lukaskrankenhaus Neuss, Med. Klinik II
City
Neuss
Country
Germany
Facility Name
Kreiskliniken Esslingen, Klinikum Kirchheim-Nürtingen, Hämatologie, Internist. Onkologie und Palliativmedizin
City
Nürtingen
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Balló, Böck
City
Offenbach
Country
Germany
Facility Name
Ortenau Klinikum Offenburg-Gegenbach, Medizinische Klinik II
City
Offenburg
Country
Germany
Facility Name
Klinikum Oldenburg, Hämatologie/Onkologie
City
Oldenburg
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Dr. Hübner
City
Oldenburg
Country
Germany
Facility Name
Pius Hospital Oldenburg, Klinik für Strahlentherapie und Internistische Onkologie
City
Oldenburg
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis im MVZ 2 GmbH, Dr. H. Eimermacher
City
Olpe
Country
Germany
Facility Name
Klinikum Osnabrück, Med. Klinik III
City
Osnabrück
Country
Germany
Facility Name
Paracelsus Krankenhaus Ruit, Kreiskliniken Esslingen gGmbH, Zentrum für Allgemeine Innere Medizin
City
Ostfildern
Country
Germany
Facility Name
Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie
City
Paderborn
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Baake, Leonhardt, Moegling, am Regio Klinikum Pinneberg
City
Pinneberg
Country
Germany
Facility Name
Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin
City
Potsdam
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Decker, Nonnenbroich, Herbrik-Zipp
City
Ravensburg
Country
Germany
Facility Name
Prosper-Hospital Recklinghausen, Med. Klinik I
City
Recklinghausen
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
City
Regensburg
Country
Germany
Facility Name
Klinikum am Steinenberg, Kreiskliniken Reutlingen GmbH
City
Reutlingen
Country
Germany
Facility Name
Elblandklinikum Riesa, Klinik für Innere Medizin II
City
Riesa
Country
Germany
Facility Name
Klinikum Südstadt Rostock, Innere Medizin
City
Rostock
Country
Germany
Facility Name
Universitätsklinikum Rostock, Abteilung Hämatologie/Onkologie, Klinik u. Poliklinik für Innere Medizin
City
Rostock
Country
Germany
Facility Name
GMP Dres Jacobs, Daus, Schmits
City
Saarbrücken
Country
Germany
Facility Name
ZAHO-Siegburg, Zentrum für ambulante Hämatologie und Onkologie Siegburg
City
Siegburg
Country
Germany
Facility Name
Diakonie-Klinikum Stuttgart, Med. Klinik II
City
Stuttgart
Country
Germany
Facility Name
Klinikum Traunstein, Hämatologie/Onkologie
City
Traunstein
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I
City
Trier
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder Trier, I. Med. Abteilung
City
Trier
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Medizinische Klinik und Poliklinik, Onkologie, Hämatologie, Immunologie und Rheumatologie
City
Tübingen
Country
Germany
Facility Name
Universitätsklinikum Ulm, Innere Medizin III
City
Ulm
Country
Germany
Facility Name
Katharinen Hospital Unna
City
Unna
Country
Germany
Facility Name
Schwarzwald-Baar-Klinikum - Innere Medizin II
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Praxis Onkologie Schwarzwald - Alb
City
Villingen-Schwenningen
Country
Germany
Facility Name
Med. Versorgungszentrum Weiden, Abteilung für Onkologie
City
Weiden
Country
Germany
Facility Name
Praxis Dres med. Perker, Sandherr
City
Weilheim
Country
Germany
Facility Name
HSK Wiesbaden, Innere Medizin III
City
Wiesbaden
Country
Germany
Facility Name
Helios Klinkum Wuppertal, Med. Klinik I
City
Wuppertal
Country
Germany
Facility Name
Hämatologisch-Onkologische Praxis Würselen
City
Würselen
Country
Germany

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
PubMed Identifier
33928400
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.
Results Reference
derived

Learn more about this trial

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

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