Status:
COMPLETED
OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients with CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine
Lead Sponsor:
Universität des Saarlandes
Collaborating Sponsors:
German High-Grade Non-Hodgkin's Lymphoma Study Group
Spectrum Pharmaceuticals, Inc
Conditions:
CD20+ Aggressive B-Cell Lymphoma
Eligibility:
All Genders
61-80 years
Phase:
PHASE3
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 sched...
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 lipo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
1152 Patients enrolled
Trial Details
Trial ID
NCT01478542
Start Date
November 1 2011
End Date
January 18 2024
Last Update
January 8 2025
Active Locations (127)
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1
Saarland University Hospital
Homburg, Saarland, Germany, 66421
2
Evangelisches Krankenhaus Paul Gerhardt Stift, Klinik für Innere Medizin II
Wittenberg, Saxony-Anhalt, Germany, 06886
3
Klinik für Hämatologie und Onkologie
Aachen, Germany, 52074
4
Innklinikum Altötting
Altötting, Germany, 84503