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

• Status: Active, not recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universität des Saarlandes; University Hospital, Saarland
• Collaborators: German High-Grade Non-Hodgkin's Lymphoma Study Group; Spectrum Pharmaceuticals, Inc
• Treatments: Rituximab; Vincristine; Vitamin D

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.