Improvement of Therapy of Elderly Patients Witch CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine

This study is currently recruiting participants.
Verified December 2011 by University Hospital, Saarland

First Received on November 18, 2011.  
Last Updated on December 8, 2011  
History of Changes
This Clinical Trial Sponsored By: University Hospital, Saarland
Collaborators: Saarland University (Official Sponsor)
German High-Grade Non-Hodgkin’s Lymphoma Study Group
Information provided by (Responsible Party): University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01478542
 

Purpose for Clinical Trial

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 reducing the Immuno-Chemotherapy using FDG-PET after induction therapy.

Condition Study Intervention Clinical Trial Phase
B-Cell Lymphomas Drug: Conventional Vincristine
Drug: Liposomal Vincristine
Phase 3

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improvement of Outcome and Reduction of Toxicity in Elderly Patients With CD20 DLBCL by an Optimised Schedule of Rituximab, Substitution of Conventional by Liposomal Vincristine, and FDG-PET Based Reduction of Therapy.

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Vincristine sulfate
Rituximab

U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

Estimated Enrollment: 1152
Study Start Date: November 2011
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Active Comparator: Favourable Prognosis F-A Drug: Conventional Vincristine
Experimental: Favourable F-B Drug: Liposomal Vincristine
Active Comparator: Less Favourable LF-A Drug: Conventional Vincristine
Experimental: Less Favourable LF-B Drug: Liposomal Vincristine
Active Comparator: Less Favourable LF-C Drug: Conventional Vincristine
Experimental: Less Favourable LF-D Drug: Liposomal Vincristine

  Eligibility

Ages Eligible for Study:   61 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All risk groups (IPI 1-5)
  2. Diagnosis of aggressive CD20+.
  3. 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 (LBCL)
      • primary cutaneous DLBCL, leg type
      • EBV-pos. DLBCL of the elderly
    • DLBCL associated with chronic inflammation
    • primary mediastinal (thymic) LBCL
    • intravascular LBCL
    • ALK-positive LBCL
    • plasmoblastic lymphoma
    • primary effusion 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 (PT). The performance status of each patient must be assessed before the initiation and after the end of PT. The PT status must be documented in the Staging CRF; the performance status after the PT must also be documented in the respective PT CRF.
  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 PT cf. 8.7.2)
  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 (PT with prednisone/prednisolone!)
  3. Platelets <100 000/mm3, leukocytes <2500/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 basalioma of the skin and carcinoma in situ)
  13. CNS involvement of lymphoma (intracerebral, meningeal, intraspinal) or primary CNS lymphoma
  14. Persistent neuropathy grade ≥2 (NCI CTC-AE v4.03)
  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 un

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