Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Diffuse Large B Cell Lymphoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 61 years and 80 years
Gender
Both males and females

Description

Cycle 1 (C1): At C1/day d2, there will be a CT- or ultrasound-guided re-biopsy of a lymphoma lesion that is accessible for biopsy without considerable risk for the patient. Cycle 2 (C2): After C2, a post-Interim CT will be performed (eventually FDG and FLT PET-CT imaging added to the protocol by ame...

Cycle 1 (C1): At C1/day d2, there will be a CT- or ultrasound-guided re-biopsy of a lymphoma lesion that is accessible for biopsy without considerable risk for the patient. Cycle 2 (C2): After C2, a post-Interim CT will be performed (eventually FDG and FLT PET-CT imaging added to the protocol by amendment). Cycle 3 (C3): At C3/d0 (prior to therapy), there will also be another bone marrow aspirate for MRD follow-up. At C3/d2, there will be a re-biopsy of a lymphoma site in case of a residual lesion by CT that is accessible for biopsy without considerable risk for the patient. Biopsies can be obtained CT- or ultrasound-guided. End of treatment/post-therapy: The end-of-treatment visit is required for all subjects, irrespective of a completion of all 8 cycles of therapy or exit of the study protocol. It has to be scheduled approximately 4 to 6 weeks after the last cycle. A total of 7 Follow up visits is planned over 30 months of follow up.

Tracking Information

NCT #
NCT03129828
Collaborators
  • Charite University, Berlin, Germany
  • Janssen-Cilag Ltd.
Investigators
Principal Investigator: Clemens Schmitt, Prof. Dr. Representative of the Sponsor, National Coordinator, Principal Investigator
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024