EUCTR2014-004689-11-CZ
Active, not recruiting
Phase 1
A Phase II/III, Randomised, Multicentre Study of MOR00208 with Bendamustine versus Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT) - B-MIND
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MorphoSys AG
- Enrollment
- 330
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis/Trial Population
- •1\. Age \=18 years
- •2\. Histologically confirmed diagnosis according to the World Health Organization (WHO, 2008\) classification of:
- •a) Diffuse large B\-cell lymphoma not otherwise specified (DLBCL NOS)
- •b) T cell/histiocyte rich large B\-cell lymphoma (THRLBCL)
- •c) Epstein\-Barr virus (EBV) positive DLBCL of the elderly (EBV\-positive DLBCL)
- •d) Composite lymphoma with a DLBCL component with a DLBCL relapse subsequent to DLBCL treatment
- •e) Disease transformed from an earlier diagnosis of low grade lymphoma (i.e. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with a DLBCL relapse subsequent to DLBCL treatment.
- •3\. Fresh tumour tissue for central pathology review must be provided as an adjunct to participation in this study. Should it not be possible to obtain a fresh tumour tissue sample, archival paraffin embedded tumour tissue acquired \=3 years prior to screening for this protocol must be available for this purpose.
- •4\. Patients must have:
Exclusion Criteria
- •Exclusionary Diagnosis Criteria
- •1\. Patients who have:
- •a) any other histological type of lymphoma including, e.g., primary mediastinal (thymic) large B\-cell (PMBL) or Burkitt’s lymphoma
- •b) primary refractory DLBCL
- •c) patients with known double/triple hit DLBCL genetics characterised by simultaneous detection of MYC with BCL2 and/or BCL6 translocation, as defined by fluorescence in situ hybridisation (FISH). MYC, BCL2, BCL6 testing prior to study enrolment is not required.
- •d) central nervous system (CNS) lymphoma involvement in present or past medical history
- •Exclusionary Previous and Current Treatment Criteria
- •2\. Patients who had a major surgery (for definition, see Section 8\.1\) less than 30 days prior to Day 1 dosing
- •3\. Patients who have, within 14 days prior to Day 1 dosing:
- •a) not discontinued CD20\-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma\-specific therapy (for exceptions see Section 9\.5\.3\)
Outcomes
Primary Outcomes
Not specified
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