EUCTR2014-004689-11-RO
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
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis/Trial Population
- •1\. Age \=18 years
- •2\. Histologically confirmed diagnosis of diffuse large B\-cell lymphoma not otherwise specified (DLBCL NOS); T cell/histiocyte rich large B\-cell lymphoma (THRLBCL), Epstein\-Barr virus (EBV) positive DLBCL of the elderly (EBV\-positive DLBCL) according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Patients with evidence of histological transformation to DLBCL from indolent NHL are also eligible.
- •3\. Recent tumour tissue for central pathology review and correlative studies must be provided. The only exception is the availability of tumour tissue acquired \=3 years prior to Screening.
- •4\. Patients must have:
- •a) R\-R DLBCL
- •b) at least one bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of \=1\.5 cm and greatest perpendicular diameter of \=1\.0 cm at baseline. The lesion must be positive on PET scan.
- •c) received at least one, but no more than three previous systemic therapy lines for the treatment of DLBCL and at least one therapy line must have included a CD20\-targeted therapy (e.g. RTX)
- •d) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •5\. Patients after failure of ASCT or patients considered in the opinion of the investigator not eligible for salvage therapy including ASCT. Documentation of the reason for ineligibility for ASCT must be present in the patient’s source data.
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 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
Outcomes
Primary Outcomes
Not specified
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