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Clinical Trials/EUCTR2014-004689-11-GB
EUCTR2014-004689-11-GB
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

MorphoSys AG0 sites330 target enrollmentOctober 17, 2016
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ConditionsRelapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)MedDRA version: 20.0 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsMabThera (500 mg)Levact (100 mg)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Sponsor
MorphoSys AG
Enrollment
330
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2016
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

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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