Safety & Efficacy of Lenalidomide with MOR00208 in R-R DLBCL Patients
Research type
Research Study
Full title
A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
IRAS ID
181045
Contact name
Nagesh Kalakonda
Contact email
Sponsor organisation
MorphoSys AG
Eudract number
2014-004688-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 114,856
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
The number of new cases of diffuse large B-cell lymphoma (DLBCL) continues to increase. Despite advances in first-line treatment, rituximab plus standard CHOP chemotherapy, 30–40% of such patients relapse. A substantial percentage of patients will either fail to respond to second-line salvage therapy or its use may not be appropriate for those with comorbidities or advanced age. Rational combinations of effective compounds often lead to better clinical outcomes in DLBCL than single-agent therapy.
MOR00208 is an antibody that is made in the laboratory and is expected to bind and help fight against cancerous B lymphocytes in the body. Lenalidomide (LEN; Revlimid®) affects the immune system and helps promote immune responses to prevent inflammation in the body. This phase II, open-label, single-arm, study aims to determine if MOR00208 in combination with LEN is safe and effective in adults with DLBCL who have relapsed after or are not responding to treatment with at least one, but no more than two, previous systemic therapies.
Part 1 (6 patients; first 28 day cycle of treatment) is to decide the LEN safest dose for Part 2. In Part 2, patients will receive MOR00208 infusions every 7 days of a 28-day cycle for 3 cycles, then every 14 days. MOR00208 with LEN may be received for up to 12 months, MOR00208 (without LEN) for up to an additional 12 months. Participants could be in the trial for up to 3 years and undergo several procedures, including blood, and urine sampling, CT and PET scans throughout the study. A tumour tissue sample is required if one taken within 3 years is not available. A mucosal cheek swab for genotyping is optional.
The study will include approximately 80 patients in Europe and United States. The study is sponsored by a pharmaceutical company.
REC name
West of Scotland REC 1
REC reference
15/WS/0184
Date of REC Opinion
9 Sep 2015
REC opinion
Unfavourable Opinion