Relapsed or Refractory Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL - REACH
Verified date | February 2020 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Safety run-in (part 1): Relapsed or refractory B-cell Non-Hodgkin lymphoma (NHL)
Main study (part 2): Relapsed or refractory diffuse large B-cell lymphoma
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2021 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically proven CD20+ DLBCL (including transformed lymphoma) - Previous treatment with at least 1 line of standard therapy - Age 18 or over - ECOG performance status 0/1 Measurable disease on cross-sectional imaging that is at least 1.5 cm in the longest diameter and measureable in two perpendicular dimensions - Adequate organ function - Resolution of prior systemic therapy related non-haematological AEs to grade (G) = 1. Participants with = G 2 neuropathy may be eligible. - Consent to provide fresh tumour tissue during screening and treatment Exclusion Criteria: - CNS or leptomeningeal involvement - Autologous stem cell transplant (ASCT) within 12 weeks or other anticancer treatment within 3 weeks of commencing therapy - Prior allogeneic transplant - Known HIV, or active Hepatitis B/C infection - Active systemic autoimmune disease - No previous therapy with agents targeting immune checkpoint proteins |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | Surrey |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust | Merck Sharp & Dohme Corp., Mundipharma-EDO GmbH |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Part 1 (safety run-in): To assess the safety and tolerability of pembrolizumab in combination with R-tinostamustineand to recommend a safe and tolerated dose of tinostamustinefor use in part 2 in combination with 200mg pembrolizumab and 375mg/m2 rituximab . Part 2 (main study): To assess efficacy of pembrolizumab in combination with R-tinostamustineas determined by best overall response in subjects with relapsed/refractory (r/r) DLBCL. |
2.3 years | |
Secondary | Secondary Objectives | Anti-tumour activity of pembrolizumab in combination with R-tinostamustineas determined by complete response rate (CR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS) To assess the safety profile of pembrolizumab in combination with R-tinostamustinein subjects with r/r DLBCL Exploratory biomarkers of response and resistance to pembrolizumab in combination with R-tinostamustine |
2.3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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