Clinical trial · Interventional
A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL
A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL - REACH
NCT04279938CI-TRIAL-00043574withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Safety data on drug
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Diffuse Large B-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Tinostamustinein | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Safety Run in & Main Efficacy Part
- description
- Part 1 (safety run-in) aims to evaluate the maximum tolerated dose (MTD) of tinostamustinein combination with pembrolizumab (200mg Q3W) and rituximab (375mg/m2 Q3W). The dose of tinostamustineestablished to be safe and tolerable in this combination will be used in part 2 of the trial (main efficacy part). The aim of part 2 is to detect signals of anti-tumour activity and to further assess the safety of this combination treatment in r/r DLBCL. The study has a strong focus on correlative research in order to identify mechanisms of response and resistance to pembrolizumab and the pembrolizumab/R-tinostamustinecombination.
- interventionNames
- Drug: Tinostamustinein
- Drug: Pembrolizumab
- Drug: Rituximab
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 2.3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.