An Evaluation AZD2014 Alone and in Combination With Rituximab in Relapsed/Refractory Diffuse Large B Cell Lymphoma
NCT02752204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-11-05
Summary
The aim of this clinical trial is to see if the drug called AZD2014 is effective and safe to use to treat patients with relapsed or refractory Diffuse Large BCell Lymphoma (DLBCL). The trial will also be looking at combining the antibody (Rituximab) with the drug AZD2014 in a small number of patients to see if this can be done without increasing the toxicity. 36 patients will be recruited to the trial. 30 will receive AZD2014 alone and the remaining 6 will receive AZD2014 plus rituximab. AZD2014 will be given as a 125mg tablet that is to be taken twice a day for 2 days out of every 7 (i.e. on days 1 and 2 of every week). Rituximab will be given via IV infusion on day 1 of every 28 days (once every 4 weeks) for a maximum of 6 cycles.
Conditions
- Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
AZD 2014
AZD2014 125mg BD - 2 days on 5 days off in a 28 day cycle
- DRUG
-
Rituximab 375mg/m2 will be administered intravenously on day 1 of a 28 day cycle for a total of 6 cycles.
Sponsors & Collaborators
-
Bloodwise
collaborator OTHER - collaborator INDUSTRY
- collaborator OTHER
-
University of Birmingham
lead OTHER
Principal Investigators
-
Graham Collins, MBBS DPhil · The Churchill Hospital, Oxford, UK
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2017-09-07
- Completion
- 2020-02-06
Countries
- United Kingdom
Study Locations
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