An Evaluation AZD2014 Alone and in Combination With Rituximab in Relapsed/Refractory Diffuse Large B Cell Lymphoma

Sponsor
University of Birmingham
Study ID
NCT02752204
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD 2014 — DRUG
    AZD2014 125mg BD - 2 days on 5 days off in a 28 day cycle
  • Rituximab — DRUG
    Rituximab 375mg/m2 will be administered intravenously on day 1 of a 28 day cycle for a total of 6 cycles.

Study Details

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.

Key Dates

Start date
Oct 31, 2015
Status verified
Nov 2020
Primary completion
Sep 7, 2017
Completion
Feb 6, 2020

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Stage 1
    AZD 2014 oral tablets will be given to patients
  • Other: Stage 2
    AZD 2014 oral tablets and rituximab infusion will be given to patients

Primary Outcome Measure

Best overall response rate (PR plus CR) (using the Revised Response Criteria for Malignant Lymphoma ) during the first 6 cycles [ Time Frame: Data in relation to this outcome will be collected over the first 6 cycles of therapy - each cycle is 28 days in duration ]

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