Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma

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Brief Title

Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma

Official Title

A Phase 2a Trial of Avelumab, an Anti-PDL1 Antibody, in Relapsed and Refractory Peripheral T-cell Lymphoma

Brief Summary

      The AVAIL-T trial is a trial to find out how effective avelumab is at treating patients with
      primary T-cell lymphoma that is refratory to or has relapsed following initial treatment.
    

Detailed Description

      The AVAIL-T trial is designed to find out how effective avelumab is at treating patients with
      primary T-cell lymphoma that is refratory to or has relapsed following initial treatment. Up
      to 36 people will be taking part in the AVAIL-T trial at hospitals across the United Kingdom.
      All patients on the trial will be recruited over 2 years and recieve up to 8 cycles of
      avelumab treatment. Avelumab is an anti-PD-L1 antibody that will be given as an infusion once
      every 2 weeks in cycles lasting 28 days. The trial will be looking at the response to
      aveulumab, by mesuring the change in the tumour size using CT scans, and seeing how long that
      response is maintained. The trial will also look at toxicity, overall survival, and
      progression free survival.

      In addition we will analyse blood samples and samples of the cancer to understand better how
      the cancer behaves. This may guide the investigators in developing better treatments in the
      future.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Best overall resposne rate during the first 8 cycles of treatment

Secondary Outcome

 Toxicity- Number of Patients

Condition

T-Cell Lymphoma Relapsed

Intervention

Avelumab

Study Arms / Comparison Groups

 Avleumab
Description:  Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

34

Start Date

November 14, 2017

Completion Date

July 27, 2021

Primary Completion Date

July 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female patients aged ≥ 16 years

          -  Life expectancy > 12 weeks

          -  ECOG performance status ≤ 2

          -  Relapsed or refractory* peripheral T-cell lymphoma including the following
             histologies: peripheral T-cell lymphoma not otherwise specified (PTCL NOS) ,
             angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL),
             enteropathy associated T-cell lymphoma (EATL), extranodal NK/T- cell lymphoma (ENKL),
             transformed mycosis fungoides (LCT MF), hepatosplenic T-cell lymphoma (HSTCL) * For
             all relapsed patients, relapse must be confirmed by tissue biopsy (or bone marrow
             trephine if no other tissue available). For refractory patients, a biopsy must have
             been obtained within the last 3 months

          -  Failed at least 1 prior therapy (but no upper limit of prior regimens)

          -  Adequate haematological function defined by at registration:

               -  absolute neutrophil count (ANC) ≥ 1.0 × 109/L, (unsupported)

               -  platelet count ≥ 75 × 109/L, (unsupported)

               -  haemoglobin ≥ 9 g/dL (may have been transfused)

          -  Adequate hepatic function defined by:

               -  total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range

               -  AST or ALT levels ≤ 2.5 × ULN for all patients or AST and ALT levels ≤ 5 x ULN
                  (for subjects with documented metastatic disease to the liver)

          -  Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min
             according to the Cockcroft-Gault formula (or local institutional standard method)

          -  CT measurable disease with at least 1 lesion having short axis > 1.5cm or splenomegaly
             > 14cm in cranio-caudal length attributable to relapsed/non responding lymphoma

          -  Negative serum pregnancy test at screening for women of childbearing potential.

          -  Highly effective contraception for both male and female patients if the risk of
             conception exists. (Note: women of childbearing potential and men able to father a
             child must agree to use 2 highly effective contraception, defined as methods with a
             failure rate of less than 1 % per year. Highly effective contraception is required
             from consent, throughout and for at least 60 days after avelumab treatment.

          -  Ability to give informed consent

        Exclusion Criteria:

        Patients are not eligible for the trial if they fulfill any of the following exclusion
        criteria:

          -  All patients with active CNS involvement of lymphoma

          -  Prior organ transplantation, including allogeneic stem cell transplantation

          -  Significant acute or chronic infections including, among others:

               -  Known history of testing positive test for human immunodeficiency virus (HIV) or
                  known acquired immunodeficiency syndrome (AIDS),

               -  Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
                  (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test
                  positive)

          -  Current use of immunosuppressive medication, EXCEPT for the following:

               -  intranasal, inhaled, topical steroids, or local steroid injection (e.g.,
                  intra-articular injection); Systemic corticosteroids at a maximum dose of ≤ 1
                  mg/kg of prednisone or equivalent during screening (to be stopped by day 1 of
                  trial treatment); Steroids as premedication for hypersensitivity reactions (e.g.,
                  CT scan premedication).

          -  Active autoimmune disease that might deteriorat e when receiving an immunostimulatory
             agent. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
             disease not requiring immunosuppressive treatment are eligible

          -  Known prior severe hypersensitivity to investigational product or any component in its
             formulations, including known severe hypersensitivity reactions to monoclonal
             antibodies (NCI CTCAE v4.03 Grade ≥ 3)

          -  Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however,
             alopecia and sensory neuropathy Grade ≤ 2 or other Grade ≤ 2 not constituting a safety
             risk based on investigator's judgment are acceptable are acceptable

          -  Pregnancy or lactation

          -  Known alcohol or drug abuse

          -  Clinically significant (i.e., active) cardiovascular disease: cerebral vascular
             accident/stroke (< 6 months prior to registration), myocardial infarction (< 6 months
             prior to registration), unstable angina, congestive heart failure (≥ New York Heart
             Association Classification Class II), or serious cardiac arrhythmia requiring
             medication.

          -  Other severe acute or chronic medical conditions including colitis, inflammatory bowel
             disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent
             (within the past year) or active suicidal ideation or behaviour; or laboratory
             abnormalities that may increase the risk associated with study participation or study
             treatment administration or may interfere with the interpretation of study results
             and, in the judgment of the investigator, would make the patient inappropriate for
             entry into this study

          -  Vaccination within 4 weeks of the first dose of avelumab and while on trial is
             prohibited except for administration of inactivated vaccines

          -  Active infection requiring systemic therapy

          -  Major surgery within 4 weeks of trial entry

          -  Patients and partners of childbearing potential not willing to use two methods of
             effective contraception during and for 60 days after therapy
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Simon Wagner, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03046953

Organization ID

RG_16-123


Responsible Party

Sponsor

Study Sponsor

University of Birmingham

Collaborators

 Bloodwise

Study Sponsor

Simon Wagner, MD, Principal Investigator, Univeristy of Leicester


Verification Date

October 2021