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Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma

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

NCT03046953•University of Birmingham

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 refractory 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 refractory 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 receive up to 8 cycles of avelumab treatment. Avelumab is an anti-PDL1 (programmed cell death receptor ligand 1) 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 avelumab, by measuring 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.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients aged ≥ 16 years
•Life expectancy \> 12 weeks
•ECOG (eastern oncology cooperative group) 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 (natural killer)/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:
+7 more criteria

Exclusion Criteria

•All patients with active central nervous system (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 deteriorate 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
+8 more criteria

Locations (1)

University College London Hospital

London, United Kingdom

Key Dates

Start Date

December 8, 2017

Primary Completion Date

July 31, 2020

Completion Date

July 27, 2021

Last Updated

July 16, 2024

Enrollment

ACTUAL participants

Conditions

T-Cell Lymphoma RelapsedT-Cell Lymphoma Refractory

Interventions

Avelumab

DRUG

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T-Cell Lymphoma RelapsedAdult T-Cell Leukemia (ATL)+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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