NCT03302728: EpiBrentlen

Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma

Completed Phase 1 Last updated 19 May 2022

What this trial tests

Phase 1 trial testing Lenalidomide 15mg in Lymphoma, T-Cell, Cutaneous in 6 participants. Completed in 2 August 2021.

Timeline

30 August 2018

Primary endpoint
2 August 2021

2 August 2021

Quick facts

Lead sponsor	Peter MacCallum Cancer Centre, Australia
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	30 August 2018
Primary completion	2 August 2021
Estimated completion	2 August 2021
Sites	1 location across Australia

Drugs / interventions tested

• Lenalidomide 15mg — full drug profile →
• Brentuximab Vedotin 1.8 mg/Kg — full drug profile →

Conditions studied

• Lymphoma, T-Cell, Cutaneous — all drugs for Lymphoma, T-Cell, Cutaneous →
• Lymphoma, T-Cell, Peripheral — all drugs for Lymphoma, T-Cell, Peripheral →
• Hodgkin Lymphoma — all drugs for Hodgkin Lymphoma →

Sponsor

Peter MacCallum Cancer Centre, Australia — full company profile →

Who can join

18 and older, any sex, with Lymphoma, T-Cell, Cutaneous or Lymphoma, T-Cell, Peripheral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is investigating the combination of Brentuximab vedotin and lenalidomide in the treatment of relapsed/refractory peripheral T cell lymphoma or cutaneous T cell lymphoma or Hodgkin lymphoma.

It is hypothesised that lenalidomide may augment the actions of Brentuximab vedotin in these patient groups. The primary objective of the study is to determine the maximum tolerated dose of the combination treatment, which can be used in subsequent studies. The study will also investigate disease response and survival.

Participants will receive Brentuximab vedotin (once every 21 days i.e. 1 cycle) and lenalidomide (daily from day 1 -14 of each cycle) for a maximum of 48 weeks and will be followed for a subsequent 6 months after the end of treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The changing therapeutic landscape, burden of disease, and unmet needs in patients with cutaneous T-cell lymphoma.
   Scarisbrick JJ, Bagot M, Ortiz-Romero PL. · · 2021 · cited 29× · PMID 33095448 · DOI 10.1111/bjh.17117
2. Targeted Drug Delivery and Theranostic Strategies in Malignant Lymphomas.
   Etrych T, Braunova A, Zogala D, Lambert L, et al · · 2022 · cited 17× · PMID 35158894 · DOI 10.3390/cancers14030626
3. Current Immunotherapy Approaches in Non-Hodgkin Lymphomas.
   Pytlik R, Polgarova K, Karolova J, Klener P. · · 2020 · cited 14× · PMID 33260966 · DOI 10.3390/vaccines8040708
4. Retrospective Analysis of 118 Patients With Cutaneous T-Cell Lymphomas: A Single-Center Experience.
   Polgárová K, Polívka J, Kodet O, Klener P, et al · · 2022 · cited 5× · PMID 35747818 · DOI 10.3389/fonc.2022.884091
5. Molecularly targeted therapies for relapsed and refractory peripheral T-cell lymphomas.
   Epstein-Peterson ZD, Horwitz SM. · · 2021 · cited 4× · PMID 33906725 · DOI 10.1053/j.seminhematol.2021.02.004
6. Current advances in Hodgkin's lymphoma.
   Vadakara J, Andrick B. · · 2019 · cited 4× · PMID 30993260 · DOI 10.1016/j.cdtm.2019.02.003
7. Low dose continuous lenalidomide in heavily pretreated patients with relapsed or refractory classical Hodgkin lymphoma: a retrospective case series.
   Ma H, Cheng B, Montanari F, Lue JK, et al · · 2020 · cited 3× · PMID 33062232 · DOI 10.1177/2040620720947340
8. Personalized Immunotherapy for T Cell Lymphomas: From Immune Escape to Precision Therapeutics.
   Casan JML, Ong XJ, van der Weyden C, Yannakou CK, et al · · 2025 · cited 1× · PMID 41295262 · DOI 10.3390/jpm15110560