Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma (EpiBrentlen)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03302728|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2017
Last Update Posted : October 10, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral Hodgkin Lymphoma||Drug: Lenalidomide 15mg Drug: Brentuximab Vedotin 1.8 mg/Kg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
This is a single arm dose escalation study. There are four dose levels for the combination of Brentuximab vedotin and Lenalidomide considered during the dose escalation.
Starting Dose Level 1: Brentuximab vedotin 1.8mg/kg q21 days & Lenalidomide 15 mg daily (D1-14)
The dose can be decreased as follows:
Level -2 Brentuximab vedotin 1.2mg/kg q21 days & Lenalidomide 5 mg daily (D1-14)
Level -1 Brentuximab vedotin 1.2mg/kg q21 days & Lenalidomide 10 mg daily (D1-14)
or the dose can be escalated as follows:
Level 2 Brentuximab vedotin 1.8mg/kg q21 days & Lenalidomide 25 mg daily (D1-14)
Patients will be assigned a starting dose by the safety committee; this will be communicated by the PI and/or their designated sub-investigator prior to planned Cycle1 Day 1 for each patient.
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory Cutaneous T-cell Lymphoma, CD30-positive Peripheral T-cell Lymphoma, or CD30-positive Hodgkin Lymphoma|
|Estimated Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||May 15, 2021|
|Estimated Study Completion Date :||August 15, 2021|
Experimental: Lenalidomide & brentuximab vedotin
Brentuximab vedotin 1.8mg/Kg Lenalidomide 15 mg
Drug: Lenalidomide 15mg
At commencement of study : Lenalidomide will commence at 15 mg daily for days 1-14 of each cycle. Maximum number of cycles = 16. This is a dose finding study so doses will be adjusted depending on toxicity assessment over the course of the study. Dose may vary from 5 mg -25 mg daily depending on dose escalation results and recommendation of safety committee
Other Name: Revlimid
Drug: Brentuximab Vedotin 1.8 mg/Kg
At commencement of study : Brentuximab vedotin 1.8mg/kg IV on day 1, repeated every 21 days. Maximum number of cycles = 16. This is a dose finding study so doses will be adjusted depending on toxicity assessment over the course of the study. Dose may be either 1.2 mg/Kg q21 days or 1.8 mg/kg q21 days depending on dose escalation results and recommendation of safety committee
Other Name: Adcetris
- Determination of the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of the combination of lenalidomide and brentuximab vedotin [ Time Frame: 70 weeks ]Maximum tolerated dose, dose-limiting toxicities of the combination therapy, and recommended phase 2 dose, in patients with relapsed/refractory cutaneous T-cell lymphoma, CD30-positive Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma. The MTD is defined as the highest dose level at which the incidence of DLT was less than 33%.
- Safety profile of the combination of lenalidomide and brentuximab vedotin [ Time Frame: 70 weeks ]Toxicities measured using CTCAE V4.03.
- Treatment intensity. [ Time Frame: 48 weeks ]Treatment intensity defined as the actual total dose received divided by the actual treatment period.
- Objective response rate [ Time Frame: 70 weeks ]Objective response, defined as achieving either complete response (CR) or partial response (PR) at some stage from time of commencement of treatment until conclusion of period of follow-up (maximum 16 cycles of treatment followed by 6 months of follow-up), or until time of documented progressive disease (defined as clinical and/or radiologic progression).
- Cytostatic response. [ Time Frame: 70 weeks ]Cytostatic response, defined as achieving complete response (CR), partial response (PR) or stable disease (SD) lasting >6 months from time of commencement of treatment until progressive disease (PD).
- Event free survival. [ Time Frame: 70 weeks ]Event free survival (EFS), defined as the time from commencement of treatment to date of early discontinuation of treatment due to toxicity, date of documented disease progression at any site, or date of death from any cause, whichever occurs first.
- Overall survival [ Time Frame: 70 weeks ]Overall survival (OS), defined as the time from commencement of treatment to the date of death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302728
|Contact: Carrie Van Der Weyden, Dr||+61385597588||Carrie.VanDerWeyden@petermac.org|
|Contact: Maria Farrell, Ms||+61386697533||Maria.Farrell@petermac.org|
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3000|
|Contact: Maria Farrell, Ms|
|Principal Investigator:||Michael Dickinson, Dr||Peter MacCallum Cancer Centre, Australia|