Lymphoma, T-Cell, CutaneousPhase 1EpiBrentlenNCT03302728

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

A Phase 1 study testing Lenalidomide 15mg and Brentuximab Vedotin 1.8 mg/Kg in people with Lymphoma, T-Cell, Cutaneous and Lymphoma, T-Cell, Peripheral, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Hodgkin Lymphoma
What is being tested?: Lenalidomide 15mg and Brentuximab Vedotin 1.8 mg/Kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteAustralia
Study dates: 30 Aug 2018to 2 Aug 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients of 18 years or older.
Patient must have a diagnosis of a CD30+ Hodgkin Lymphoma or CD30+ peripheral T-cell lymphoma. Patients with either Hodgkin lymphoma or T-cell lymphoma must have expression of CD30 in ≥10% of lymphoma cells. Patients with CTCL will be considered for inclusion even if CD30 immunohistochemical staining with BerH2 antibody is low or negligible (<10%).
Peripheral T-cell lymphoma: patients must be considered relapsed or refractory after at least one prior chemotherapeutic regimen or be considered by the investigator to be not suitable for chemotherapy
Cutaneous T-cell lymphoma: patients must be relapsed or refractory to one prior systemic therapy or be considered by the investigator to be not suitable for chemotherapy
Patients with Hodgkin lymphoma and one of the following:
Relapsed or refractory after at least 2 prior chemotherapy-containing regimens ii.Considered unsuitable for chemotherapy

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Voluntary written informed consent must be given before performance of any study- related procedure.
Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
Performance status of ECOG ≤2.
Clinical laboratory values as specified below. Blood tests must be within 10 days of patient registration:
Absolute neutrophil count >1.5 x109/L, or >1.0 x109/L in the setting of known marrow involvement by tumour.
Platelet count ≥75x109/L.
Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome.
ALT or AST must be < 2.5 x the upper limit of the normal range. AST or ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of haematologic/solid tumor in liver.
Serum creatinine must be < 150 µmol/L and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
Haemoglobin must be ≥ 80g/L.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy (except alopecia) prior to registration.

Who cannot join

Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on planned cycle 1, day 1 prior to first dose of study drug.
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
Symptomatic neurologic disease compromising normal activities of daily living or requiring medication/s, including signs or symptoms of Progressive Multifocal Leucoencephalopathy (PML).
Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 at registration.
Known history of any of the following cardiovascular conditions
New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 18.1).

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Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
A left-ventricular ejection fraction <50%
Any active systemic viral, bacterial, or fungal infection requiring systemic intravenous antibiotics or systemic antifungal therapies within 2 weeks prior to registration.
Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment.
Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or lenalidomide.
Known human immunodeficiency virus (HIV) positive.
Known hepatitis B surface antigen (HBsAg)-positive, or known or suspected active hepatitis C infection. Patients who are Hepatitis B core antibody positive with no evidence of active disease, i.e.
HBsAg negative/ negative hepatitis B viral load, will still be considered eligible for inclusion, but must receive viral suppressive therapy for the duration of the trial.
Active systemic malignancy likely to require treatment within the next two years, or previous diagnosis of another malignancy with residual disease. Patients with non-melanoma skin cancer or carcinoma- in-situ of any type are not excluded if they have undergone complete resection.
Previous exposure to brentuximab vedotin.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000

Other trials in Australia

About this study

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

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.

Conditions: Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Hodgkin Lymphoma
Being tested: Lenalidomide 15mg, Brentuximab Vedotin 1.8 mg/Kg
Keywords: CD 30 positive, relapsed, refractory
Medical subject headings: Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Hodgkin Disease, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lenalidomide 15mgDrug
Also called Revlimid
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
Brentuximab Vedotin 1.8 mg/KgDrug
Also called Adcetris
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

Study groups in NCT03302728
Study group	Role	What they receive
Lenalidomide & brentuximab vedotin	Experimental	Brentuximab vedotin 1.8mg/Kg Lenalidomide 15 mg Receives: Drug: Lenalidomide 15mg; Drug: Brentuximab Vedotin 1.8 mg/Kg

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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%.
Measured: 70 weeks

Secondary outcomes (6)

Safety profile of the combination of lenalidomide and brentuximab vedotin
Toxicities measured using CTCAE V4.03.
Measured: 70 weeks
Treatment intensity.
Treatment intensity defined as the actual total dose received divided by the actual treatment period.
Measured: 48 weeks
Objective response rate
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).
Measured: 70 weeks
Cytostatic response.
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).
Measured: 70 weeks
Event free survival.
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.
Measured: 70 weeks
Overall survival
Overall survival (OS), defined as the time from commencement of treatment to the date of death from any cause.
Measured: 70 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 20182 Aug 2021

First posted5 Oct 2017
Study start30 Aug 2018
Primary completion2 Aug 2021
Study completion2 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03302728
Sponsor's protocol ID: 17/34
Acronym: EpiBrentlen
Status last verified: May 2022
First submitted: 1 Oct 2017
Last updated: 19 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lymphoma, T-Cell, Cutaneous trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03302728
Acronym / sponsor ID: EpiBrentlen / 17/34
Conditions: Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Hodgkin Lymphoma
Keywords: CD 30 positive, relapsed, refractory
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
Study start: 30 Aug 2018 (actual)
Primary completion: 2 Aug 2021 (actual)
Study completion: 2 Aug 2021 (actual)
First posted: 5 Oct 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Lenalidomide & brentuximab vedotin	Experimental	Drug: Lenalidomide 15mg, Drug: Brentuximab Vedotin 1.8 mg/KgBrentuximab vedotin 1.8mg/Kg Lenalidomide 15 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Male or female patients of 18 years or older.
Patient must have a diagnosis of a CD30+ Hodgkin Lymphoma or CD30+ peripheral T-cell lymphoma. Patients with either Hodgkin lymphoma or T-cell lymphoma must have expression of CD30 in ≥10% of lymphoma cells. Patients with CTCL will be considered for inclusion even if CD30 immunohistochemical staining with BerH2 antibody is low or negligible (<10%).
Voluntary written informed consent must be given before performance of any study- related procedure.
Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.

Key exclusion criteria (16 listed)

Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on planned cycle 1, day 1 prior to first dose of study drug.
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
Symptomatic neurologic disease compromising normal activities of daily living or requiring medication/s, including signs or symptoms of Progressive Multifocal Leucoencephalopathy (PML).
Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 at registration.
Known history of any of the following cardiovascular conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lenalidomide 15mgAlso: RevlimidAt 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	Drug	Lenalidomide & brentuximab vedotin
Brentuximab Vedotin 1.8 mg/KgAlso: AdcetrisAt 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	Drug	Lenalidomide & brentuximab vedotin

Primary outcome

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%.

6 secondary outcomes

Safety profile of the combination of lenalidomide and brentuximab vedotin
Time frame: 70 weeks
Treatment intensity.
Time frame: 48 weeks
Objective response rate
Time frame: 70 weeks
Cytostatic response.
Time frame: 70 weeks
Event free survival.
Time frame: 70 weeks
Overall survival
Time frame: 70 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Dickinson, Dr principal investigator

Peter MacCallum Cancer Centre, Australia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03302728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.