Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hod… (NCT03302728) | Clinical Trial Compass
CompletedPhase 1
Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma
Australia6 participantsStarted 2018-08-30
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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.
Exclusion criteria
. 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).
. 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.