NCT03302728
Completed
Phase 1
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
Peter MacCallum Cancer Centre, Australia1 site in 1 country6 target enrollmentAugust 30, 2018
Overview
- Phase
- Phase 1
- Intervention
- Lenalidomide 15mg
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Sponsor
- Peter MacCallum Cancer Centre, Australia
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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:
- •i. Relapsed or refractory after at least 2 prior chemotherapy-containing regimens ii.Considered unsuitable for chemotherapy
- •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 ≤
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.
- •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.
Arms & Interventions
Lenalidomide & brentuximab vedotin
Brentuximab vedotin 1.8mg/Kg Lenalidomide 15 mg
Intervention: Lenalidomide 15mg
Lenalidomide & brentuximab vedotin
Brentuximab vedotin 1.8mg/Kg Lenalidomide 15 mg
Intervention: Brentuximab Vedotin 1.8 mg/Kg
Outcomes
Primary Outcomes
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%.
Secondary Outcomes
- Overall survival(70 weeks)
- Safety profile of the combination of lenalidomide and brentuximab vedotin(70 weeks)
- Event free survival.(70 weeks)
- Treatment intensity.(48 weeks)
- Objective response rate(70 weeks)
- Cytostatic response.(70 weeks)
Study Sites (1)
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