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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03302728




Registration number
NCT03302728
Ethics application status
Date submitted
1/10/2017
Date registered
5/10/2017

Titles & IDs
Public title
Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma
Scientific 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
Secondary ID [1] 0 0
17/34
Universal Trial Number (UTN)
Trial acronym
EpiBrentlen
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, T-Cell, Cutaneous 0 0
Lymphoma, T-Cell, Peripheral 0 0
Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide 15mg
Treatment: Drugs - Brentuximab Vedotin 1.8 mg/Kg

Experimental: Lenalidomide & brentuximab vedotin - Brentuximab vedotin 1.8mg/Kg Lenalidomide 15 mg


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
70 weeks
Secondary outcome [1] 0 0
Safety profile of the combination of lenalidomide and brentuximab vedotin
Timepoint [1] 0 0
70 weeks
Secondary outcome [2] 0 0
Treatment intensity.
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Objective response rate
Timepoint [3] 0 0
70 weeks
Secondary outcome [4] 0 0
Cytostatic response.
Timepoint [4] 0 0
70 weeks
Secondary outcome [5] 0 0
Event free survival.
Timepoint [5] 0 0
70 weeks
Secondary outcome [6] 0 0
Overall survival
Timepoint [6] 0 0
70 weeks

Eligibility
Key inclusion criteria
1. Male or female patients of 18 years or older.
2. 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%).

1. 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
2. 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
3. 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
3. Voluntary written informed consent must be given before performance of any study- related procedure.
4. 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.
5. 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.
6. Performance status of ECOG =2.
7. 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.
8. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy (except alopecia) prior to registration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
2. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
3. Symptomatic neurologic disease compromising normal activities of daily living or requiring medication/s, including signs or symptoms of Progressive Multifocal Leucoencephalopathy (PML).
4. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 at registration.
5. Known history of any of the following cardiovascular conditions

1. New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 18.1).
2. 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.
3. A left-ventricular ejection fraction <50%
6. Any active systemic viral, bacterial, or fungal infection requiring systemic intravenous antibiotics or systemic antifungal therapies within 2 weeks prior to registration.
7. 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.
8. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or lenalidomide.
9. Known human immunodeficiency virus (HIV) positive.
10. 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.
11. 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.
12. Previous exposure to brentuximab vedotin.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2021
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Dickinson, Dr
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03302728