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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07913594




Registration number
Help: Registration number
NCT07913594
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
27/10/2026
Date registered
Help: Date registered
3/11/2026
Date last updated
Help: Date last updated
3/11/2026

Titles & IDs
Public title
Zilovertamab Vedotin and Lenalidomide (ZiVLen) Therapy for Relapsed/Refractory Peripheral T-Cell Lymphoma
Scientific title
Zilovertamab Vedotin and Lenalidomide (ZiVLen) Therapy for Relapsed/Refractory Peripheral T-Cell Lymphoma
Additional trial identifiers [1] 0 0
ONJ2025-004
Universal Trial Number (UTN)
Trial acronym
ZiVLen
Related trial records

Health condition
Health condition(s) studied:
Peripheral T-Cell Lymphoma Refractory 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Other - Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg
Treatment: Drugs - Lenalidomide

Experimental: Zilovertamab vedotin (1.75mg/kg) Q3W + Lenalidomide (15mg p.o. 14 days) - Induction phase:

Zilovertamab vedotin (1.75mg/kg) will be administered using a 30-minute IV infusion on Day 1 of Cycle 1, and then on Day 1 of each 3-week (21-day) cycle, for up to 6 cycles. Capsules of lenalidomide (15mg) will be administered orally (p.o) on planned dosing days (14 days per cycle) for up to 6 cycles.

Participants will have FDG PET/CT scans at the start of the study, prior to induction treatment and following cycle 2 and 6. Response assessments will be undertaken according to Lugano criteria. Participants achieving an objective response will continue onto maintenance phase.

Maintenance phase:

Lenalidomide treatment (15mg p.o, 14 days of a 21 day cycle) for up to 6 additional cycles.

After finishing treatment, participants will attend follow-up visits every 3 months for up to 24 months.


Treatment: Other: Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg
Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg will be administered every 3 weeks for 6 cycles

Treatment: Drugs: Lenalidomide
Lenalidomide (15mg) will be administered by mouth for 14 days of each 21 day cycle. 6 cycles will be administered in combination with zilovertamab vedotin, in participants with an objective response, a further 6 cycles will be administered (maximum of 12 cycles)
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Rate of complete response to up to 6 cycles of combination zilovertamab vedotin and lenalidomide
Timepoint [1] 0 0
Up to 18 weeks.
Secondary outcome [1] 0 0
Number of participants who experienced an adverse event (AE)
Timepoint [1] 0 0
Up to 110 days after the last dose of investigational product.
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
Up to 33 months
Secondary outcome [3] 0 0
Duration of response
Timepoint [3] 0 0
Up to 33 months
Secondary outcome [4] 0 0
Progression Free Survival
Timepoint [4] 0 0
Up to 33 months
Secondary outcome [5] 0 0
Change from baseline of health related quality of life
Timepoint [5] 0 0
Up to 9 months

Eligibility
Key inclusion criteria
1. Histologically confirmed R/R nodal PTCL which include subtypes T-follicular helper cell lymphoma (angioimmunoblastic T-cell lymphoma, follicular T-helper cell lymphoma, T-follicular helper cell lymphoma-not otherwise specified), anaplastic large cell lymphoma (ALCL; both ALK+ and ALK-) and peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS). In the absence of a fresh biopsy, the most recent archival tumour tissue should be used and obtained between the last dose of the last prior cancer regimen and C1D1.
2. Confirmed R/R disease after at least one prior line of therapy containing a combination chemotherapy regimen. Monotherapies, such as corticosteroids are excluded. Prior exposure to an ADC (including brentuximab vedotin) is permitted, provided all ADC-related toxicities, including but not limited to peripheral neuropathy, have resolved to Grade =1 prior to study entry.
3. Is an individual of any sex/gender, =18 years of age at the time of providing documented informed consent.
4. Patients of childbearing potential willing to adhere to the contraceptive precautions.
5. The participant (or legally acceptable representative) has provided documented informed consent for the study.

Additional Categories
6. Has an ECOG performance status of 0 to 1 (unless attributable to lymphoma, in which case patients of performance status 2 are eligible) assessed within 7 days before registration.
7. Has an ejection fraction =45% as determined by either ECHO or GCBP.
8. HIV infected participants must have well controlled HIV on ART.
9. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy and have undetectable HBV viral load prior to enrolment.

11. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.

12. Participants with a prior allogeneic haematopoietic stem cell transplant are eligible provided they are >90 days post-transplant, have no evidence of acute or chronic graft-versus-host disease, and are not receiving systemic immunosuppressive therapy (except for low-dose corticosteroids equivalent to <10 mg/day of prednisolone). Participants with a prior autologous haematopoietic stem cell transplant are eligible provided they are >90 days post-transplant and meet organ function and haematological parameter criteria unsupported by growth factors or transfusions.

13. Life expectancy > 12 weeks. 14. Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Any other type of lymphoma except nodal PTCL as listed above.
2. Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class =II), or serious cardiac arrhythmia requiring medication.
3. Has QTcF prolongation of >480 msec.
4. Has ongoing Grade >1 peripheral neuropathy.
5. Has a demyelinating form of Charcot-Marie-Tooth disease.
6. HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
7. Patients with a current or past history of venous thromboembolism (VTE; pulmonary embolism/deep venous thrombosis) are permitted to study inclusion provided that there is no contraindication to receive VTE prophylaxis with either anticoagulation or antiplatelet therapy.
8. Has ongoing corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 28 days prior to enrolment.
9. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.

Refer to Section 6.5 for information on COVID-19 vaccines.
10. Known intolerance to any of the study interventions and/or their excipients.
11. Received a strong inhibitor or inducer of CYP3A4 within 14 days prior to randomization or is expected to require chronic use of a strong CYP3A4 inhibitor or inducer during treatment with study intervention until 30 days after the last dose.
12. Received a strong modulator of CYP2D6 or P-gp within 14 days prior to randomization or is expected to require chronic use of a strong modulator of CYP2D6 or P-gp during treatment with study intervention until 30 days after the last dose
13. Is receiving an investigational agent or has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
14. Known additional malignancy that is progressing or has required active treatment within the past 2 years.
15. Known active CNS lymphoma. CNS staging at diagnosis with MRI brain/spine and CSF analysis is not mandatory and only required if there is a clinical suspicion of CNS involvement.
16. Active infection requiring systemic therapy.
17. Concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV RNA) infection.
18. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
19. History of solid organ transplant within 2 years of study enrollment.
20. Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2027
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,Washingto
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Olivia Newton-John Cancer Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Eliza A Hawkes, MBBS DMedSc
Address 0 0
Austin Health
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

No information has been provided regarding IPD availability


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/NCT07913594