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Peripheral T-Cell Lymphoma RefractoryPhase 2ZiVLenNCT07913594

Zilovertamab Vedotin and Lenalidomide (ZiVLen) Therapy for Relapsed/Refractory Peripheral T-Cell Lymphoma

A Phase 2 study testing Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg and Lenalidomide in people with Peripheral T-Cell Lymphoma Refractory, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study will test whether a combination of two medicines, zilovertamab vedotin (ZV) and lenalidomide, can help people with peripheral T-cell lymphoma that has come back after treatment or has not responded to previous treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T-Cell Lymphoma Refractory
What is being tested?
Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
5 sitesAustralia
Study dates
1 Jan 2027to 31 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 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.
  • 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.
  • Is an individual of any sex/gender, ≥18 years of age at the time of providing documented informed consent.
  • Patients of childbearing potential willing to adhere to the contraceptive precautions.
  • The participant (or legally acceptable representative) has provided documented informed consent for the study.
  • Additional Categories
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  • 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.
  • Has an ejection fraction ≥45% as determined by either ECHO or GCBP.
  • HIV infected participants must have well controlled HIV on ART.
  • 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

Who cannot join

  • Any other type of lymphoma except nodal PTCL as listed above.
  • 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.
  • Has QTcF prolongation of >480 msec.
  • Has ongoing Grade >1 peripheral neuropathy.
  • Has a demyelinating form of Charcot-Marie-Tooth disease.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
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  • 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.
  • 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.
  • 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.
  • Known intolerance to any of the study interventions and/or their excipients.
  • 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.
  • 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
  • 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.
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • 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.
  • Active infection requiring systemic therapy.
  • Concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV RNA) infection.
  • 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.
  • History of solid organ transplant within 2 years of study enrollment.
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

Australia5 sites

  • Monash Health

    Clayton, Victoria, 3168

    Chathuri Abeyakoon, MBBS, Chathuri.Abeyakoon@monashhealth.org

  • Austin Health

    Heidelberg, Victoria, 3084

    Eliza A Hawkes, MBBS DMedSc, +61 3 9496 5093, eliza.hawkes@austin.org.au

  • Sir Charles Gairdner Hospital

    Nedlands, Washington, 6009

    Dejan Radeski, MBBS, +61864577600, Dejan.Radeski@health.wa.gov.au

    Dejan Radeski, MBBS FRACP FRCPA

  • Concord Repatriation General Hospital

    Sydney, New South Wales, 2139

    Janlyn Falconer, MBBS, +612976775154, janlyn.falconer@health.nsw.gov.au

    Janlyn Falconer, MBBS

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Rakin Chowdhury, MBBS, Rakin.Chowdhury@health.qld.gov.au

Other trials in Australia

About this study

This study will test whether a combination of two medicines, zilovertamab vedotin (ZV) and lenalidomide, can help people with peripheral T-cell lymphoma that has come back after treatment or has not responded to previous treatment. The combination, called "ZiVLen", is designed to provide an alternative treatment approach that may use less chemotherapy than standard regimens. Researchers will evaluate how well this treatment works in controlling the lymphoma and will also assess its safety and side effects. The study will collect research biospecimens (archival tissue, and onstudy blood and stool samples) to investigate whether there are any immune system changes in participants who's lymphoma responds to the treatment compared to those who do not. In addition, health related quality of life surveys (patient reported outcome measures [PROMS]) will be collected to better understand whether the treatment and/or trial has impacted the health related quality of life of participants in their own voice. The results of this study will help determine whether ZiVLen should be studied further in larger clinical trials.

Being tested
Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg, Lenalidomide
Keywords
antibody drug conjugates, relapsed or refractory nodal PTCL, ROR-1, immunomodulatory
Medical subject headings
Recurrence

What participants receive

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

  • Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kgBiological

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

  • LenalidomideDrug

    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)

Study groups in NCT07913594
Study groupRoleWhat they receive
Zilovertamab vedotin (1.75mg/kg) Q3W + Lenalidomide (15mg p.o. 14 days)ExperimentalInduction 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.
Receives: Biological: Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg; Drug: Lenalidomide

What is being measured

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

  1. Rate of complete response to up to 6 cycles of combination zilovertamab vedotin and lenalidomide

    Rate of complete response to up to 6 cycles of combination zilovertamab vedotin and lenalidomide as determined by first documented disease progression per Lugano response criteria.

    Measured: Up to 18 weeks.

Secondary outcomes (5)

  1. Number of participants who experienced an adverse event (AE)

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the investigational products, is also an AE. The number of participants who experienced an AE will be reported.

    Measured: Up to 110 days after the last dose of investigational product.

  2. Overall survival (OS)

    As defined as the time from enrolment until death, due to any cause, will be reported.

    Measured: Up to 33 months

  3. Duration of response

    DOR, defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, will be reported.

    Measured: Up to 33 months

  4. Progression Free Survival

    PFS, defined as the time from enrolment to the first documented disease progression per Lugano response criteria as assessed by PET/CT or death due to any cause, whichever occurs first will be presented.

    Measured: Up to 33 months

  5. Change from baseline of health related quality of life

    EORTC-QLQ-C30 (baseline and end of treatment) and PRO-CTCAE (baseline and prior to each cycle of treatment and end of treatment) responses will be collected from participants to examine any changes in health related quality of life.

    Measured: Up to 9 months

Timeline

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

  1. First posted3 Nov 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07913594
Sponsor's protocol ID
ONJ2025-004
Acronym
ZiVLen
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg and Lenalidomide in people with Peripheral T-Cell Lymphoma Refractory, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.

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 13 inclusion and 21 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete response to up to 6 cycles of combination zilovertamab vedotin and lenalidomide (time frame: Up to 18 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 NCT07913594.

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 3 Nov 2026.

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