New drug aims to stop skin lymphoma from returning after transplant

NCT ID NCT07178457

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tests whether the drug brentuximab vedotin can prevent relapse in people with advanced cutaneous T-cell lymphoma (CTCL) who have recently had a stem cell transplant. About 84 adults with CD30-positive CTCL will receive either the drug or a placebo every three weeks for up to 16 cycles. The goal is to see if early treatment improves progression-free survival compared to waiting until the cancer returns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brentuximab vedotin
What this could lead to
If successful, this could offer a way to keep advanced CTCL from coming back after a stem cell transplant, potentially extending remission.
What could go wrong
This is a phase 3 trial, but it is not yet recruiting. The drug may cause side effects, and it is unclear if it will improve survival compared to waiting until relapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be eligible for study entry, patients must meet all of the following criteria: * Age ≥ 18 and ≤ 70 years * Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry * ECOG performance status 0-1 * Relapsed or refractory to at least one line of systemic treatment * Complete or partial response of the lymphoma at the time of study inclusion * Having received recent alloHSCT from a sibling, 10/10 or 9/10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion) * Adequate liver function: * Total bilirubin ≤ 2 xULN, or Direct bilirubin ≤ 2xULN if total bilirubin is \>2xULN, or total bilirubin \>2 xULN if elevated total bilirubin is attributed to Gilbert's syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN * Adequate hematological function: * Absolute neutrophil count of ≥ 1.0 G/L * Platelet count of ≥ 50 G/L * Hemoglobin ≥ 9 g/dL * Adequate renal function: creatinine clearance calculated by Cockcroft \& Gault formula of ≥ 50 mL/min * Patient affiliated to life insurance * Written informed consent given by the patient Exclusion Criteria: Any of the following criteria requires the exclusion of the patient before randomization: * Second or higher allogeneic HSCT, * Other progressive neoplastic or psychotic disease, * Left ventricular ejection fraction \< 50%, carbone monoxide diffusion capacity \< 50% of the theoretical value, * History of BV-induced adverse event without resolution to current grade \<2. Previous treatment with brentuximab vedotin alone, in the absence of current ≥ grade 2 BV-induced side effect, is NOT an exclusion criterion. * History of disease refractoriness, progression or relapse during BV treatment. Previous treatment with BV alone, if the disease was treatment-sensitive (complete, partial response or stable disease), is NOT an exclusion criterion. * History of ≥ grade 4 adverse event induced by BV. Previous \<grade 4 adverse event induced by BV is not an exclusion criterion if the adverse event has regressed to grade\<2. * Contra-indication to BV including current \>grade 2 neutropenia or active infection, * Progressive disease or relapse at study inclusion compared to the screening visit status, * Refusal of highly effective birth control method for female participant of childbearing potential and male participant with a female partner of childbearing potential, * Pregnant and/or breastfeeding women, * Participation to another interventional clinical trial, * Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice), * Patients deprived of their liberty by a judicial or administrative decision

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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