Cutaneous T Cell Lymphoma (CTCL)Phase 3BeCALMNCT07178457
Brentuximab Vedotin in CutAneous T-cell Lymphomas (CTCL): Post-allogeneic Hematopoietic Stem Cell Transplant Maintenance
A Phase 3 study testing Brentuximab Vedotin (Bv) in people with Cutaneous T Cell Lymphoma (CTCL) and Brentuximab Vedotin, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Allogeneic hematopoietic stem cell transplantation (alloHSCT) showed efficacy in advanced-stage, high-risk, treatment sensitive cutaneous T-cell lymphomas (CTCL) in a prospective, propensity score-matched controlled study (CUTALLO) published by our group in the Lancet in 2023. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cutaneous T Cell Lymphoma (CTCL), Brentuximab Vedotin
- What is being tested?
- Brentuximab Vedotin (Bv)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Nov 2032
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jérôme Lambert, MD PhD contact
About this study
Allogeneic hematopoietic stem cell transplantation (alloHSCT) showed efficacy in advanced-stage, high-risk, treatment sensitive cutaneous T-cell lymphomas (CTCL) in a prospective, propensity score-matched controlled study (CUTALLO) published by our group in the Lancet in 2023. Nevertheless, it is associated with a high rate of early relapse, with 2-year progression-free survival around 30%. Brentuximab vedotin (BV) has shown efficacy in the treatment of CD30-expressing CTCL after at least one prior systemic treatment in the ALCANZA trial and is market approved in this indication in Europe and the United States of America. BV has been successfully used as salvage treatment in the post-transplant setting in advanced CTCL. It has been shown that 90% of CTCL express CD30. To reduce the incidence of post-allograft relapse, we propose to assess the routine use of BV post-allograft in adult patients with advanced CD30-expressing mycosis fungoides-CTCL, who have received at least one line of prior systemic therapy, compared to placebo. Switch will be allowed from placebo to BV in case of disease progression. This project is supported by well-organized research networks with a strong track-record of published results in the field: French Study Group on Cutaneous Lymphomas (GFELC, Groupe Français d'Etude des Lymphomes Cutanés), INCa-labelled national rare cancers network; and the French Society of Bone Marrow Transplantation and CellTherapy. In the post-transplant setting, the current state-of-the-art practice is to treat patients once they have relapsed post-allogeneic transplant, whereas no prophylactic treatment is given at the time in the absence of characterized disease relapse. This ethically and scientifically justifies the proposal to evaluate whether earlier, prophylactic treatment with BV increases progression-free survival compared to placebo.
- Being tested
- Brentuximab Vedotin (Bv), Placebo
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab Vedotin (Bv)Drug
1.8 mg/kg in 100 mlof NaCl 0.9%, Q3W with a maximum of 16 cycles
PlaceboDrug
NaCl 0.9% 100 ml IV Q3W with a maximum of 16 cycles
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab vedotin | Experimental | Not described Receives: Drug: Brentuximab Vedotin (Bv) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 2 years after randomization
Secondary outcomes (9)
Overall survival
Measured: 2 years after randomization
Quality of life scoring
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a 30-item scale with scores ranging from 0 to 100. A higher score indicates better quality of life.
Measured: At 1 year
Quality of life scoring
The Skindex-29 is a 29-item questionnaire assessing the impact of skin diseases on quality of life, with scores ranging from 0 to 100. Higher scores indicate greater impairment in quality of life.
Measured: At 1 year
Cumulative incidence of disease relapse
Measured: At 2 years
Cumulative incidence of acute graft-versus-host disease (GVHD)
Measured: At 2 years
Cumulative incidence of chronic GVHD
Measured: At 2 years
Cumulative incidence of non-relapse mortality
Measured: At 2 years
Quality of life scoring
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a 30-item scale with scores ranging from 0 to 100. A higher score indicates better quality of life.
Measured: At 2 years
Quality of life scoring
The Skindex-29 is a 29-item questionnaire assessing the impact of skin diseases on quality of life, with scores ranging from 0 to 100. Higher scores indicate greater impairment in quality of life.
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell Lymphoma (CTCL)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, prospective, double-blind, placebo-controlled, (ratio 1:1) randomized study, with randomization stratified on donor type, previous use of BV or not and Complete Response (CR)/Partial Response (PR)/Stable disease (SD) after 1st course of BV
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178457
- Sponsor's protocol ID
- APHP241010
- Acronym
- BeCALM
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brentuximab Vedotin in CutAneous T-cell Lymphomas (CTCL): Post-allogeneic Hematopoietic Stem Cell Transplant Maintenance
- ClinicalTrials.gov ID
- NCT07178457
- Acronym / sponsor ID
- BeCALM / APHP241010
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allogeneic hematopoietic stem cell transplantation (alloHSCT) showed efficacy in advanced-stage, high-risk, treatment sensitive cutaneous T-cell lymphomas (CTCL) in a prospective, propensity score-matched controlled study (CUTALLO) published by our group in the Lancet in 2023. Nevertheless, it is associated with a high rate of early relapse, with 2-year progression-free survival around 30%. Brentuximab vedotin (BV) has shown efficacy in the treatment of CD30-expressing CTCL after at least one prior systemic treatment in the ALCANZA trial and is market approved in this indication in Europe and the United States of America. BV has been successfully used as salvage treatment in the post-transplant setting in advanced CTCL. It has been shown that 90% of CTCL express CD30. To reduce the incidence of post-allograft relapse, we propose to assess the routine use of BV post-allograft in adult patients with advanced CD30-expressing mycosis fungoides-CTCL, who have received at least one line of prior systemic therapy, compared to placebo. Switch will be allowed from placebo to BV in case of disease progression. This project is supported by well-organized research networks with a strong track-record of published results in the field: French Study Group on Cutaneous Lymphomas (GFELC, Groupe Français d'Etude des Lymphomes Cutanés), INCa-labelled national rare cancers network; and the French Society of Bone Marrow Transplantation and CellTherapy. In the post-transplant setting, the current state-of-the-art practice is to treat patients once they have relapsed post-allogeneic transplant, whereas no prophylactic treatment is given at the time in the absence of characterized disease relapse. This ethically and scientifically justifies the proposal to evaluate whether earlier, prophylactic treatment with BV increases progression-free survival compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multicentre, prospective, double-blind, placebo-controlled, (ratio 1:1) randomized study, with randomization stratified on donor type, previous use of BV or not and Complete Response (CR)/Partial Response (PR)/Stable disease (SD) after 1st course of BV
| Arm | Type | Receives |
|---|---|---|
| Brentuximab vedotin | Experimental | Drug: Brentuximab Vedotin (Bv) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab Vedotin (Bv)1.8 mg/kg in 100 mlof NaCl 0.9%, Q3W with a maximum of 16 cycles | Drug | Brentuximab vedotin |
| PlaceboNaCl 0.9% 100 ml IV Q3W with a maximum of 16 cycles | Drug | Placebo |
Primary outcome
Progression Free Survival
Time frame: 2 years after randomization
9 secondary outcomes
Overall survival
Time frame: 2 years after randomization
Quality of life scoring
Time frame: At 1 year
Quality of life scoring
Time frame: At 1 year
Cumulative incidence of disease relapse
Time frame: At 2 years
Cumulative incidence of acute graft-versus-host disease (GVHD)
Time frame: At 2 years
Cumulative incidence of chronic GVHD
Time frame: At 2 years
Cumulative incidence of non-relapse mortality
Time frame: At 2 years
Quality of life scoring
Time frame: At 2 years
Quality of life scoring
Time frame: At 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jérôme Lambert, MD PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brentuximab Vedotin (Bv) in people with Cutaneous T Cell Lymphoma (CTCL) and Brentuximab Vedotin, run by Assistance Publique - Hôpitaux de Paris.
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 17 inclusion and 14 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Adèle de Masson, MD PhD (+33 (0)1 71 20 75 01 ext. +33, adele.demasson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 2 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.