Epidermotropic T-cell LymphomasCUTALLONCT02520908
Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis
An observational study of Epidermotropic T-cell Lymphomas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epidermotropic T-cell Lymphomas
- What is being tested?
- HSCT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2016to 19 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced-stage epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome
Who may be able to join
- Age ≥ 18 and ≤ 65 years
- Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) / European Organisation for Research and Treatment of Cancer (EORTC) stage IIB, III, IVA or IVB ETCL
- Complete or partial response of the lymphoma (as defined by the international ISCL-EORTC criteria at the time of inclusion
- Written informed consent given by the patient
- Contraception in women of childbearing age
- Hematopoietic stem cell donor search underway
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- And at least one of the three following criteria:
- Refractoriness or early relapse (i.e. within one year) after at least one line of systemic chemotherapy (not including skin-directed therapies, methotrexate, interferon-alpha, and oral retinoids)
- Early histological large-cell transformation, i.e. within two years following ETCL diagnosis
- Histologically proven nodal (ISCL / EORTC N3) or extra-cutaneous visceral involvement by the lymphoma
Who cannot join
- Prior allogeneic HSCT
- Other progressive neoplastic disease
- Progressive psychotic disease
- Left ventricular ejection fraction < 50% (as determined by trans-thoracic echocardiography)
- Pulmonary disease with FEV1, FVC or DLCO <30% of expected corrected for hemoglobin.
- Creatinine clearance <50 ml/min or requiring dialysis
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- Transaminases or bilirubin >two-fold the normal value in the absence of liver involvement by the lymphoma
- Pregnant or breastfeeding woman
- Patient with no health coverage
- Patient under guardianship or curatorship
- HTLV-1 lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Controlled, Multicenter Cohort Study Evaluating the Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis
Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).
- Conditions
- Epidermotropic T-cell Lymphomas
- Being tested
- HSCT, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSCTProcedure or surgery
Hematopoietic stem cell transplantation
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| HSCT | Patients with an available sibling or 10/10 HLA-matched unrelated donor who undergo reduced-intensity conditioned allogeneic hematopoietic stem cell transplantation (HSCT), will be included in the study. The reduced-intensity conditioning usually includes Fludarabine 90 mg/m2 IV and Melphalan 140 mg/m2 IV. As usual care, patients will receive peripheral blood stem cells from their sibling donor if available, otherwise from their 10/10 HLA-matched unrelated donor Receives: Procedure: HSCT | |
| Standard care | Patients with no available sibling or 10/10 HLA-matched unrelated donor who therefore do not receive allogeneic HSCT but receive best standard of care treatment, will be included in the study, as the control group Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: 3 year
Secondary outcomes (6)
overall survival (OS)
Measured: 3 year
Neutrophils Engraftment
Neutrophils > 1,000 Giga/L
Measured: 180 days
Acute and chronic graft-versus-host disease (GVHD)
Measured: 180 days
Cumulative incidence of relapse
Measured: 3 years
Treatment-related mortality (TRM)
Measured: 12 months
Quality of life (QoL)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start23 Sep 2016
- Primary completion19 Nov 2024 (estimated)
- Study completion19 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidermotropic T-cell LymphomasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
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
- NCT02520908
- Sponsor's protocol ID
- NI 14018
- Acronym
- CUTALLO
- Status last verified
- Apr 2024
- First submitted
- 27 Jul 2015
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussiere-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marcais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socie G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Francais d'Etude des Lymphomes Cutanes; Societe Francaise de Greffe de Moelle et Therapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. doi: 10.1016/S0140-6736(23)00329-X. Epub 2023 Apr 24.
PubMed 37105210de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, Rouanet J, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Labussiere-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marcais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socie G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators, Groupe Francais d'Etude des Lymphomes Cutanes and Societe Francaise de Greffe de Moelle et Therapie Cellulaire. Overall Survival After Allogeneic Transplantation in Advanced Cutaneous T-Cell Lymphomas (CUTALLO): A Propensity Score-Matched Controlled Prospective Study. J Clin Oncol. 2025 Aug;43(22):2461-2466. doi: 10.1200/JCO-25-00183. Epub 2025 Jun 13.
PubMed 40513043
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Multicenter Cohort Study Evaluating the Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis
- ClinicalTrials.gov ID
- NCT02520908
- Acronym / sponsor ID
- CUTALLO / NI 14018
- Conditions
- Epidermotropic T-cell Lymphomas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 19 Nov 2024 (estimated)
- Study completion
- 19 Nov 2024 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- 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.
Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSCT | – | Procedure: HSCTPatients with an available sibling or 10/10 HLA-matched unrelated donor who undergo reduced-intensity conditioned allogeneic hematopoietic stem cell transplantation (HSCT), will be included in the study. The reduced-intensity conditioning usually includes Fludarabine 90 mg/m2 IV and Melphalan 140 mg/m2 IV. As usual care, patients will receive peripheral blood stem cells from their sibling donor if available, otherwise from their 10/10 HLA-matched unrelated donor |
| Standard care | – | Other: Standard CarePatients with no available sibling or 10/10 HLA-matched unrelated donor who therefore do not receive allogeneic HSCT but receive best standard of care treatment, will be included in the study, as the control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced-stage epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome
Key inclusion criteria (10 listed)
- Age ≥ 18 and ≤ 65 years
- Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) / European Organisation for Research and Treatment of Cancer (EORTC) stage IIB, III, IVA or IVB ETCL
- Complete or partial response of the lymphoma (as defined by the international ISCL-EORTC criteria at the time of inclusion
- Written informed consent given by the patient
- Contraception in women of childbearing age
Key exclusion criteria (11 listed)
- Prior allogeneic HSCT
- Other progressive neoplastic disease
- Progressive psychotic disease
- Left ventricular ejection fraction < 50% (as determined by trans-thoracic echocardiography)
- Pulmonary disease with FEV1, FVC or DLCO <30% of expected corrected for hemoglobin.
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 |
|---|---|---|
| HSCTHematopoietic stem cell transplantation | Procedure or surgery | HSCT |
| Standard Care | Other | Standard care |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 3 year
6 secondary outcomes
overall survival (OS)
Time frame: 3 year
Neutrophils Engraftment
Time frame: 180 days
Acute and chronic graft-versus-host disease (GVHD)
Time frame: 180 days
Cumulative incidence of relapse
Time frame: 3 years
Treatment-related mortality (TRM)
Time frame: 12 months
Quality of life (QoL)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 37105210de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussiere-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marcais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socie G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Francais d'Etude des Lymphomes Cutanes; Societe Francaise de Greffe de Moelle et Therapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. doi: 10.1016/S0140-6736(23)00329-X. Epub 2023 Apr 24.
- Derived from this study: PubMed 40513043de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, Rouanet J, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Labussiere-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marcais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socie G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators, Groupe Francais d'Etude des Lymphomes Cutanes and Societe Francaise de Greffe de Moelle et Therapie Cellulaire. Overall Survival After Allogeneic Transplantation in Advanced Cutaneous T-Cell Lymphomas (CUTALLO): A Propensity Score-Matched Controlled Prospective Study. J Clin Oncol. 2025 Aug;43(22):2461-2466. doi: 10.1200/JCO-25-00183. Epub 2025 Jun 13.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidermotropic T-cell Lymphomas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 3 year). 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 NCT02520908, which also lists 2 linked publications.
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 1 May 2024.