Peripheral T Cell LymphomaTRANSCRIPTNCT05444712
Transplantation After Complete Response In Patients With T-cell Lymphoma
A study testing Chemotherapy + follow up and Chemotherapy + ASCT + follow up in people with Peripheral T Cell Lymphoma, run by Hospices Civils de Lyon at 48 sites in France.
Trial summary
Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Chemotherapy + follow up and Chemotherapy + ASCT + follow up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 48 sitesFrance
- Study dates
- 1 Aug 2022to 1 Apr 2028
- Phase
- Interventional
- 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
- Patient ≥ 18 years and < 70 years of age at the time of signing the informed consent form (ICF)
- Patient fit enough to receive autologous stem cell transplant as a consolidation strategy as assessed by the local investigator
- Hemoglobin level > 8g/dL (transfusion allowed); Neutrophil count >0.5 G/L; Platelets count > 50 G/L (transfusion allowed) Patient with histologically proven "nodal-type peripheral T-cell lymphoma (PTCL)" (latest WHO classification), not previously treated; as defined by the WHO classification, the following subtypes may be included,
- PTCL, not otherwise specified
- Follicular helper T-cell lymphomas: Angioimmunoblastic T-cell lymphoma and nodal PTCL with TFH phenotype and follicular T-cell lymphoma
- Anaplastic large cell lymphoma, ALK-negative
Show all 17Show fewer
- Ann Arbor staging (I-IV) except stage I with normal LDH and PS<2 (i.e. stage I aaIPI 0)
- Participant with a measurable disease by the Lugano criteria (i.e., longest diameter of a nodal site > 1.5 cm and/or longest diameter of an extranodal site > 1.0 cm and/or a hypermetabolic lesion)
- FFPE Diagnostic tissue block should be available for central pathology review and ancillary molecular analyses
- Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Estimated minimum life expectancy of 3 months
- Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
- Able to adhere to the study visit schedule and other protocol requirements
- Patient covered by any social security system (France)
- Patient who understands and speaks one of the country official languages
- Males with partners of childbearing potential must agree to use effective birth control methods during the study as informed by the investigator in accordance with SmPC of each drugs administrated
- Females of childbearing potential must agree to use effective birth control methods for at least 28 days before starting treatment; while participating in the study; during treatment interruptions and necessary period after the study as informed by the investigator in accordance with SmPC of each drugs administrated
Who cannot join
- Known central nervous system or meningeal involvement by lymphoma
- Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (serum total bilirubin level > 2.0 mg/dl [34 µmol/L] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), serum transaminases (AST or ALT) > 3 upper normal limit unless they are related to the lymphoma.
- The following types of T-cell lymphomas:
- Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
- Extranodal T-cell/NK-cell lymphoma, nasal type
- Anaplastic large cell lymphoma, ALK-positive type
Show all 30Show fewer
- Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome)
- Primary cutaneous CD30+ T-cell lymphoproliferative disorder
- Primary cutaneous anaplastic T-cell lymphoma
- Enteropathy-associated T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Primary cutaneous gamma-delta T-cell lymphoma
- Primary cutaneous CD8+ aggressive epidermotropic lymphoma
- Primary cutaneous CD4+ small/medium T-cell lymphoma
- Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease for ≥ 2 years. However, patients with the following history are allowed:
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis clinical staging system
- Vaccinated with live, attenuated vaccines within 6 months of enrollment
- Use of any standard or experimental anti-cancer drug therapy before the start of treatment except COP (cyclophosphamide, vincristine, prednisone) in case of (or high risk of tumor lysis syndrome) or etoposide for a maximum of 3 doses (at a maximum dose of 150mg/m2) for HLH (Hemophagocytic Lymphohistiocytosis).
- A corticosteroids therapy > 1mg/kg lasting more than 14 days prior to Cycle 1 Day 1
- Positive serology for Human Immunodeficiency Virus (HIV) and Human T-Lymphotrophic Virus (HTLV1)
- 15. Active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections defined as:
- HBV :
- HBs Ag positive
- HBs Ag negative, anti-HBs antibody positive and anti-HBc antibody positive with detectable viral DNA
- HCV :
- Anti-VHC antibody positive with detectable viral RNA 9. Pregnant, planning to become pregnant or lactating WOCBP 10. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with the participation in this clinical study (according to the investigator's decision) 11. Person deprived of his/her liberty by a judicial or administrative decision 12. Person hospitalized without consent 13. Adult person under legal protection
Trial locations and contacts
48 sites in 1 country. Contact the study team or a site near you to ask about taking part.
48 sites in 1 country
France48 sites, 48 recruiting
- Not yet recruiting
Chu D'Amiens - Hopital Sud
Amiens, 80054
Caroline DELETTE, MD, Delette.caroline@chu-amiens.fr
Caroline DELETTE
- Not yet recruiting
Chu D'Angers
Angers, 49933
Aline CLAVERT, MD, Aline.clavert@chu-angers.fr
Aline CLAVERT
- Not yet recruiting
Ch Victor Dupouy
Argenteuil
Ahmad AL JIJAKLI, MD, Ahmad.aljijakli@ch-argenteuil.fr
Ahmad AL JIJAKLI
- Not yet recruiting
Ch D'Avignon - Hopital Henri Duffaut
Avignon, 84000
Hacène ZERAZHI, hzerazhi@ch-avignon.fr
Hacène ZERAZHI, MD
- Not yet recruiting
Ch de La Cote Basque
Bayonne, 64109
Sophie BERNARD, MD, Sophie.s.bernard@gmail.com
Sophie BERNARD
- Not yet recruiting
Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Olivier FITOUSSI, MD, +33 (0) 5 56 43 73 54, o.fitoussi@bordeauxnord.com
Olivier FITOUSSI
- Not yet recruiting
Ch Metropole Savoie - Site Chambery
Chambéry, 73000
Arthur DONY, Arthur.dony@ch-metropole-savoie.fr
Arthur DONY
- Not yet recruiting
Chu Estaing
Clermont-Ferrand
Olivier TOURNILHAC, MD, otournilhac@chu-clermontferrand.fr
Olivier TOURNILHAC
- Not yet recruiting
Ch Alpes Leman
Contamine-sur-Arve
Blandine BOUTIN, bboutin@ch-alpes-leman.fr
Blandine BOUTIN
- Not yet recruiting
Hopital Henri Mondor
Créteil, 94010
François LEMONNIER, MD
François LEMONNIER
- Not yet recruiting
René Olivier Casasnovas
Dijon, 21000
Franck Morschhauser, MD, 33 3 20 44 42 90, f-morschhauser@chu-lille.fr
Franck Morschhauser
- Not yet recruiting
CHU Francois MITTERRAND
Dijon
René-Olivier CASASNOVAS, MD, 03 80 29 50 41, olivier.casasnovas@chu-dijon.fr
René-Olivier CASASNOVAS, MD
- Not yet recruiting
Ch de Dunkerque
Dunkirk
Sarah BARBIEUX, MD, Sarah.barbieux@ch-dunkerque.Fr
Sarah BARBIEUX
- Not yet recruiting
Chd de Vendee
La Roche-sur-Yon
Stéphane VIGOUROUX, MD, Stephane.vigourous@ght85.frf
Stéphane VIGOUROUX
- Not yet recruiting
Ch de Versailles - Hopital Andre Mignot
Le Chesnay
Milena KOHN, MD, mikohn@ch-versailles.fr
Milena KOHN
- Not yet recruiting
CHU du Mans
Le Mans
Kamel LARIBI, MD, klaribi@ch-lemans.fr
Kamel LARIBI
- Not yet recruiting
Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
Lille, 59020
Sandy AMORIM, MD, +33 (0)3 20 87 45 32, amorim.sandy@ghicl.net
Sandy AMORIM
- Not yet recruiting
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
Limoges, 87042
Julie ABRAHAM, MD, +33 (0)5 55 05 66 51, julie.abraham@chu-limoges.fr
Julie ABRAHAM
- Not yet recruiting
Centre Leon Berard
Lyon, 69373
Yann GUILLERMIN, Yann.guillermin@lyon.unicancer.fr
Yann GUILLERMIN
- Not yet recruiting
Chu de Montpellier
Montpellier
Charles HERBAUX, Md, c-herbaux@chu-montpellier.fr
Charles HERBAUX
- Not yet recruiting
Chu de Nantes
Nantes
Benoit TESSOULIN, Md, Benoit.tessoulin@chu-nantes.fr
Benoit TESSOULIN
- Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
Frédéric PEYRADE, MD, Frederic.peyrade@nice.unicancer.fr
Frédéric PEYRADE
- Not yet recruiting
Chu de Nimes - Hopital Caremeau
Nîmes
Agathe WAULTIER - RASCALOU, MD, Agathe.waultier.rascalou@chu-nimes.fr
Agathe WAULTIER - RASCALOU
- Not yet recruiting
Chr Orleans
Orléans
Marlène OCHMANN, MD, Marlene.ochmann@chr-orleans.fr
Marlène OCHMANN
- Not yet recruiting
Hopital Cochin
Paris, 75014
Bénédicte DEAU-FISCHER, Benedicte.deau@aphp.fr
Bénédicte DEAU-FISCHER
- Not yet recruiting
Hopital de La Pitie Salpetriere
Paris, 75651
Sylvain CHOQUET, MD, sylvain.choquet@aphp.fr
Sylvain CHOQUET
- Not yet recruiting
Hopital Necker
Paris, 75743
Ambroise MARCAIS, MD, Ambroise.marcais@aphp.fr
Ambroise MARCAIS
- Not yet recruiting
Hopital Saint Antoine
Paris
Mohamad MOHTY, MD, Mohamad.mohty@inserm.fr
Mohamad MOHTY
- Not yet recruiting
Ch Perigueux
Périgueux
Claire CALMETTES, MD, Claire.calmettes@ch-perigueux.fr
Claire CALMETTES
- Not yet recruiting
Ch de Perpignan
Perpignan
Sara BURCHERI, MD, Sara.burcheri@ch-perpignan.Fr
Sara BURCHERI
- Not yet recruiting
Chu de Bordeaux - Hopital Haut-Leveque
Pessac
François-Xavier GROS, MD, Francois-xavier.gros@chu-bordeaux.fr
François-Xavier GROS
- Recruiting
Chu Lyon-Sud
Pierre-Bénite, 69495
Emmanuel BACHY, MD, Emmanuel.bachy@chu-lyon.fr
Emmanuel BACHY
- Not yet recruiting
Ch Annecy Genevois
Pringy
Nicolas DAGUINDAU, MD, ndaguindau@ch-annecygenevois.fr
Nicolas DAGUINDAU
- Not yet recruiting
Chu Pontchaillou_Rennes
Rennes, 35033
Roch HOUOT, MD, Roch.houot@chu-rennes.fr
Roch HOUOT
- Not yet recruiting
Ch de Roubaix - Hopital Victor Provo
Roubaix
Julia HIEULLE, MD, Julia.hieulle@ch-roubaix.fr
Julia HIEULLE
- Not yet recruiting
Centre Henri Becquerel
Rouen, 76038
Vincent CAMUS, MD, Vincent.camus@chb.unicancer.fr
Vincent CAMUS
- Not yet recruiting
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, 92210
Carole SOUSSAIN, MD, +33 (0)1 47 11 15 15, carole.soussain@curie.fr
- Not yet recruiting
Chu de La Reunion - Hopital Felix Guyon
Saint-Denis
Marie DE CHARRETTE, MD, marie.de-charette@chu-reunion.fr
Marie DE CHARRETTE
- Not yet recruiting
Chu de La Reunion - Ghsr
Saint-Pierre
Hugo LEGENDRE, MD, Hugo.legendre@chu-reunion.Fr
Hugo LEGENDRE
- Not yet recruiting
Institut Cancerologie & Hematologie St-Etienne
Saint-Priest-en-Jarez, 42270
Jérôme CORNILLON, MD, Jerome.cornillon@icloire.fr
Jérôme CORNILLON
- Not yet recruiting
Ch de Saint-Quentin
Saint-Quentin
Réda GARIDI, Md, r.garidi@ch-stquentin.fr
Réda GARIDI
- Not yet recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Luc-Matthieu FORNECKER, MD, 03 88 12 76 79 ext. +33, luc-matthieu.fornecker@chru-strasbourg.fr
Luc-Matthieu FORNECKER, MD
- Not yet recruiting
Institut Universitaire du Cancer
Toulouse
Loïc YSEBAERT, MD, 05 31 15 63 51 ext. +33, ysebaert.loic@iuct-oncopole.fr
Loïc YSEBAERT, MD
- Not yet recruiting
Chu Bretonneau
Tours
Laurianne DRIEU LA ROCHELLE, MD, l.drieu-la-rochelle@chu-tours.fr
Laurianne DRIEU LA ROCHELLE
- Not yet recruiting
Ch de Valence
Valence
Clémence SANTANA, MD, Clemence.santana@ch-valence.fr
Clémence SANTANA
- Not yet recruiting
Ch de Valenciennes - Hopital Jean Bernard
Valenciennes
Sabine TRICOT, MD, tricot-s@ch-valenciennes.Fr
Sabine TRICOT
- Not yet recruiting
Chu Brabois
Vandœuvre-lès-Nancy, 54511
Charline MOULIN, MD, c.moulin@chru-nancy.fr
Charline MOULIN
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94805
Vincent RIBRAG, MD, Vincent.ribrag@gustaveroussy.fr
Vincent RIBRAG
About this study
Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL.
The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Chemotherapy + follow up, Chemotherapy + ASCT + follow up
- Keywords
- peripheral T-cell Lymphoma, autologous stem cell transplantation, chemotherapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy + follow upProcedure or surgery
- Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices.
- An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL)
- A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients
- A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients
Chemotherapy + ASCT + follow upProcedure or surgery
- Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices.
- An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL)
- The fifth or sixth cycles should be used as stem-cell mobilizing chemotherapy for patients with ASCT strategy
- A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients
- Patients with in Complete Response after 6 cycles will receive a High Dose Therapy as conditioning regimen before transplantation
- A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | The chemotherapy is one of the following regimen administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices and European Medical Agency (EMA) approval :
* "Cyclophosphamide, doxorubicin, Vincristine and prednisone": (CHOP)
* "Cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone": (CHOEP)
* "Brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone": (BV-CHP) for ALCL lymphoma only (based on EMA approval) Receives: Procedure: Chemotherapy + follow up |
| Chemotherapy + ASCT | Active comparator | Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices:
Patients with ASCT strategy in Complete Response after 6 cycles will receive a High Dose Therapy (HDT) composed of BCNU, etoposide, cytarabine and melphalan (BEAM) as conditioning regimen before transplantation. That consolidation phase will lasts between 2 to 3 months Receives: Procedure: Chemotherapy + ASCT + follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess if ASCT is associated with a significant prolongation of progression-free survival (PFS) for patient with peripheral T-cell lymphoma (PTCL) reaching a complete response (CR) according to the response critter
progression-free survival defined time from the date of randomization to the date of first documentation of relapse or progressive disease, death due to any cause, or receipt of subsequent systemic chemotherapy to treat residual or progressive peripheral T-cell lymphoma as determined by the investigator, whichever came first.
Measured: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Secondary outcomes (12)
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall survival (OS)
Overall survival will be measured from the date of randomization to the date of death from any cause
Measured: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall response rate (ORR) and Complete Response Rate (CRR)
Overall Response Rate is defined as the proportion of subjects achieving best overall response of partial metabolic response (PMR) or complete metabolic response (CMR) at the end of ASCT (8-12 weeks after PIE). Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Measured: At the end of ASCT (8-12 weeks after post-induction evaluation)
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of duration of Response (DoR)
Duration of response will be measured from the time of attainment of CMR or PMR to the date of first documented disease progression, relapse (based on investigator disease assessment), death from any cause or receipt of subsequent systemic chemotherapy to treat residual or progressive peripheral T-cell lymphoma as determined by the investigator, whichever came first.
Measured: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of time to next Treatment (TTNT)
TTNT will be measured from the date of randomization to the date of first documented administration of new anti-lymphoma treatment.
Measured: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of quality of Life
The EuroQol 5 Dimensions questionnaire (EQ5D-5L) will be administered at baseline and every three months during follow-up visit.
Measured: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of cost-Effectiveness Analysis
Will be expressed as the extra cost per a quality adjusted life year. To assess the mean cost per patient of each group, the number of resources consumed and the amounts refunded will be extracted from the French National Health Insurance Information System. The number of QALYs in each group of the trial will be assessed with survival time and the validated EuroQol 5 Dimensions questionnaire (EQ5D-5L).
Measured: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of budget Impact Analysis
budget impact analysis to assess the potential annual economic impact of the new management recommendation (with or without ASCL) for the French Public Health Insurance System across a 3-year time period.
Measured: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Overall Response Rate (ORR)
Overall Response Rate is defined as the proportion of subjects achieving best overall response of partial metabolic response (PMR) at the end of induction. Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Measured: at the end of induction (between 3 and 5 weeks after the last drug administration)
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Complete Response rate (CRR)
complete metabolic response is defined as the proportion of subjects achieving complete metabolic response (CMR) at the end of induction. Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Measured: at the end of induction (between 3 and 5 weeks after the last drug administration)
To evaluate the predictive value of total metabolic tumor volume (TMTV) on PET-CT
Predictive value of TMTV on PET-CT
Measured: at patient enrollment
To Evaluate PET-CT Omics
PET-Omics
Measured: at patient enrollment
The assessment of the early PET-CT predictive value after four cycles of chemotherapy on treatment response according to the IWC (International Workshop Criteria) Lugano 2014
Predictive value of an early PET_CT after 4 cycles of chemotherapy on treatment response according to the IWC Lugano 2014
Measured: After four cycles of chemotherapy (each cycle is 3weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Aug 2022
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel BACHY, Pr, Principal investigator, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444712
- Sponsor's protocol ID
- 69HCL21_1095
- Acronym
- TRANSCRIPT
- Status last verified
- Sep 2023
- First submitted
- 8 Jun 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation After Complete Response In Patients With T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05444712
- Acronym / sponsor ID
- TRANSCRIPT / 69HCL21_1095
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- peripheral T-cell Lymphoma, autologous stem cell transplantation, chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 6 Jul 2022 (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.
Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL.
The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Procedure: Chemotherapy + follow upThe chemotherapy is one of the following regimen administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices and European Medical Agency (EMA) approval : * "Cyclophosphamide, doxorubicin, Vincristine and prednisone": (CHOP) * "Cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone": (CHOEP) * "Brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone": (BV-CHP) for ALCL lymphoma only (based on EMA approval) |
| Chemotherapy + ASCT | Active comparator | Procedure: Chemotherapy + ASCT + follow upChemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices: Patients with ASCT strategy in Complete Response after 6 cycles will receive a High Dose Therapy (HDT) composed of BCNU, etoposide, cytarabine and melphalan (BEAM) as conditioning regimen before transplantation. That consolidation phase will lasts between 2 to 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient ≥ 18 years and < 70 years of age at the time of signing the informed consent form (ICF)
- Patient fit enough to receive autologous stem cell transplant as a consolidation strategy as assessed by the local investigator
- Hemoglobin level > 8g/dL (transfusion allowed); Neutrophil count >0.5 G/L; Platelets count > 50 G/L (transfusion allowed) Patient with histologically proven "nodal-type peripheral T-cell lymphoma (PTCL)" (latest WHO classification), not previously treated; as defined by the WHO classification, the following subtypes may be included,
- Ann Arbor staging (I-IV) except stage I with normal LDH and PS<2 (i.e. stage I aaIPI 0)
- Participant with a measurable disease by the Lugano criteria (i.e., longest diameter of a nodal site > 1.5 cm and/or longest diameter of an extranodal site > 1.0 cm and/or a hypermetabolic lesion)
Key exclusion criteria (30 listed)
- Known central nervous system or meningeal involvement by lymphoma
- Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (serum total bilirubin level > 2.0 mg/dl [34 µmol/L] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), serum transaminases (AST or ALT) > 3 upper normal limit unless they are related to the lymphoma.
- The following types of T-cell lymphomas:
- Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease for ≥ 2 years. However, patients with the following history are allowed:
- Vaccinated with live, attenuated vaccines within 6 months of enrollment
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 |
|---|---|---|
| Chemotherapy + follow up* Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients | Procedure or surgery | Chemotherapy |
| Chemotherapy + ASCT + follow up* Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * The fifth or sixth cycles should be used as stem-cell mobilizing chemotherapy for patients with ASCT strategy * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * Patients with in Complete Response after 6 cycles will receive a High Dose Therapy as conditioning regimen before transplantation * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients | Procedure or surgery | Chemotherapy + ASCT |
Primary outcome
to assess if ASCT is associated with a significant prolongation of progression-free survival (PFS) for patient with peripheral T-cell lymphoma (PTCL) reaching a complete response (CR) according to the response critter
Time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
progression-free survival defined time from the date of randomization to the date of first documentation of relapse or progressive disease, death due to any cause, or receipt of subsequent systemic chemotherapy to treat residual or progressive peripheral T-cell lymphoma as determined by the investigator, whichever came first.
12 secondary outcomes
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall survival (OS)
Time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall response rate (ORR) and Complete Response Rate (CRR)
Time frame: At the end of ASCT (8-12 weeks after post-induction evaluation)
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of duration of Response (DoR)
Time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of time to next Treatment (TTNT)
Time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of quality of Life
Time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of cost-Effectiveness Analysis
Time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of budget Impact Analysis
Time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Overall Response Rate (ORR)
Time frame: at the end of induction (between 3 and 5 weeks after the last drug administration)
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Complete Response rate (CRR)
Time frame: at the end of induction (between 3 and 5 weeks after the last drug administration)
To evaluate the predictive value of total metabolic tumor volume (TMTV) on PET-CT
Time frame: at patient enrollment
To Evaluate PET-CT Omics
Time frame: at patient enrollment
The assessment of the early PET-CT predictive value after four cycles of chemotherapy on treatment response according to the IWC (International Workshop Criteria) Lugano 2014
Time frame: After four cycles of chemotherapy (each cycle is 3weeks)
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 28 Sep 2023.
Related trials for Peripheral T Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Not yet recruitingPhase 2
Allogeneic Cell Therapy in Refractory T-Cell Lymphoma
Lymphoma, T Cell, Peripheral
RecruitingPhase 2
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma
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.
Emmanuel BACHY, Pr principal investigator
HCL
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy + follow up and Chemotherapy + ASCT + follow up in people with Peripheral T Cell Lymphoma, run by Hospices Civils de Lyon at 48 sites 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 17 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites 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?
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 Emmanuel BACHY, Pr (+33(0) 4 78 86 22 05, emmanuel.bachy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess if ASCT is associated with a significant prolongation of progression-free survival (PFS) for patient with peripheral T-cell lymphoma (PTCL) reaching a complete response (CR) according to the response critter (time frame: When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first). 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 28 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.