Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine
A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance
1 other identifier
interventional
71
2 countries
39
Brief Summary
This study is an open label, multicenter phase 2 study. The primary objective of the study is to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2018
Typical duration for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedStudy Start
First participant enrolled
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2022
CompletedJuly 30, 2025
July 1, 2025
1.8 years
April 5, 2018
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
rate of patient in Complete/Partial response according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).
16 weeks = 4 cycles or permanent treatment discontinuation
Secondary Outcomes (12)
Progression-Free Survival (PFS)
16 weeks = 4 cycles or permanent treatment discontinuation
Progression-Free Survival (PFS)
4.5 years
Complete Response Rate (CRR)
16 weeks = 4 cycles or permanent treatment discontinuation
Duration of Response (DoR)
16 weeks = 4 cycles or permanent treatment discontinuation
Duration of Response (DoR)
4.5 years
- +7 more secondary outcomes
Study Arms (1)
Experimental
EXPERIMENTALPatients treated with gemcitabine will receive Brentuximab Vedotin-induction for 4 cycles of induction. Patients who will obtain partial or complete response and who will be eligible for transplant will receive autologous or allogeneic stem cell transplantation. Patients who will obtain partial or complete response and who will not be eligible for transplant will receive maintenance therapy with Brentuximab Vedotin-maintenance every 3 weeks for 12 infusions.
Interventions
Brentuximab vedotin 1.8 mg/kg at D8 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy
Gemcitabine 1000 mg/m² at D1 and D15 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy
Patients who will obtain partial or complete response and who will not be eligible for transplant will receive maintenance therapy with brentuximab vedotin every 3 weeks for 12 infusions. Brentuximab vedotin 1.8 mg/kg at D1 of a 21-day cycle - 12 cycles = 36 weeks for maintenance therapy
Patients who will obtain partial or complete response and who will be eligible for transplant will receive autologous or allogeneic stem cell transplantation
Eligibility Criteria
You may qualify if:
- Males and females of 18 years to 80 years of age;
- Understand and voluntarily sign an informed consent document prior to any study related assessment or procedure;
- Patients able to adhere to the study visit schedule and protocol requirements;
- Patients with histologically proven, CD30 positive (at least 5% of cells according to local examination) peripheral T-cell lymphoma (PTCL) according to the 2016 World Health Organization (WHO) classification for whom gemcitabine treatment is expected. A biopsy at relapse is highly recommended;
- Patients who have evidence of relapsed disease after at least one line (and no more than three lines) of treatment or who were refractory to a first or subsequent line of treatment;
- Patients with Ann Arbor stage I - IV;
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
- Patients with at least one measurable disease, i.e. one nodal or extra-nodal lesion of 1.5 cm or more;
- Negative pregnancy test for females of childbearing potential (FCBP);
- Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 6 months thereafter.
- Males must use an effective method of birth control during treatment period and 6 months thereafter.
You may not qualify if:
- Any significant medical condition or laboratory abnormality unrelated to PTCL, or psychiatric illness that would prevent the patient from participating in the study and from signing the informed consent form;
- Any condition that confounds the ability to interpret data from the study;
- Other types of lymphomas, e.g. B-cell lymphoma;
- Central nervous system and/or meningeal involvement by PTCL;
- Signs or symptoms of Progressive Multifocal Leukoencephalopathy;
- Preexistent peripheral neuropathy ≥ grade 2, whatever the cause;
- Contraindication to any drug contained in the chemotherapy regimen;
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin;
- Subjects with HIV or HTLV1 positivity;
- Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without hepatitis B virus (HBV) DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible;
- Chronic or acute, clinically significant, untreated bacterial, viral or fungal infection;
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) \< 1500 cells/mm3 (1.5 x 109/L);
- Platelet count \<75,000/mm3 (75 x 109/L);
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3.0 x upper limit of normal (ULN). AST or ALT may be elevated up to 5 x ULN if their elevation can be ascribed to the presence of hematologic/solid tumor in the liver;
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
ZNA Stuivenberg
Antwerp, 2060, Belgium
A. Z. Sint-Jan
Bruges, 8000, Belgium
Clinique Universitaire Saint LUC
Brussels, 1200, Belgium
Institut Jules Bordet
Brussels, Belgium
ULB Hôpital Erasme
Brussels, Belgium
UZ Gent
Ghent, 9000, Belgium
CHU de Liege
Liège, 4000, Belgium
CHU UCL Namur
Yvoir, Belgium
IHBN - CHU Cote de Nacre
Amiens, 80054, France
CHU d'Amiens
Amiens, France
CHU Angers
Angers, 49033, France
CH d'Avignon - Hôpital Henri Dufaut
Avignon, 84000, France
CH Côte Basque
Bayonne, 64100, France
CHU de Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
CH Chambéry
Chambéry, 73011, France
CHU d'Estaing
Clermont-Ferrand, 63000, France
APHP - Hopital Henri Mondor
Créteil, 94010, France
CHU de Dijon - Hôpital le Bocage
Dijon, 21000, France
CHU Grenoble
Grenoble, 38043, France
CH de Versailles - Hopital André Mignot
Le Chesnay, 78157, France
CH du Mans
Le Mans, 72000, France
CHRU de Lille - Hôpital Claude Huriez
Lille, France
CHU de Limoges
Limoges, France
Centre Leon Berard
Lyon, 69373, France
Centre Hospitalier Annecy Genevois
Metz-Tessy, 74374, France
CH Saint-Eloi
Montpellier, 34295, France
CH de Mulhouse Sud Alsace
Mulhouse, 68070, France
CHU Nancy - Brabois
Nancy, 54511, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
APHP - Hôpital Necker
Paris, 75015, France
APHP - Hôpital Saint Louis
Paris, 75475, France
Centre François Magendie - Hôpital du Haut Lévêque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, 86021, France
CHU De Rennes
Rennes, 35033, France
Centre Henri BECQUEREL
Rouen, 76038, France
CHU de Toulouse
Toulouse, 31059, France
CHRU de Tours
Tours, 37044, France
CH de Valenciennes
Valenciennes, 59322, France
Related Publications (1)
Tournilhac O, Bouabdallah K, Lecolant S, Hacini M, Laribi K, Bailly S, Belmondo T, Maerevoet M, Ysebaert L, Guidez S, Le Gouill S, Bonnet C, Andre M, Dupuis J, Thieblemont C, Bachy E, Daguindau N, Morschhauser F, Tricot S, Moulin C, Banos A, Houot R, Chauchet A, Gyan E, Cartron G, Farhat H, Camus V, Drenou B, Zerazhi H, Sibon D, Nicolas-Virelizier E, Delette C, Snauwaert S, Bailly S, Delarue R, Carras S, Ledoux-Pilon A, Parrens MC, Griolet S, Gaulard P, Delfau-Larue MH, de Leval L, Damaj GL. Brentuximab vedotin addition to gemcitabine in relapsed or refractory peripheral T-cell lymphoma: a LYSA phase 2 study. Blood Adv. 2025 Dec 23;9(24):6292-6304. doi: 10.1182/bloodadvances.2024015787.
PMID: 40758949DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Richard DELARUE, MD
APHP - Hôpital Necker
- STUDY CHAIR
Olivier TOURNILHAC, MD
CHU Estaing - Clermont Ferrant
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 12, 2018
Study Start
April 10, 2018
Primary Completion
January 31, 2020
Study Completion
October 8, 2022
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share