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Refractory Peripheral T-Cell LymphomaPhase 2NCT03496779

Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine

A Phase 2 study testing Brentuximab Vedotin - induction, Gemcitabine and Brentuximab Vedotin - maintenance in people with Refractory Peripheral T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Brentuximab Vedotin - induction, Gemcitabine and Brentuximab Vedotin - maintenance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
39 sitesin 2 countries
Study dates
10 Apr 2018to 8 Oct 2022
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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.

Who cannot join

  • 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;
Show all 30Show fewer
  • 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;
  • Serum total bilirubin > 1.5 x ULN;
  • Serum lipase level > 2 x ULN;
  • Serum creatinine > 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance < 40 mL/minute;
  • Hemoglobin < 8g/dL;
  • Active malignancies other than PTCL requiring systemic treatment;
  • Previous treatment with brentuximab vedotin;
  • Previous treatment with gemcitabine;
  • Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study;
  • Known history of any of the following cardiovascular conditions:
  • Myocardial infarction within 2 years of enrollment
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
  • Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment;
  • Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

France31 sites

  • IHBN - CHU Cote de Nacre

    Amiens, 80054

  • CHU d'Amiens

    Amiens

  • CHU Angers

    Angers, 49033

  • CH d'Avignon - Hôpital Henri Dufaut

    Avignon, 84000

  • CH Côte Basque

    Bayonne, 64100

  • CHU de Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • CH Chambéry

    Chambéry, 73011

  • CHU d'Estaing

    Clermont-Ferrand, 63000

  • APHP - Hopital Henri Mondor

    Créteil, 94010

  • CHU de Dijon - Hôpital le Bocage

    Dijon, 21000

  • CHU Grenoble

    Grenoble, 38043

  • CH de Versailles - Hopital André Mignot

    Le Chesnay, 78157

  • CH du Mans

    Le Mans, 72000

  • CHRU de Lille - Hôpital Claude Huriez

    Lille

  • CHU de Limoges

    Limoges

  • Centre Leon Berard

    Lyon, 69373

  • Centre Hospitalier Annecy Genevois

    Metz-Tessy, 74374

  • CH Saint-Eloi

    Montpellier, 34295

  • CH de Mulhouse Sud Alsace

    Mulhouse, 68070

  • CHU Nancy - Brabois

    Nancy, 54511

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

  • APHP - Hôpital Necker

    Paris, 75015

  • APHP - Hôpital Saint Louis

    Paris, 75475

  • Centre François Magendie - Hôpital du Haut Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers, 86021

  • CHU De Rennes

    Rennes, 35033

  • Centre Henri BECQUEREL

    Rouen, 76038

  • CHU de Toulouse

    Toulouse, 31059

  • CHRU de Tours

    Tours, 37044

  • CH de Valenciennes

    Valenciennes, 59322

Other trials in France

Belgium8 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • A. Z. Sint-Jan

    Bruges, 8000

  • Clinique Universitaire Saint LUC

    Brussels, 1200

  • Institut Jules Bordet

    Brussels

  • ULB Hôpital Erasme

    Brussels

  • UZ Gent

    Ghent, 9000

  • CHU de Liege

    Liège, 4000

  • CHU UCL Namur

    Yvoir

Other trials in Belgium

About this study

Official title: 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

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).

Read the detailed description

Currently, there is no standard treatment for patients with recurrent or refractory peripheral T-cell lymphoma who relapse after a first line of cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone (CHOP) treatment.

Chemotherapies such as gemcitabine are used as monotherapy but the results alone are insufficient. In addition, there is no approved monotherapy in the European Union, with the exception of brentuximab vedotin in refractory or recurrent large systemic anaplastic lymphomas.

Stem cell transplantation may be an option for patients who respond to a second line of treatment or a subsequent line of treatment, but conditions for being eligible for transplantation, including long-term remission, are infrequent.

Brentuximab vedotin (BV) is a targeted treatment directed against a protein, cluster of differentiation antigen 30 (CD30), present on the surface of lymphoma cells. It allows chemotherapy to enter directly into the lymphoma cell. The CD30 protein is variably expressed in patients with relapsed or refractory T-cell lymphoma; about 50% of patients have significant expression.

Data from clinical studies with brentuximab vedotin suggest that the addition of this treatment to gemcitabine may be more successful than gemcitabine alone.

The main hypothesis is a 15% increase in responder patients after 4 cycles of treatment with brentuximab vedotin and gemcitabine. The main objective of the study is therefore to determine the overall response rate after 4 cycles of treatment according to the criteria of Lugano 2014 (response based on CT-scan).

The secondary objectives will focus on the efficacy of brentuximab vedotin: complete response rate, response time for responder patients, time to failure of treatment, time to next treatment and overall survival, efficacy of brentuximab vedotin maintenance: survival progression-free, response time, overall survival, overall response rate based on positron emission tomography (PET)-scan and brentuximab vedotin toxicity in patients treated with gemcitabine and in maintenance therapy.

The duration of the study is estimated to be 4.5 years including follow-up with an estimated recruitment period of 1.5 years. 70 patients will be enrolled.

Being tested
Brentuximab Vedotin - induction, Gemcitabine, Brentuximab Vedotin - maintenance, autologous or allogeneic stem cell transplantation
Keywords
Brentuximab Vedotin, T-cell lymphoma
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab Vedotin - inductionDrug

    Also called Adcetris

    Brentuximab vedotin 1.8 mg/kg at D8 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 1000 mg/m² at D1 and D15 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy

  • Brentuximab Vedotin - maintenanceDrug

    Also called Adcetris

    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

  • autologous or allogeneic stem cell transplantationProcedure or surgery

    Patients who will obtain partial or complete response and who will be eligible for transplant will receive autologous or allogeneic stem cell transplantation

Study groups in NCT03496779
Study groupRoleWhat they receive
ExperimentalExperimentalPatients 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.
Receives: Drug: Brentuximab Vedotin - induction; Drug: Gemcitabine; Drug: Brentuximab Vedotin - maintenance; Procedure: autologous or allogeneic stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

Secondary outcomes (12)

  1. Progression-Free Survival (PFS)

    % of patient who did not progressed according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

  2. Progression-Free Survival (PFS)

    % of patient who did not progressed according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

    Measured: 4.5 years

  3. Complete Response Rate (CRR)

    rate of patient in Complete Response (CR)according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

  4. Duration of Response (DoR)

    duration between the Complete/Partial Response and the Progression according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response) = duration between the Complete/Partial Response and the Progression

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

  5. Duration of Response (DoR)

    duration between the Complete/Partial Response and the Progression according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response) = duration between the Complete/Partial Response and the Progression

    Measured: 4.5 years

  6. Time to Treatment Failure (TTF)

    duration between the inclusion and the premature end of treatment

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

  7. Time to next treatment

    Duration between the end of the studied treatment and the beginning of a new one after progression

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

  8. Overall Survival (OS)

    % of patient still alive

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

  9. Overall Survival (OS)

    % of patient still alive

    Measured: 4.5 years

  10. Overall response rate

    rate of patient in Complete/Partial response according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

    Measured: 4.5 years

  11. Number of Serious Adverse Events (SAE) during the induction period

    Measured: 16 weeks = 4 cycles or permanent treatment discontinuation

  12. Number of Serious Adverse Events (SAE) during the maintenance period

    Measured: 36 weeks = 12 cycles or permanent treatment discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start10 Apr 2018
  3. Primary completion31 Jan 2020
  4. Study completion8 Oct 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is an open label, multicenter phase 2 study. Patients treated with gemcitabine will receive brentuximab vedotin (GBv) for 4 cycles of induction.
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03496779
Sponsor's protocol ID
TOTAL
Status last verified
Jul 2025
First submitted
5 Apr 2018
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40758949

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab Vedotin - induction, Gemcitabine and Brentuximab Vedotin - maintenance in people with Refractory Peripheral T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 39 sites in 2 countries.

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 11 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in France, Belgium. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Response Rate (ORR) (time frame: 16 weeks = 4 cycles or permanent treatment discontinuation). 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 NCT03496779, which also lists 1 linked publication.

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 30 Jul 2025.

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