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Peripheral T Cell LymphomaPhase 2NCT04984837

Study of Lacutamab in Peripheral T-cell Lymphoma

A Phase 2 study testing Lacutamab, Gemcitabine and Oxaliplatine in people with Peripheral T Cell Lymphoma and Relapse/Recurrence, run by The Lymphoma Academic Research Organisation at 64 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lacutamab, Gemcitabine and Oxaliplatine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
64 sitesin 4 countries
Study dates
5 Oct 2021to 30 Apr 2028
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. KIR3DL2-positive with at least 1% of tumour cells positivity, before randomization, based on central evaluation by immunohistochemistry (IHC) 2. Patients with histologically documented PTCL:
  • Biopsy-proven treated PTCL defined by the WHO 2016 criteria (the biopsy at relapse is recommended but not mandatory):
  • PTCL-NOS
  • PTCL-TFH (AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype)
  • ALCL
  • ATL: acute- or lymphoma-type
Show all 11Show fewer
  • HSTL
  • EATL
  • MEITL
  • NKT
  • ANKL 3. For patients with ALCL: previously treated with brentuximab vedotin 4. Relapsed/refractory PTCL after at least one previous line of systemic based regimen of chemotherapy (no mandatory latency after the previous treatment) 5. With a maximum of 2 prior lines of systemic therapies, including autologous stem cell transplantation (ASCT is authorized in first and second line and is not counted as a unique line, even if associated to a systemic therapy) 6. Bi-dimensionally measurable disease defined by at least one single node or tumor lesion ≥ 1.5 cm assessed by CT scan 7. Signed written screening informed consent prior to KIR3DL2 screening 8. Signed written study informed consent prior to randomization 9. Aged 18 years or more with no upper age limit, at randomization 10. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3 prior to prephase treatment (if applicable), and 0 to 2 prior randomization 11. Minimum life expectancy of 3 months 12. Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method* from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatments 13. FCBP must have a negative serum or urinary pregnancy test within 28 days prior C1D1 14. Male patients and their partner (FCBP) must agree to use two reliable forms of contraception (condom for males and hormonal method for partners) from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatments

Who cannot join

  • 1. Patients with active COVID-19 infection (last positive PCR < 2 weeks before randomization) 2. Patients taking immunotherapy or chemotherapy, except short-term corticosteroids in monotherapy at a cumulated dose equivalent of prednisone ≤ 1mg/kg/day, during 7 consecutive days, within 3 weeks prior to first administration of study drug (C1D1); or prephase treatment given at investigator's discretion before randomization and for maximum 3 weeks (glucocorticosteroids, vepesid (VP16), cyclophosphamide, vincristine and prednisone (COP)) 3. Previous treatment by Gemcitabine or Oxaliplatin 4. Use of any experimental anti-cancer drug therapy within 6 weeks before randomization 5. Contraindication to any drug contained in the study treatment regimen 6. Previous allogenic hematopoietic cell transplantation 7. Positive test results for HIV and Hepatitis C Virus (HCV) (Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation) 8. Known active hepatitis B (positive Ag HBs) (if latent Hepatitis B Virus (HBV) (positive anti-HBc), patients have to be treated with Entecavir (Baraclude ®) and HBV PCR should be performed every month to allow antiviral strategy adaptation) 9. Central nervous system or meningeal involvement by lymphoma 10. Any of the following laboratory abnormalities prior randomization:
  • Absolute neutrophil count (ANC) < 1 G/L, unless neutropenia is related to PTCL
  • Platelet count < 75 G/L, unless thrombopenia is related to PTCL
  • Alkaline Phosphatases > 2.5 x upper limit of normal (ULN)
  • Serum Glutamoyl-oxaloacetate Transferase (SGOT) /Alanine aminotransferase (AST) or Serum Glutamate Pyruvate Transaminase (SGPT)/Alanine aminotransferase (ALT) > 2.5 x ULN
  • Bilirubin > 1.5 x ULN, unless SGOT/AST and SGPT/ALT > 2.5 x ULN or bilirubin elevated due to PTCL or hemolysis
  • Calculated creatinine clearance (MDRD or Cockcroft) < 40 mL/min 11. Any significant cardiovascular impairment: New York Heart Association (NYHA) Class III or IV cardiac disease, uncontrolled high blood pressure, unstable angina, myocardial infarction or stroke within the last 6 months from randomization, and cardiac arrhythmia within the last 3 months from randomization 12. Uncontrolled clinically significant intercurrent illness including, but not limited to, diabetes, ongoing active infections. Patients receiving antibiotics for infections that are under control may be included in the study 13. Concurrent malignancy or prior history of malignancies other than lymphoma unless the subject has been free of disease for ≥ 2 years, except early stage cutaneous squamous or basal cell carcinoma, localized prostate cancer, or cervical intraepithelial neoplasia 14. Major surgery within 4 weeks before randomization 15. Pregnant or lactating females

Trial locations and contacts

64 sites in 4 countries.

64 sites in 4 countries

France43 sites

  • CHU d'Amiens

    Amiens

  • CHU d'Angers

    Angers

  • CH d Avignon - Hopital Henri Duffaut

    Avignon

  • CH de la Côte Basque - Hôpital de Bayonne

    Bayonne

  • Institut Bergonié

    Bordeaux

  • CHU de Caen - Côte de Nacre - IHBN

    Caen

  • CH Métropole Savoie

    Chambéry

  • CHU de Clermont Ferrand - Estaing

    Clermont-Ferrand

  • APHP - Hôpital Henri Mondor

    Créteil

  • CHU de Dijon BOURGOGNE - Hôpital François Mitterand

    Dijon

  • CH de Dunkerque

    Dunkirk

  • CHD de Vendée

    La Roche-sur-Yon

  • CHU de Grenoble - Hôpital Albert Michallon

    La Tronche

  • Ch de Versailles - Hopital Andre Mignot

    Le Chesnay

  • CH du Mans

    Le Mans, 72000

  • CHRU de Lille - Hôpital Claude Hurriez

    Lille

  • Hôpital Saint Vincent-De-Paul

    Lille

  • Chu de Limoges - Hopital Dupuytren

    Limoges

  • Centre Leon Berard

    Lyon, 69373

  • Chu de Meaux

    Meaux

  • CHU de Montpellier

    Montpellier

  • CH de Mulhouse

    Mulhouse

  • CHU de Nancy - Brabois

    Nancy

  • CHU de Nantes - Hôtel Dieu

    Nantes

  • CHU de Nîmes

    Nîmes

  • CHR d'Orléans

    Orléans

  • APHP - Hopital Necker

    Paris

  • APHP - Hôpital de la Pitié Salpétrière

    Paris

  • APHP - Hôpital Saint Antoine

    Paris

  • APHP - Hôpital Saint Louis

    Paris

  • CH de Périgueux

    Périgueux

  • CH de Perpignan

    Perpignan

  • CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

    Pessac

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • CHU de Poitiers - Hôpital de La Milétrie

    Poitiers

  • Centre Hospitalier Annecy Genevois

    Pringy

  • CHU de Reims

    Reims

  • CHU de Rennes - Hôpital de Pontchaillou

    Rennes

  • Centre Henri Becquerel

    Rouen

  • Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne

    Saint-Etienne

  • Institut de Cancerologie Strasbourg Europe

    Strasbourg

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, 31100

  • CH de Bretagne Atlantique - Hopital Chubert

    Vannes

Other trials in France

Belgium12 sites

  • Institut Jules Bordet

    Anderlecht

  • VZW ZAS

    Antwerp

  • A. Z. Sint-Jan

    Bruges

  • Cliniques Universitaires de Bruxelles - Hôpital Erasme

    Brussels

  • Cliniques universitaires Saint-Luc - Université catholique de Louvain

    Brussels

  • Grand Hôpital de Charleroi

    Charleroi

  • UZ Antwerpen

    Edegem

  • HELORA - Hôpital de La LouvièreSite Jolimont

    Haine-Saint-Paul

  • CHU de LIEGE - Domaine Sart Tilman

    Liège

  • Clinique CHC MontLégia

    Liège

  • CHR Verviers

    Verviers

  • CHU Dinant Godinne - UCL Namur - YVOIR

    Yvoir

Other trials in Belgium

Germany5 sites

  • Charite Universitat Smedizin Berlin

    Berlin

  • GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizini

    Goettigen

  • Universitatsklinikum Halle (Saale)

    Halle

  • UNIVERSITAT LEIPZIG - Klinik fur Hamatologie, Zelltherapie und Hamostaseo

    Leipzig

  • UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

    Regensburg

Other trials in Germany

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario Fundacion Jimenez Diaz - Hematologia

    Madrid

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Hospital Clínico Universitario de Valencia

    Valencia

Other trials in Spain

About this study

Official title: A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL).

The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).

Being tested
Lacutamab, Gemcitabine, Oxaliplatine
Keywords
KIR3DL2, PTCL, T-cell Lymphoma
Medical subject headings
Lymphoma, T-Cell, Peripheral, Recurrence, Lymphoma, T-Cell

What participants receive

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

  • LacutamabDrug

    750 mg/IV

  • GemcitabineDrug

    1000 mg/m²

  • OxaliplatineDrug

    100 mg/m²

Study groups in NCT04984837
Study groupRoleWhat they receive
LacutamabExperimentalLacutamab 750 mg/IV + GEmOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase Lacutamab 750 mg/IV for a maximum of 20 additional cycles of 4 weeks during the maintenance phase
Receives: Drug: Lacutamab; Drug: Gemcitabine; Drug: Oxaliplatine
Standard of careActive comparatorGemOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase
Receives: Drug: Gemcitabine; Drug: Oxaliplatine

What is being measured

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

  1. median modified progression-free survival (mPFS) - CT-based

    time from randomization until one of the following events occurs, whichever comes first:

    1. Disease progression (PD)
    2. Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT))
    3. Relapse after achievement of CR
    4. Death due to any cause. PD and relapse will be evaluated according to Lugano 2014 criteria (CT-based).

    Measured: 5,5 years.

Secondary outcomes (34)

  1. median modified progression-free survival (mPFS) - PET-based

    Measured: 5,5 years.

  2. Number of Adverse Events

    Measured: 5,5 years.

  3. overall survival (OS)

    Measured: 5,5 years.

  4. complete response rate (CRR) Lugano 2014 criteria (CT-based)

    Measured: 5,5 years.

  5. complete response rate (CRR) Lugano 2014 criteria (PET-based)

    Measured: 5,5 years.

  6. overall response rate (ORR) Lugano 2014 criteria (CT-based)

    Measured: 5,5 years.

  7. overall response rate (ORR) Lugano 2014 criteria (PET-based)

    Measured: 5,5 years.

  8. response rate assessed by Deauville criteria

    Measured: 5,5 years.

  9. duration of response (DOR),

    1. Disease progression (PD)
    2. Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT))
    3. Relapse after achievement of CR
    4. Death due to any cause

    Measured: 5,5 years.

  10. rate of patients proceeding to allogenic stem cell transplantation

    Measured: 5,5 years.

  11. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 1 month (1 cycle)

  12. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 1 month (1 cycle)

  13. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 2 months (2 cycles)

  14. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 2 months (2 cycles)

  15. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 3 months (3 cycles)

  16. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 3 months (3 cycles)

  17. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 7 months (7 cycles)

  18. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 7 months (7 cycles)

  19. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 9 months (9 cycles)

  20. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 9 months (9 cycles)

  21. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 15 months (15 cycles)

  22. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 15 months (15 cycles)

  23. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 26 months (26 cycles)

  24. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 26 months (26 cycles)

  25. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)

    Measured: 29 months (29 cycles)

  26. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)

    Measured: 29 months (29 cycles)

  27. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 1 month (1 cycle)

  28. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 2 months (2 cycles)

  29. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 3 months (3 cycles)

  30. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 7 months (7 cycles)

  31. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 9 months (9 cycles)

  32. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 15 months (15 cycles)

  33. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 26 months

  34. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx

    Measured: 29 months

Timeline

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

  1. First posted2 Aug 2021
  2. Study start5 Oct 2021
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04984837
Sponsor's protocol ID
KILT
Status last verified
Apr 2026
First submitted
18 Jul 2021
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cheminant M, Lhermitte L, Bruneau J, Sicard H, Bonnafous C, Touzart A, Bourbon E, Ortonne N, Genestier L, Gaulard P, Palmic P, Suarez F, Frenzel L, Naveau L, Bazarbachi A, Dussiot M, Waast L, Avettand-Fenoel V, Brouzes C, Pique C, Lepelletier Y, Asnafi V, Marcais A, Hermine O. KIR3DL2 contributes to the typing of acute adult T-cell leukemia and is a potential therapeutic target. Blood. 2022 Sep 29;140(13):1522-1532. doi: 10.1182/blood.2022016765.

    PubMed 35687761

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lacutamab, Gemcitabine and Oxaliplatine in people with Peripheral T Cell Lymphoma and Relapse/Recurrence, run by The Lymphoma Academic Research Organisation at 64 sites in 4 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 7 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in France, Belgium, Germany, Spain. 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?

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?

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?

median modified progression-free survival (mPFS) - CT-based (time frame: 5,5 years.). 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 NCT04984837, 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 4 Jun 2026.

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