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Trial record 1 of 1 for:    NCT04984837
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Study of Lacutamab in Peripheral T-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT04984837
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : August 19, 2022
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Brief 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 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).


Condition or disease Intervention/treatment Phase
Peripheral T Cell Lymphoma Relapse/Recurrence Drug: Lacutamab Drug: Gemcitabine Drug: Oxaliplatine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : January 30, 2025
Estimated Study Completion Date : January 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Lacutamab
Lacutamab 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
Drug: Lacutamab
750 mg/IV

Drug: Gemcitabine
1000 mg/m²

Drug: Oxaliplatine
100 mg/m²

Active Comparator: Standard of care
GemOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase
Drug: Gemcitabine
1000 mg/m²

Drug: Oxaliplatine
100 mg/m²




Primary Outcome Measures :
  1. median modified progression-free survival (mPFS) - CT-based [ Time Frame: 5,5 years. ]

    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).


Secondary Outcome Measures :
  1. median modified progression-free survival (mPFS) - PET-based [ Time Frame: 5,5 years. ]
  2. Number of Adverse Events [ Time Frame: 5,5 years. ]
  3. overall survival (OS) [ Time Frame: 5,5 years. ]
  4. complete response rate (CRR) Lugano 2014 criteria (CT-based) [ Time Frame: 5,5 years. ]
  5. complete response rate (CRR) Lugano 2014 criteria (PET-based) [ Time Frame: 5,5 years. ]
  6. overall response rate (ORR) Lugano 2014 criteria (CT-based) [ Time Frame: 5,5 years. ]
  7. overall response rate (ORR) Lugano 2014 criteria (PET-based) [ Time Frame: 5,5 years. ]
  8. response rate assessed by Deauville criteria [ Time Frame: 5,5 years. ]
  9. duration of response (DOR), [ Time Frame: 5,5 years. ]
    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

  10. rate of patients proceeding to allogenic stem cell transplantation [ Time Frame: 5,5 years. ]
  11. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 1 month (1 cycle) ]
  12. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 1 month (1 cycle) ]
  13. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 2 months (2 cycles) ]
  14. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 2 months (2 cycles) ]
  15. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 3 months (3 cycles) ]
  16. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 3 months (3 cycles) ]
  17. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 7 months (7 cycles) ]
  18. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 7 months (7 cycles) ]
  19. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 9 months (9 cycles) ]
  20. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 9 months (9 cycles) ]
  21. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 15 months (15 cycles) ]
  22. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 15 months (15 cycles) ]
  23. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 26 months (26 cycles) ]
  24. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 26 months (26 cycles) ]
  25. Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax) [ Time Frame: 29 months (29 cycles) ]
  26. Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough) [ Time Frame: 29 months (29 cycles) ]
  27. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 1 month (1 cycle) ]
  28. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 2 months (2 cycles) ]
  29. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 3 months (3 cycles) ]
  30. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 7 months (7 cycles) ]
  31. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 9 months (9 cycles) ]
  32. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 15 months (15 cycles) ]
  33. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 26 months ]
  34. Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx [ Time Frame: 29 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
      • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984837


Contacts
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Contact: Julie Assemat +33(0)272669333 kilt@lysarc.org

Locations
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Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Innate Pharma
Investigators
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Study Chair: Morgane Cheminant Lymphoma Study Association
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT04984837    
Other Study ID Numbers: KILT
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Lymphoma Academic Research Organisation:
KIR3DL2
PTCL
T-cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Recurrence
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Lymphoma, Non-Hodgkin
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs