ClinicalTrials.gov

History of Changes for Study: NCT03902184
IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma (TELLOMAK)
Latest version (submitted July 13, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 2, 2019 None (earliest Version on record)
2 April 3, 2019 Outcome Measures and Study Status
3 May 21, 2019 Recruitment Status, Study Status, Contacts/Locations, Eligibility and Oversight
4 September 30, 2019 Study Status and Contacts/Locations
5 February 21, 2020 Contacts/Locations, Study Status, Eligibility, Arms and Interventions and Study Identification
6 November 10, 2020 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Eligibility, Study Design, Conditions and Study Description
7 May 28, 2021 Contacts/Locations, Outcome Measures, Study Status and Eligibility
8 June 16, 2022 Contacts/Locations, Study Status, Arms and Interventions, Eligibility and Study Design
9 February 2, 2023 Contacts/Locations and Study Status
10 July 13, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Changes (Merged) for Study: NCT03902184
April 2, 2019 (v1) -- July 13, 2023 (v10)

Changes in: Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: IPH4102-201
Brief Title: IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma (TELLOMAK)
Official Title: TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH 4102 4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma
Secondary IDs: 2018-003969-33 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2019 July 2023
Overall Status: Not yet recruiting Active, not recruiting
Study Start: April 1 May 22, 2019
Primary Completion: March 1 October 31, 2022 2023 [Anticipated]
Study Completion: March 1 October 31, 2023 2024 [Anticipated]
First Submitted: March 14, 2019
First Submitted that
Met QC Criteria:
April 2, 2019
First Posted: April 3, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
April 2, 2019 July 13, 2023
Last Update Posted: April 3 July 14, 2019 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Innate Pharma
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent , and in patients with peripheral T-cell lymphoma in combination with gemcitabine and oxaliplatin chemotherapy (GEMOX) .
Detailed Description:
Open or close this module Conditions
Conditions: Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Mycosis Fungoides/Sezary Syndrome
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 5 4
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 250 [Anticipated] 170 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort 1: Relapsed/refractory Sezary Syndrome
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Names:
  • lacutamab
Experimental: Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Names:
  • lacutamab
Experimental: Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non- expressing expressing (closed)
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Names:
  • lacutamab
Experimental: Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Names:
  • lacutamab
Experimental: Cohort 4: Peripheral T-cell lymphoma, KIR3DL2 expressing

IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

GEMOX will be administered every 2 weeks for a maximum of 8 cycles

Biological: IPH4102
Patients will receive a flat dose of 750mg
Drug: Gemcitabine + Oxaliplatin
Patients will receive a dose ranging from 800-1000 mg/m2 of gemcitabine and 75-100mg/m2 of oxalipatin, according to local practice .
Other Names:
  • GEMOX
Experimental: Cohort 5: Peripheral T-cell lymphoma, KIR3DL2 non-expressing

IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

GEMOX will be administered every 2 weeks for a maximum of 8 cycles

Biological: IPH4102
Patients will receive a flat dose of 750mg
Drug: Gemcitabine + Oxaliplatin
Patients will receive a dose ranging from 800-1000 mg/m2 of gemcitabine and 75-100mg/m2 of oxalipatin, according to local practice .
Other Names:
  • GEMOX
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective Response Rate (ORR)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

Using the Olsen (2011, JCO) criteria ( Cohorts 1-3 All cohorts) , or Lugano Criteria (Cohorts 4-5)
Secondary Outcome Measures:
1. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)
[ Time Frame: From first dose until study completion, an expected average of 2 years ]

patients with treatment-related adverse events as assessed by CTCAE v5.0
2. Quality of life (QoL) ( Cohorts 1-3 All cohorts)
[ Time Frame: Through study completion, an expected average of 2 years ]

Using the Skindex29 questionnaire to assesse the effects of skin disease on quality of life in three domains: Symptoms, Emotions, and Functioning
3. pruritus ( Cohorts 1-3 All cohorts)
[ Time Frame: Through study completion, an expected average of 2 years ]

Using Visual Analog Scale (VAS) for prutitus assessment: From 0 = No pruritus to 10 = Pruritus as bad as it could possibly be
4. ORR using blinded central review (Cohort 1)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

Using the Olsen (2011, JCO) criteria
5. Progression free survival (PFS) (All cohorts)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

6. Overall survival (OS) (All cohorts)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

7. Pharmacokinetics profile (PK) of IPH4102 alone (Cohorts1-3) or in combination with GEMOX (Cohorts 4 and 5); PK parameters : Maximum Plasma Concentration of IPH4102 alone (All cohorts)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

Maximum Plasma Concentration (Cmax) (W1, W5)
8. Pharmacokinetics profile (PK) of IPH4102 alone (Cohorts1-3) or in combination with GEMOX (Cohorts 4 and 5); PK parameters :Trough Concentration of IPH4102 alone (All cohorts)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

Trough Concentration (Ctrough) every 8 or 12 weeks
9. Immunogenicity of IPH4102 alone (Cohorts1-3) or in combination with GEMOX (Cohorts 4 and 5); Immunogenicity of IPH4102 alone (All cohorts)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

A serum sample will be collected at the specified time points for evaluation of anti-drug antibodies (ADA).
10. ORR lasting at least 4 months (ORR4) (Cohorts 1-3) Duration of Response (DOR)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

Using the Olsen (2011, JCO) criteria
11 . The impact of treatment on minimal residual disease (MRD) (Cohort 1).
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

A whole blood sample will be collected at the specified time points for evaluation of MRD
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria: criteria

SS patients (Cohort 1):

  1. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies;
  2. Prior treatment with mogamulizumab;
  3. Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
  4. Feasibility of obtaining at least one skin biopsy at screening;

    MF patients (Cohorts 2 and All comers):

  5. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;
  6. Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC;
  7. Patients should have received at least two prior systemic therapies;
  8. Feasibility of obtaining at least one skin biopsy at screening;

    Additional inclusion criteria applicable to all cohorts:

  9. Male or Female, at least 18 years of age;
  10. ECOG performance status ≤2;
  11. The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy and the first dose of IPH4102;
  12. Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia;
  13. Adequate baseline laboratory data:

    Hematology:

    • Hemoglobin >9 g/dL,
    • Absolute neutrophil count (ANC) ≥1,500/µL,
    • Platelets ≥100,000/µL,

    Biochemistry:

    • Bilirubin ≤1.5 X upper limit of normal (ULN) or ≤3 X ULN for patients with Gilbert's disease,
    • Serum creatinine ≤1.5 X ULN,
    • Creatinine clearance ≥30 mL/min, calculated with the Cockcroft & Gault formula,
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 X ULN;
  14. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12 months and capable to become pregnant. They must have a negative serum beta-HCG pregnancy test result within seven days from start of treatment;
  15. Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug;
  16. Signed informed consent form prior to any protocol-specific procedures
  • Cohort 1:
    1. Patients with relapsed/refractory Sezary Syndrome (SS) who have received at least 2 prior systemic therapies;
    2. Prior treatment with mogamulizumab;
    3. Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
    4. Feasibility of obtaining at least 1 skin biopsy at screening.

      Cohorts 2 and 3:

    5. Patients with stage IB to IV Mycosis fongoïdes (MF);
    6. KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) by immunohistochemistry performed centrally on at least one skin lesion;
    7. Patients should have received at least 2 prior systemic therapies that may include biological agents;
    8. Feasibility of obtaining at least 1 skin biopsy at screening;
    9. Adequate baseline laboratory data: Hematology: CD4+ T-cells ≥ 200/μL.

      Cohorts 4 and 5:

    10. Patients with relapsed/refractory Peripheral T Cell Lymphoma (PTCL) of the following subtypes:

      PTCL-NOS, angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large cell lymphoma (ALCL);

    11. KIR3DL2 expression (Cohort 4) or non-expression (Cohort 5) by immunohistochemistry performed centrally on at least one involved lymph node;
    12. Patients should have received at least 1 prior systemic therapy including an anthracycline-based chemotherapy. Patients who are not eligible for treatment with anthracycline based therapy are eligible for inclusion provided that they were treated with at least one prior systemic therapy;
    13. Presence of at least 1 target lesion on PET/CT scan at screening;
    14. Feasibility of obtaining 1 lymph node biopsy at screening.

      All cohorts:

    15. Male or Female, at least 18 years of age;
    16. ECOG performance status ≤2;
    17. The patient must have a minimum wash-out period of 4 weeks between the last dose of prior systemic therapy (8 weeks for biological agents) and the first dose of IPH4102
    18. Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1;
    19. Adequate baseline laboratory data
    20. Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy test result within seven days from start of treatment;
    21. Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug.

Exclusion Criteria:

  1. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening;
  2. Receipt of live vaccines within 4 weeks prior to treatment;
  3. Central nervous system (CNS) lymphoma involvement;
  4. Prior administration of IPH4102;
  5. Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study;
  6. Autologous stem cell transplantation less than 3 months prior to enrollment;
  7. Prior allogenic transplantation;
  8. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
  9. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
  10. Patients who have Hepatitis B Virus infection determined as HBsAg positive and / or Hepatitis C Virus infection determined as detection of HCV RNA in serum or plasma by a sensitive quantitative molecular method;
  11. Known or tested positive for human immunodeficiency virus (HIV);
  12. Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ
  13. Pregnant or breastfeeding women;
  14. Known clinically significant cardiovascular disease or condition, including:
    • Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification;
    • Any uncontrolled arrhythmia (per the investigator's discretion);
    • Uncontrolled hypertension (per the investigator's discretion).
  15. Patients with autoimmune disease on systemic immunosuppressive treatment;
  16. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;
  17. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
  • Cohorts 1 to 3:
    1. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation.

      Cohorts 4 and 5:

    2. Prior administration of gemcitabine and/or oxaliplatin;
    3. Presence of grade 2 neurotoxicity or higher.

      All Cohorts:

    4. Known central nervous system (CNS) lymphoma;
    5. Prior administration of IPH4102;
    6. Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents or immunotherapy;
    7. Autologous stem cell transplantation less than 3 months prior to enrollment;
    8. Prior allogenic transplantation;
    9. Concomitant corticosteroid use, systemic or topical. However, stable dosage of topical steroids (maximum strength Class III according to World Health Organization (WHO) Classification of Topical Corticosteroids) and/or systemic steroids (≤10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose for at least 4 weeks prior to treatment start;
    10. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
    11. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
    12. Patients who have active Hepatitis B or C virus infection;
    13. Patients who are known to be HIV-positive;
    14. Patients with a history of other malignancies during the past 5 years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia or cervical carcinoma in situ;
    15. Pregnant or breastfeeding women;
    16. Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria;
    17. Patients with known active autoimmune disease;
    18. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;
    19. Patients with dementia or altered mental status that would
Open or close this module Contacts/Locations
Central Contact Person: Hatem A Azim, MD,PhD
Telephone: +33430303138
Email: Hatem.ABDELAZIM@innate-pharma.fr
Central Contact Backup: Christine Paiva
Email: christine.paiva@innate-pharma.fr
Locations: United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States, 90095
Irvine Medical Center
Orange, California, United States, 92868
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
Contact:Contact: Youn Kim, MD
Stanford University
Stanford, California, United States, 94305
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
University of South Florida
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Universal Dermatology, PLLC68
Fairport, New York, United States, 14450
Columbia University Department of Dermatology
New York, New York, United States, 10032
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Contact:Contact: Pierluigi Porcu, MD
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15208
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Virginia
Inova Health Care Services
Fairfax, Virginia, United States, 22031
Austria
Universitätsklinik für Dermatologie Medizinische Universität Graz
Graz, Austria, A-8036
Medizinische Universitaet Wien
Wien, Austria, 1090
Belgium
Institut Jules Bordet
Brussel, Belgium, 1070
UZ Leuven - campus Gasthuisberg
Leuven, Belgium, 3000
Centre Hospitalier Universitaire (CHU) de Liege
Liège, Belgium, 4000
France
CHU de Bordeaux Saint André
Bordeaux, France, 33076
Contact:Contact: Marie BEYLOT-BARRY, Pr
CHU de Bordeaux Saint André
Bordeaux, France, 33075
CHRU de Tours, Hôpital Trousseau
Chambray-lès-Tours, France, 37170
CHU Henri Mondor
Créteil, France, 94010
CHRU de Lille - Hopital Claude Huriez
Lille, France, 59037
Centre Hospitalier Lyon-Sud
Lyon, France, 69495
Contact:Contact: Stephane Dalle, Pr
Centre Hospitalier Lyon-Sud
Lyon, France, 69310
Institut Paoli-Calmettes
Marseille, France, 13009
CHRU de Montpellier - Hopital Saint Eloi
Montpellier, France, 34095
Hôpital Necker-Enfants Malades
Paris, France, 75015
Contact:Contact: Morgane CHEMINANT, MD
Hôpital Saint-Louis
Paris, France, 75010
Hôpital Saint-Louis Service d'Onco-Hématologie
Paris, France, 75475
Contact:Contact: Catherine THIEBLEMONT, Pr
Hôpital Saint-Louis Service de Dermatologie
Paris, France, 75475
Contact:Contact: Martine Bagot, Pr
Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie
Rouen, France, 76031
IUCT Oncopôle
Toulouse, France, 31100
Germany
Charite - Universitaetsmedizin Berlin
Berlin, Germany, 10115
Ruhr-University Bochum
Bochum, Germany, 44791
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06120
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Universitaetsmedizin Mannheim GmbH
Mannheim,, Germany, 68167
Germany
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Contact:Contact: Rudolf Stadler, MD
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Italy
Istituto di Ematologia Lorenzo e Ariosto Seragnoli
Bologna, Italy, 40138
Contact:Contact: Pier Luigi Zinzani, MD
Institute of Hematology "Seràgnoli", Univeristy of Bologna
Bologna, Italy, 40138
ASST degli Spedali Civili di Brescia
Brescia, Italy, 25123
Istituto Dermopatico dell'Immacolata (IDI-IRCCS)
Roma, Italy, 00167
Universita di Torino
Turin, Italy, 10124
Contact:Contact: Paolo Fava, MD
Universita di Torino, Ospedale le Molinette
Turin, Italy, 10126
Poland
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii ul. Smoluchowskiego 17
Gdańsk, Poland, 80-214
CET Centrum Medyczne Pratia Poznan ul. Poznanska 14
Skorzewo, Poland, 60-185
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Ukladu Chlonnego
Warsaw, Poland, 02-781
Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clinico Universitario de Salamanca
Salamanca, Spain, 37007
Consorci Hospital General Universitari de Valencia Servicio de Dermatología
Valencia, Spain, 46014
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
United Kingdom
University of Birmingham
Birmingham, United Kingdom, B15 2TT
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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