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History of Changes for Study: NCT03902184
IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma (TELLOMAK)
Latest version (submitted June 16, 2022) 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
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Study NCT03902184
Submitted Date:  April 2, 2019 (v1)

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 IPH4102 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
Overall Status: Not yet recruiting
Study Start: April 1, 2019
Primary Completion: March 1, 2022 [Anticipated]
Study Completion: March 1, 2023 [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
Last Update Posted: April 3, 2019 [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
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 250 [Anticipated]
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
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
Experimental: Cohort 3: Stage IB-IV Mycosis Fungoides,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.
Biological: IPH4102
Patients will receive a flat dose of 750mg
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), or Lugano Criteria (Cohorts 4-5)
Secondary Outcome Measures:
1. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
[ 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)
[ 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)
[ 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 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. ORR lasting at least 4 months (ORR4) (Cohorts 1-3)
[ Time Frame: From the first dose until study completion, an expected average of 2 years ]

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

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

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

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

Trough Concentration (Ctrough) every 8 or 12 weeks
10. Immunogenicity of IPH4102 alone (Cohorts1-3) or in combination with GEMOX (Cohorts 4 and 5);
[ 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).
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:

  • 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:

  • 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, California
Stanford Cancer Center
Stanford, California, United States, 94305
Contact:Contact: Youn Kim, MD
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Contact:Contact: Pierluigi Porcu, MD
France
CHU de Bordeaux Saint André
Bordeaux, France, 33076
Contact:Contact: Marie BEYLOT-BARRY, Pr
Centre Hospitalier Lyon-Sud
Lyon, France, 69495
Contact:Contact: Stephane Dalle, Pr
Hôpital Necker-Enfants Malades
Paris, France, 75015
Contact:Contact: Morgane CHEMINANT, MD
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
Germany
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Contact:Contact: Rudolf Stadler, MD
Italy
Istituto di Ematologia Lorenzo e Ariosto Seragnoli
Bologna, Italy, 40138
Contact:Contact: Pier Luigi Zinzani, MD
Universita di Torino
Turin, Italy, 10124
Contact:Contact: Paolo Fava, MD
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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