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IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma (TELLOMAK)

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ClinicalTrials.gov Identifier: NCT03902184
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Innate Pharma

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE May 22, 2019
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Progression free survival (PFS) (All cohorts) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
  • Overall survival (OS) (All cohorts) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
  • PK parameters : Maximum Plasma Concentration 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)
  • PK parameters :Trough Concentration 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
  • 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).
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Progression free survival (PFS) (All cohorts) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
  • Overall survival (OS) (All cohorts) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
  • 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)
  • 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
  • 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).
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma
Official Title  ICMJE TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Mycosis Fungoides/Sezary Syndrome
Intervention  ICMJE
  • Biological: IPH4102
    Patients will receive a flat dose of 750mg
    Other Name: lacutamab
  • 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 Name: GEMOX
Study Arms  ICMJE
  • 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.
    Intervention: Biological: IPH4102
  • 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.
    Intervention: Biological: IPH4102
  • 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.
    Intervention: Biological: IPH4102
  • 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

    Interventions:
    • Biological: IPH4102
    • Drug: Gemcitabine + Oxaliplatin
  • 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

    Interventions:
    • Biological: IPH4102
    • Drug: Gemcitabine + Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2023
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 lacutamab/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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hatem A Azim, MD,PhD +33484903084 Hatem.ABDELAZIM@innate-pharma.fr
Contact: Christine Paiva +33484903084 christine.paiva@innate-pharma.fr
Listed Location Countries  ICMJE France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03902184
Other Study ID Numbers  ICMJE IPH4102-201
2018-003969-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innate Pharma
Study Sponsor  ICMJE Innate Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innate Pharma
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP