Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    tellomak
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902184
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : June 2, 2021
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 June 2, 2021
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: November 10, 2020)
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 (All cohorts)
Original 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2021)
  • 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
  • Quality of life (QoL) (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
  • pruritus (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
  • 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
  • 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 (All cohorts) [ 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 (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
  • 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).
  • Duration of Response (DOR) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
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.
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
  • Mycosis Fungoides/Sezary Syndrome
Intervention  ICMJE Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Name: lacutamab
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
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: November 10, 2020)
148
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
250
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

Patients must meet all of the inclusion criteria in order to be eligible to participate in the study.

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;

    Cohorts 2 and 3:

  5. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;
  6. KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) in at least one 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,
    • 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.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria will not be eligible to participate in the study:

  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 active Hepatitis B or C virus infection;
  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. Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria;
  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.
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: Innate Pharma +33484903084 clinical.trials@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
Current Responsible Party Innate Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Innate Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innate Pharma
Verification Date May 2021

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