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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 : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Innate Pharma

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.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Mycosis Fungoides/Sezary Syndrome Biological: IPH4102 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2023


Arm Intervention/treatment
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 Name: 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 Name: lacutamab

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
Other Name: lacutamab




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 (All cohorts)


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) (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 (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. 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. 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 (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. Duration of Response (DOR) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]


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

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.

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): NCT03902184


Contacts
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Contact: Innate Pharma +33484903084 clinical.trials@innate-pharma.fr

Locations
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Sponsors and Collaborators
Innate Pharma
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Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT03902184    
Other Study ID Numbers: IPH4102-201
2018-003969-33 ( EudraCT Number )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycoses
Lymphoma
Lymphoma, T-Cell
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin