IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma (TELLOMAK)
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| ClinicalTrials.gov Identifier: NCT03902184 |
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Recruitment Status :
Recruiting
First Posted : April 3, 2019
Last Update Posted : February 3, 2023
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Sponsor:
Innate Pharma
Information provided by (Responsible Party):
Innate Pharma
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 166 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, 2023 |
| Estimated Study Completion Date : | March 1, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Name: lacutamab |
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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.
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Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Name: lacutamab |
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Experimental: Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-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.
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Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Name: lacutamab |
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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.
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Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Name: lacutamab |
Primary Outcome Measures :
- 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 :
- 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 ]
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
SS patients (Cohort 1):
- Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies;
- Prior treatment with mogamulizumab;
- Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
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Feasibility of obtaining at least one skin biopsy at screening;
MF patients (Cohorts 2 and All comers):
- Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;
- Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC;
- Patients should have received at least two prior systemic therapies;
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Feasibility of obtaining at least one skin biopsy at screening;
Additional inclusion criteria applicable to all cohorts:
- Male or Female, at least 18 years of age;
- ECOG performance status ≤2;
- 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;
- Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia;
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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;
- 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;
- 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;
- Signed informed consent form prior to any protocol-specific procedures
Exclusion Criteria:
- Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening;
- Receipt of live vaccines within 4 weeks prior to treatment;
- Central nervous system (CNS) lymphoma involvement;
- Prior administration of IPH4102;
- Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study;
- Autologous stem cell transplantation less than 3 months prior to enrollment;
- Prior allogenic transplantation;
- Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
- Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
- 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;
- Known or tested positive for human immunodeficiency virus (HIV);
- 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
- Pregnant or breastfeeding women;
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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).
- Patients with autoimmune disease on systemic immunosuppressive treatment;
- 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;
- 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
| Contact: Innate Pharma | +33484903084 | clinical.trials@innate-pharma.fr |
Locations
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Sponsors and Collaborators
Innate Pharma
| 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: | February 3, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 Lymphoma, T-Cell, Peripheral 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 Bacterial Infections and Mycoses Infections |