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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    148
  • sponsor
    Innate Pharma
Updated on 21 November 2020
ct scan
lymphoma
flow cytometry
skin lesion
systemic therapy
fungal infection
oxaliplatin
neutrophil count
beta-hcg
skin biopsy
t-cell lymphoma
peripheral t-cell lymphoma
angioimmunoblastic t-cell lymphoma
mycosis fungoides
sezary syndrome
anaplastic large cell lymphoma
large cell lymphoma
mycosis

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.

Details
Treatment IPH4102, Gemcitabine + Oxaliplatin
Clinical Study IdentifierNCT03902184
SponsorInnate Pharma
Last Modified on21 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Peripheral T-Cell Lymphoma or cutaneous T-cell lymphoma or Mycosis Fungoides/Sezary Syndrome?
Do you have any of these conditions: Mycosis Fungoides/Sezary Syndrome or Peripheral T-Cell Lymphoma or t cell lymphoma or cutaneous T-cell lymphoma or T-Cell Lymphoma?
Do you have any of these conditions: t cell lymphoma or cutaneous T-cell lymphoma or Mycosis Fungoides/Sezary Syndrome or T-Cell Lymphoma or Peripheral T-Cell Lymphoma?
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
Feasibility of obtaining at least one skin biopsy at screening
Cohorts 2 and 3
\. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF
\. KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) in at least one
skin lesion based on central evaluation by IHC
\. Patients should have received at least two prior systemic therapies
\. 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, except for
mogamulizumab, a wash-out period of at least 8 weeks is required
\. Patients should have recovered from all non-hematological adverse events
related to prior therapy to grade 1 except for alopecia
\. Adequate baseline laboratory data
Hematology
Hemoglobin >9 g/dL
Absolute neutrophil count (ANC) 1,500/L
Platelets 100,000/L
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. Adequate methods are described in Appendix 11; 16. 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
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. Inhaled steroids are allowed provided the presence of a concomitant medical condition that justifies the use
Receipt of live vaccines within 4 weeks prior the 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
Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents, extracorporeal photopheresis (ECP) or immunotherapy
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 active Hepatitis B or C virus infection
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
Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria
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
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