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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    166
  • sponsor
    Innate Pharma
Updated on 11 July 2022
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
Condition Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides/Sezary Syndrome
Treatment IPH4102, Gemcitabine + Oxaliplatin
Clinical Study IdentifierNCT03902184
SponsorInnate Pharma
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

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
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
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
Adequate baseline laboratory data
Absolute neutrophil count (ANC) ≥1,500/µL
Platelets ≥100,000/µL
Hematology
Hemoglobin >9 g/dL
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
Biochemistry
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
Central nervous system (CNS) lymphoma involvement
Prior administration of IPH4102
Receipt of live vaccines within 4 weeks prior to treatment
Autologous stem cell transplantation less than 3 months prior to enrollment
Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study
Prior allogenic transplantation
Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection
Patients who have undergone major surgery ≤ 4 weeks prior to study entry
Known or tested positive for human immunodeficiency virus (HIV)
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
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 autoimmune disease on systemic immunosuppressive treatment
Known clinically significant cardiovascular disease or condition, including
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
Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification
Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document
Any uncontrolled arrhythmia (per the investigator's discretion)
Uncontrolled hypertension (per the investigator's discretion)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note