Trial Search Results

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

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, and in patients with peripheral T-cell lymphoma in combination with gemcitabine and oxaliplatin chemotherapy (GEMOX)

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Innate Pharma

Stanford Investigator(s):

Intervention(s):

  • Biological: IPH4102
  • Drug: Gemcitabine + Oxaliplatin

Phase:

Phase 2

Eligibility


Inclusion Criteria:

- Cohort 1:

   1. Patients with relapsed/refractory Sezary Syndrome (SS) who have received at least 2
   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 1 skin biopsy at screening.

   - Cohorts 2 and 3:

   5. Patients with stage IB to IV Mycosis fongoïdes (MF);

   6. KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) by immunohistochemistry
   performed centrally on at least one skin lesion;

   7. Patients should have received at least 2 prior systemic therapies that may include
   biological agents;

   8. Feasibility of obtaining at least 1 skin biopsy at screening;

   9. Adequate baseline laboratory data: Hematology: CD4+ T-cells ≥ 200/μL.

   - Cohorts 4 and 5:

10. Patients with relapsed/refractory Peripheral T Cell Lymphoma (PTCL) of the following
   subtypes:

   PTCL-NOS, angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large cell lymphoma
   (ALCL);

11. KIR3DL2 expression (Cohort 4) or non-expression (Cohort 5) by immunohistochemistry
   performed centrally on at least one involved lymph node;

12. Patients should have received at least 1 prior systemic therapy including an
   anthracycline-based chemotherapy. Patients who are not eligible for treatment with
   anthracycline based therapy are eligible for inclusion provided that they were treated
   with at least one prior systemic therapy;

13. Presence of at least 1 target lesion on PET/CT scan at screening;

14. Feasibility of obtaining 1 lymph node biopsy at screening.

   - All cohorts:

15. Male or Female, at least 18 years of age;

16. ECOG performance status ≤2;

17. The patient must have a minimum wash-out period of 4 weeks between the last dose of
   prior systemic therapy (8 weeks for biological agents) and the first dose of IPH4102

18. Patients should have recovered from all adverse events related to prior therapy to ≤
   grade 1;

19. Adequate baseline laboratory data

20. Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy
   test result within seven days from start of treatment;

21. 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.

Exclusion Criteria:

- Cohorts 1 to 3:

   1. Patients with evidence of large cell transformation (LCT) based on central histologic
   evaluation.

   - Cohorts 4 and 5:

   2. Prior administration of gemcitabine and/or oxaliplatin;

   3. Presence of grade 2 neurotoxicity or higher.

   - All Cohorts:

   4. Known central nervous system (CNS) lymphoma;

   5. Prior administration of IPH4102;

   6. Concomitant administration of radiotherapy or systemic anti-cancer therapy including
   but not restricted to: chemotherapy, biological agents or immunotherapy;

   7. Autologous stem cell transplantation less than 3 months prior to enrollment;

   8. Prior allogenic transplantation;

   9. 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;

10. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;

11. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral,
   bacterial, or fungal infection;

12. Patients who have active Hepatitis B or C virus infection;

13. Patients who are known to be HIV-positive;

14. Patients with a history of other malignancies during the past 5 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 or cervical carcinoma in situ;

15. Pregnant or breastfeeding women;

16. Patients with congestive heart failure, Class III or IV, by New York Heart Association
   (NYHA) criteria;

17. Patients with known active autoimmune disease;

18. 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;

19. Patients with dementia or altered mental status that would

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sophia Fong
650-498-8604
Recruiting