Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)

Launched by INNATE PHARMA · Oct 29, 2015

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with relapsed/refractory, biopsy-proven primary cutaneous T-cell lymphoma who have received at least two previous standard systemic therapies and, if MF/SS, is stage IB IVB at study entry.
• • 2. Centrally assessed KIR3DL2 expression on tumor cells.
• 3. Patients must have the following minimum wash-out from previous treatments:
• • ≥12 weeks for total skin electron beam irradiation,
• • ≥4 weeks for monoclonal antibodies (≥8 weeks for alemtuzumab),
• • ≥3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-neoplastic investigational agents
• • ≥3 weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion proteins
• • ≥3 weeks for phototherapy
• • ≥2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or imiquimod) Topical steroids (maximum strength: medium potency) and oral steroids (≤10 mg prednisone equivalent/day) are allowed, if the patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.
• • 4. At least 18 years of age.
• • 5. ECOG performance status of ≤2.
• • 6. Adequate baseline laboratory data: hemoglobin \>9 g/dL, absolute neutrophil count (ANC) ≥1,000/µL, CD4+ T-cells ≥200/µL, platelets ≥50,000/µL, 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) ≤3 X ULN.
• • 7. Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy test result within seven days of treatment and must practice an effective method of contraception during treatment and for at least 9 months (270 days) following the last dose of study drug.
• • 8. Female patients who are post-menopausal or surgically sterile.
• • 9. Male patients who agree to practice effective barrier contraception.
• • 10. Ability to understand and the willingness to sign a written informed consent document.
• • 11. No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Exclusion Criteria:
• • 1. Patients with limited disease (if MF/SS: stages IA) or central nervous system (CNS) disease.
• • 2. Clinical relevant AEs or laboratory results related to previous anti-neoplastic therapy have not resolved to a NCI-CTCAE grade ≤1.
• • 3. Concomitant corticosteroid use, systemic or topical, for treatment of skin disease. However, topical steroids (maximum strength: medium potency) and oral steroids (≤10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.
• • 4. Patients who have undergone major surgery \<4 weeks prior to starting study drug.
• • 5. Patients who have undergone a stem cell transplantation.
• • 6. Patients with known NCI CTCAE Grade 3 or higher (requiring IV antibiotics) active systemic or cutaneous viral, bacterial, or fungal infection.
• • 7. Patients who are Hepatitis B or Hepatitis C antibody positive.
• • 8. Patients who are known to be HIV-positive.
• • 9. Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy.
• • 10. Patients with a history of other malignancies during the past three years. (The following are exempt from the three-year limit: non-melanoma skin cancer, Lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ).
• • 11. Patients who are currently pregnant or breastfeeding.
• • 12. Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
• • 13. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
• • 14. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.