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

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ClinicalTrials.gov Identifier: NCT02593045
Recruitment Status : Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Innate Pharma

Brief Summary:
The primary objective of this first in human study is to assess the safety and tolerability of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a Maximum Tolerated Dose (MTD).

Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma Biological: IPH4102 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Multicenter Phase I Study of IPH4102, a Humanized Anti-KIR3DL2 Monoclonal Antibody, in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: IPH4102 Biological: IPH4102



Primary Outcome Measures :
  1. Occurrence of Dose Limiting Toxicities (DLT) [ Time Frame: Within 2 weeks after the first administration ]


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:

  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.

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): NCT02593045


Locations
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United States, California
Stanford Cancer Center
Stanford, California, United States
United States, Ohio
Ohio State University
Columbus, Ohio, United States
France
Hôpital Saint-Louis
Paris, France, 75010
Netherlands
Leiden University Medical Center
Leiden, Netherlands
United Kingdom
Guy's Hospital
London, United Kingdom
Sponsors and Collaborators
Innate Pharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT02593045     History of Changes
Other Study ID Numbers: IPH4102-101
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin