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History of Changes for Study: NCT02593045
Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)
Latest version (submitted January 19, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 29, 2015 None (earliest Version on record)
2 February 23, 2016 Contacts/Locations and Study Status
3 August 29, 2016 Contacts/Locations and Study Status
4 March 2, 2017 Contacts/Locations and Study Status
5 August 7, 2018 Recruitment Status, Study Status and Contacts/Locations
6 February 11, 2019 Study Status
7 January 19, 2021 Recruitment Status, Study Status and Study Design
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Changes (Merged) for Study: NCT02593045
October 29, 2015 (v1) -- January 19, 2021 (v7)

Changes in: Study Status, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: IPH4102-101
Brief Title: Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2015 February 2019
Overall Status: Recruiting Completed
Study Start: October 2015
Primary Completion: December 2018 [Anticipated] April 2020 [Actual]
Study Completion: December 2019 [Anticipated] April 2020 [Actual]
First Submitted: October 29, 2015
First Submitted that
Met QC Criteria:
October 29, 2015
First Posted: October 30, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 29, 2015 January 19, 2021
Last Update Posted: October 30, 2015 [Estimate] January 20, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Innate Pharma
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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).
Detailed Description:
Open or close this module Conditions
Conditions: Cutaneous T-Cell Lymphoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 60 [Anticipated] 44 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: IPH4102 Biological: IPH4102
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Occurrence of Dose Limiting Toxicities (DLT)
[ Time Frame: Within 2 weeks after the first administration ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Korinna Pilz, MD
Telephone: +33 (0)4 30 30 30 15
Email: korinna.pilz@innate-pharma.fr
Central Contact Backup: Christine Paiva
Email: christine.paiva@innate-pharma.fr
Locations: United States, California
Stanford Cancer Center
Stanford, California, United States
United States, Ohio
Ohio State University
Columbus, Ohio, United States
France
Hôpital Saint-Louis
[Recruiting]
Paris, France, 75010
Contact:Contact: Martine BAGOT, MD
Contact:Principal Investigator: Martine BAGOT, MD
Hôpital Saint-Louis
Paris, France, 75010
Netherlands
Leiden University Medical Center
Leiden, Netherlands
United Kingdom
Guy's Hospital
London, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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