Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02593045|
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : January 20, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-Cell Lymphoma||Biological: IPH4102||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||April 2020|
|Actual Study Completion Date :||April 2020|
- Occurrence of Dose Limiting Toxicities (DLT) [ Time Frame: Within 2 weeks after the first administration ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Centrally assessed KIR3DL2 expression on tumor cells.
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.
- At least 18 years of age.
- ECOG performance status of ≤2.
- 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.
- 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.
- Female patients who are post-menopausal or surgically sterile.
- Male patients who agree to practice effective barrier contraception.
- Ability to understand and the willingness to sign a written informed consent document.
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patients with limited disease (if MF/SS: stages IA) or central nervous system (CNS) disease.
- Clinical relevant AEs or laboratory results related to previous anti-neoplastic therapy have not resolved to a NCI-CTCAE grade ≤1.
- 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.
- Patients who have undergone major surgery <4 weeks prior to starting study drug.
- Patients who have undergone a stem cell transplantation.
- Patients with known NCI CTCAE Grade 3 or higher (requiring IV antibiotics) active systemic or cutaneous viral, bacterial, or fungal infection.
- Patients who are Hepatitis B or Hepatitis C antibody positive.
- Patients who are known to be HIV-positive.
- Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy.
- 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).
- Patients who are currently pregnant or breastfeeding.
- Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
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
|United States, California|
|Stanford Cancer Center|
|Stanford, California, United States|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States|
|Paris, France, 75010|
|Leiden University Medical Center|
|London, United Kingdom|
|Responsible Party:||Innate Pharma|
|Other Study ID Numbers:||
|First Posted:||October 30, 2015 Key Record Dates|
|Last Update Posted:||January 20, 2021|
|Last Verified:||February 2019|
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases