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Clinical Trials/EUCTR2017-003680-35-GR
EUCTR2017-003680-35-GR
Active, not recruiting
Phase 1

Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment (PARCT) - PARCT

European Organisation for Research and Treatment of Cancer (EORTC)0 sites26 target enrollmentJuly 9, 2018
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ConditionsSubtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)MedDRA version: 22.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 22.0Level: LLTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10028484Term: Mycoses fungoidesSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10042356Term: Skin and subcutaneous conditions NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: HLGTClassification code 10040790Term: Skin and subcutaneous tissue disorders NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Cancer [C04]
DrugsTecentriq

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Subtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)
Sponsor
European Organisation for Research and Treatment of Cancer (EORTC)
Enrollment
26
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 9, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
European Organisation for Research and Treatment of Cancer (EORTC)

Eligibility Criteria

Inclusion Criteria

  • •\-Male or female patients with diagnosis of CTCL (mycosis fungoides or Sézary\-Syndrome) tumor stage IIB to IVB (Ref. 12\)
  • •\-Availability of tumor sample for evaluation of PD\-L1 expression. A 4\-mm formalin\-fixed punch biopsy is recommended.
  • •\-Inadequate response or secondary treatment failure to at least 1 prior systemic therapy for CTCL according to treatment guidelines (e.g. INF\-2a or bexarotene).
  • •? Age \= 18 years old
  • •? WHO performance status 0\-1
  • •? Adequate bone marrow and organ function prior to receiving the first dose of study treatment:
  • •? Hemoglobin \> 10\.0 g/dL (\> 100 g/L) or hematocrit \> 30% (\> 0\.30 v/v);
  • •? White blood cell count \> 3\.0 x 10E9/L (\> 3000/mmE3\);
  • •? Absolute neutrophil count of \> 1\.5 x 10E9/L (\> 1500/mmE3\);
  • •? Platelet count \> 100 x 10E9/L (\> 100,000/mmE3\);

Exclusion Criteria

  • •\-Patients for whom only local therapy is indicated
  • •\-Received chemotherapy or targeted small molecule therapy within 4 weeks prior to registration
  • •\-Persistence of clinically relevant therapy\-related toxicity from previous systemic treatment. Grade 1 or 2 adverse events (AEs) are acceptable.
  • •\-Received a T cell depleting antibody (e.g. Alemtuzumab) within 3 months prior to registration.
  • •\-Prior therapy with anti\-PD1, anti\-PD\-L1, anti\-PD\-L2\.
  • •\-History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix and non\-metastatic, non\-melanoma skin cancer.
  • •\-Patients with known central nervous system (CNS) involvement with lymphoma.
  • •\-History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins.
  • •\-Known hypersensitivity to CHO cell products or any component of the atezolizumab formulation.
  • •\-History of any of the following cardiovascular conditions within 6 months prior to registration:

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapy
EUCTR2017-003680-35-DEEuropean Organisation for Research and Treatment of Cancer (EORTC)26
Active, not recruiting
Phase 1
Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapySubtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)MedDRA version: 20.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10028484Term: Mycoses fungoidesSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10042356Term: Skin and subcutaneous conditions NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: HLGTClassification code 10040790Term: Skin and subcutaneous tissue disorders NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-003680-35-ESEuropean Organisation for Research and Treatment of Cancer (EORTC)29
Active, not recruiting
Phase 1
Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapySubtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)MedDRA version: 22.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 22.0Level: LLTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10028484Term: Mycoses fungoidesSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10042356Term: Skin and subcutaneous conditions NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: HLGTClassification code 10040790Term: Skin and subcutaneous tissue disorders NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-003680-35-GBEuropean Organisation for Research and Treatment of Cancer (EORTC)26
Active, not recruiting
Phase 1
Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapySubtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)MedDRA version: 22.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: HLGTClassification code 10040790Term: Skin and subcutaneous tissue disorders NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: HLTClassification code 10028484Term: Mycoses fungoidesSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLTClassification code 10042356Term: Skin and subcutaneous conditions NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 22.0Level: LLTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025321Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-003680-35-ITEORTC AISBL/IVZW26
Active, not recruiting
Phase 1
Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapySubtypes of Cutaneous T cell ltymphoma (CTCL): Mycosis Fungoides (MF) and Sézary Syndrome (SS)MedDRA version: 22.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 22.0Level: LLTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10028484Term: Mycoses fungoidesSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10042356Term: Skin and subcutaneous conditions NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: HLGTClassification code 10040790Term: Skin and subcutaneous tissue disorders NECSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-003680-35-ATEuropean Organisation for Research and Treatment of Cancer (EORTC)29