EUCTR2016-002739-14-LT进行中（未招募）1 期
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients with Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
- •-Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration.
- •-Patients must have been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue).
- •-No more than 3 prior salvage therapies.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 7
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration.
- •- Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration.
- •- Clinical evidence of active central nervous system (CNS) leukemia.
- •- T-ALL with testicular involvement alone.
研究者
相似试验
进行中（未招募）
1 期
Safety and Efficacy of Isatuximab in Lymphoblastic LeukemiaHaematological malignancyMedDRA version: 19.0Level: PTClassification code 10042987Term: T-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10036543Term: Precursor T-lymphoblastic lymphoma/leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002739-14-HUSanofi-aventis recherche & développement39
进行中（未招募）
1 期
Safety and Efficacy of Isatuximab in Lymphoblastic LeukemiaMedDRA version: 21.1Level: PTClassification code 10036543Term: Precursor T-lymphoblastic lymphoma/leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10042987Term: T-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)CancerEUCTR2016-002739-14-ITSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT14
进行中（未招募）
1 期
Safety and Efficacy of Isatuximab in Lymphoblastic LeukemiaHaematological malignancyMedDRA version: 19.0Level: PTClassification code 10042987Term: T-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10036543Term: Precursor T-lymphoblastic lymphoma/leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002739-14-FISanofi-aventis recherche & développement43
进行中（未招募）
2 期
A prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myelomaMultiple MyelomaACTRN12619000362190Australasian Myeloma Research Consortium68
进行中（未招募）
1 期
A Phase 2 Study of Isatuximab in combination with Bortezomib, Cyclophosphamide and Dexamethasone followed by isatuximab and lenalidomide maintenance in Newly Diagnosed Patients with Multiple Myeloma and severe Renal Impairmentnewly diagnosed patients with multiple myeloma and severe renal impairmentMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2021-004895-32-GRHellenic Society of Hematology (EAE)51