EUCTR2015-003516-21-IT进行中（未招募）1 期
A Phase 1/2, open label, multicenter study to assess the safety and tolerability of durvalumab (anti-PD-L1 antibody) as monotherapy and in combination therapy in subjects with lymphoma or chronic lymphocytic leukemia. The FUSION NHL 001 Study. - A study to assess the safety and tolerability of durvalumab as monotherapy and in combination therap
CELGENE INTERNATIONAL II SàR0 个研究点目标入组 265 人开始时间: 2021年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 265
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
- •ALL TREATMENT ARMS
- •1. Subject is = 18 years of age and = 80 years of age at the time of signing the ICF. Subjects > 80 years of age may be included if they meet criteria defined in the protocol.
- •2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- •3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •4. Subject has histologically confirmed and documented eligible histologies as defined in the protocol.
- •5. Subject has been previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
- •6. Subject with high-risk CLL/SLL is defined by the presence of at least one of the following factors:
- •a. Complex karyotype;
- •b. del (17p) abnormality;
- •c. Mutated TP53;
- •d. Ibrutinib-failure or an inadequate tumor response which is less than partial response;
- •e. Relapsed/progressive disease within 6 months of completing their last therapy.
- •7. Subject is willing and able to undergo biopsy:
- •a. Subject with lymphoma is willing and able to undergo tumor/lymph node biopsy (incisional/excisional or multiple core needle) during the Screening Period and at the time of disease progression from subjects who have achieved objective response (CR/PR) to study treatment.
- •b. Subject with CLL is willing and able to undergo bone marrow biopsy during the Screening and Treatment Periods.
- •Material from a fine needle aspiration is not acceptable.
- •8. Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
- •9. Subject who has measurable disease:
- •a. For subject with lymphoma, bi-dimensionally measurable disease on cross-sectional imaging by computed tomography (CT) with at least one nodal or extranodal lesion =2.0 cm in its longest dimension.
- •b. For subject with CLL, in need of treatment as defined by IWCLL Guidelines for the Diagnosis and Treatment of CLL (Appendix I of protocol).
- •10. Subject who has performance status of 0, 1, or 2 on the ECOG scale.
- •11. Subject who has life expectancy of greater than 6 months.
- •12. Subject who fulfills the laboratory requirements outlined in Table 6 of the protocol.
- •See protocol for inclusion criteria 13 and 14
- •See protocol for inclusion criteria specific to Arms A, B and C.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 106
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 159
排除标准
- •ALL TREATMENT ARMS
- •1. Subject has known or suspected central nervous system (CNS) or meningeal involvement by lymphoma.
- •2. Subject has other lymphoma histologies which are not listed on Table 3, Table 4, or Table 5 of the protocol.
- •a. Subject has blastoid variants of MCL or MCL with blastoid transformation.
- •b. Dose Confirmation and Expansion Parts only: Subject has transformed lymphoma or Richter’s transformation.
- •3. Subject who has any histopathologic finding consistent with myelodysplastic syndrome on bone marrow studies.
- •4. Subject who has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •5. Subject who has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •6. Subject who has any condition that confounds the ability to interpret data from the study.
- •7. Subject who has any uncontrolled inter-current illness as defined in the protocol.
- •8. Subject who is concurrent enrolled in another clinical study, unless in a follow-up period or it is an observational study.
- •9. Subject who has any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
- •10. Subject who has received any systemic antilymphoma/leukemia therapy, or hematopoietic growth factors, blood or platelets transfusions within 14 days prior to the first dose of IP. (Refer to protocol for exceptions).
- •11. Subject who has unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 = Grade 1 with the exception of alopecia and laboratory values listed per the exclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab or other investigational treatments may be included (eg, hearing loss) after consultation with the sponsor’s medical monitor.
- •12. Subject who received any prior mAb against PD-1 or PD-L1 and/or any prior:
- •a. Arm A only: IMiDs (eg, lenalidomide, thalidomide);
- •b. Arm B only: ibrutinib or other BTK inhibitor;
- •c. Arms C only: bendamustine.
- •13. Subject who has history of organ transplant or allogeneic hematopoietic stem cell transplantation.
- •14. Subject who has taken corticosteroids during the last 1 week prior to Cycle 1 Day 1, unless administered at a dose equivalent to = 10 mg/day prednisone.
- •15. Subject who has received live, attenuated vaccine within 30 days prior to the first dose of durvalumab (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and 30 days after the last dose of durvalumab).
- •16. Subject who has undergone major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of the IP or still recovering from prior surgery.
- •17. Subject who has active documented autoimmune disease prior to first dose of durvalumab.
- •18. Subject who has history of primary immunodeficiency or tuberculosis.
- •19. Subject who has known seropositivity for or active infection for human immunodeficiency virus or hepatitis C virus.
- •20. Subject who is seropositive for or active viral infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
- •Exceptions:
- •a. Antibody to the hepatitis B surface antigen (anti-HBs) positive only with prior HBV vaccination history.
- •b. Anti-HBs positive (no prior HBV vaccination) and/or antibody to the hepatitis B core ant
研究者
相似试验
进行中（未招募）
1 期
A study to assess the safety and tolerability of durvalumab as monotherapy and in combination therapy in people with lymphoma or chronic lymphocytic leukemiaEUCTR2015-003516-21-DECelgene International II Sàrl265
招募中
2 期
A Phase 1/2, open label, multicenter study to assess the safety and tolerability of durvalumab (anti-PD-L1 antibody) as monotherapy and in combination therapy in subjects with lymphoma or chronic lymphocytic leukemia. (MEDI4736-NHL-001). The *FUSION NHL 001* Study.10025322lymph node cancer10024324leukemiaNL-OMON53056Celgene Corporation15
进行中（未招募）
1 期
A study to assess the safety and tolerability of durvalumab as monotherapy and in combination therapy in people with lymphoma or chronic lymphocytic leukemiaEUCTR2015-003516-21-GBCelgene International II Sàrl265
进行中（未招募）
1 期
A study to assess the safety and tolerability of durvalumab as monotherapy and in combination therapy in people with lymphoma or chronic lymphocytic leukemiaRelapsed/refractory (R/R) lymphoma or R/R chronic lymphocytic leukemia (CLL) previously treated with at least one systemic therapyMedDRA version: 20.0Level: HLTClassification code 10029592Term: Non-Hodgkin's lymphomas NECSystem Organ Class: 100000004851EUCTR2015-003516-21-NLCelgene International II Sàrl265
招募中
1 期
A phase 1/2 open-label, multicenter study to assess the safety, pharmacokinetics and anti-tumor activity of GTAEXS617 in patients with advanced solid tumorsCTIS2023-508227-13-00Exscientia AI Limited177