NL-OMON53056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. - Celgene 0451/0182 (MEDI4736-NHL-001)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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-or other BTK-inhibitor failure or an inadequate tumor response
- •which is less than partial response;
- •e. Relapsed/progressive disease within 6 months of completing their last
- •therapy which may include investigational drug.
- •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
- •- Any time during Cycle 2 (strongly recommended), 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.
- •Note: A previously irradiated lesion is ineligible to be used as a measurable
- •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).
- •Subject who has performance status of 0, 1, or 2 on the ECOG scale.
- •10. Subject who has life expectancy of greater than 6 months.
- •11. Subject who fulfills the laboratory requirements outlined in Table 6 of the
- •12. Female subject of childbearing potential (FCBP1) who is sexually active
- •with a male must:
- •a. Have 2 negative pregnancy tests as verified by the investigator prior to
- •starting any IP therapy. They must agree to ongoing pregnancy testing during
- •the course of the study, and after the last dose of any IP. This applies even
- •if the subject practices true abstinence from heterosexual contact.
- •b. Use effective methods (1 highly effective and 1 additional effective
- 另有 7 项未显示
排除标准
- •ALL TREATMENT ARMS
- •1. Subject who has known or suspected central nervous system (CNS) or meningeal
- •involvement by lymphoma.
- •2. Subject who has other lymphoma histologies which are not listed on Table
- •3, Table 4, or Table 5 of the protocol.
- •a. Subject who has blastoid variants of MCL or MCL with blastoid transformation.
- •b. Dose Confirmation and/or Expansion Parts only:
- •- Transformed lymphoma or Richter's transformation
- •- DLBCL histology other than: not otherwise specified or T-cell/histiocyte rich.
- •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
- •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
- •8. Subject who is concurrently enrolled in another clinical study, unless in a
- •follow-up period or it is an observational study.
- •9. Subject who has any concurrently chemotherapy, immunotherapy, biologic, or
- •hormonal therapy for cancer treatment.
- •10. Subject who has received:
- •a) Any systemic antilymphoma/leukemia therapy, or hematopoietic growth factors,
- •blood or platelets transfusions within 14 days prior to the first dose of IP
- •(ie, Cycle1 Day 1) and/or
- •b) Any radioimmunotherapy within 3 months prior to the first dose of IP (ie,
- •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 fist
- •dose of IP (ie,Cycle 1 Day 1), unless administered at a dose equivalent to <= 10
- •mg/day prednisone. See protocol for exceptions.
- •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 for 12 monhts after last dose of rituximab or
- •until recovery of B-cells and for 120 days after the last dose of durvalumab,
- •whichever is longer).
- •16. Subject who has undergone major surgical procedure (as defined by the
- 另有 5 项未显示
研究者
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