jRCT2031200357招募中不适用
A Phase 1b/2 Study of Tafasitamab, Tafasitamab Plus Lenalidomide, Tafasitamab Plus Parsaclisib, and Tafasitamab Plus Lenalidomide in Combination With R-CHOP in Japanese Participants With Non-Hodgkin Lymphoma (J-MIND)
Incyte Biosciences Japan G.K.0 个研究点目标入组 65 人开始时间: 2020年12月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Groups 1 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL.
- •Groups 3, 4a and 5 only: Biopsy-proven participants with relapsed or refractory DLBCL.
- •Groups 2 and 6 only: Biopsy-proven participants with DLBCL and another select lymphoid neoplasms.
- •Participants must have at least 1 bi-dimensionally measurable lesion.
- •ECOG performance status of 0 to
- •Participants with protocol defined laboratory criteria at screening as defined in the protocol.
- •Groups 1 only:
- •Received at least 1 previous systemic therapy line for the treatment of NHL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
- •Groups 2, 3, 4a, and 6 only:
- •Received at least 1, but no more than 3, previous systemic therapy lines for the treatment of DLBCL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
- •Group 5 only: Participant must have:
- •Untreated DLBCL.
- •Ann Arbor Stage III to IV.
- •IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only).
- •Appropriate candidate for R-CHOP.
- •LVEF of >=50%, assessed by echocardiography.
- •Willingness to avoid pregnancy or fathering children.
- •In the opinion of investigator, the participant must:
- •Not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative.
- •Be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
排除标准
- •Any other histological type of lymphoma
- •History of prior non-hematologic malignancy.
- •Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
- •Participants with known positive test result for hepatitis C, and hepatitis B.
- •Known seropositive for or history of active viral infection with HIV.
- •Known active bacterial, viral, fungal, mycobacterial, or other infection at screening.
- •Known CNS lymphoma involvement-present or past medical history.
- •History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigators opinion preclude participation in the study or compromise the participants ability to give informed consent.
- •History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •History or evidence of interstitial lung disease.
- •Vaccination with live vaccine within 21 days prior to study treatment (Note: throughout the study treatment period and at least 6 months after end of treatment, vaccination with live vaccines should be avoided).
- •Major surgery within up to 30 days prior to signing the ICF, unless the participant is recovered at the time of signing the ICF.
- •Any anticancer and/or investigational therapy within 14 days prior to the start of Cycle 1
- •Groups 2, 3, 4a, 5 and 6 only: Gastrointestinal abnormalities including the inability to take oral study treatment, requiring IV alimentation, or prior surgical procedure affecting absorption.
- •Pregnancy or lactation.
- •Groups 2, 3, 5 and 6 only: Participants who have history of deep venous thrombosis/embolism, threatening thromboembolism, stroke or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period if required
- •Group 4a only: Use or expected use during the study of any restricted medications, including potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the date of study treatment administration.
- •Groups 1, 3, 4a, 6 only: Participants who have:
- •Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.
- •In the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies.
- •Groups 1, 3 and 4a only: Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19 mAbs including bispecific and ADCs).
- •Groups 2 and 6 only: Previous treatment with tafasitamab. Note: Participants in Groups 2 and 6 who have received previous CD19 directed therapy (other than tafasitamab) must have CD19-positive lymphoma confirmed by a biopsy taken after completing the prior CD19-targeted therapy.
- •Groups 2, 3 and 6 only: Been previously treated with IMiDs (eg, thalidomide or LEN).
- •Group 4a only: Been previously treated with selective PI3Kdelta or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosine kinase inhibitors (eg, ibrutinib).
- •A history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, IMiDs, and/or the excipients contained in the study treatment formulations (citric acid monohydrate, polysorbate 20, sodium citrate dehydrate and trehalose dihydrate).
- •Undergone ASCT within the period <= 3 months before the signing of the ICF. Participants who have a more distant history of ASCT must exhibit full hematological recovery before enrolment into the study.
- •Undergone previous allogenic stem cell transplantation.
- •9.Concurrent treatment other anticancer or experimental treatments.
- •Group 5 only: Participants who have:
- •A history of radiation therapy to >= 25% of the bone marrow for other diseases or history of anthracycline therapy.
- •A history of hypersensitivity or contraindication to any component of R-CHOP, LEN, or compounds of similar biological or chemical composition as tafasitamab and/or the excipients contained in the study treatment formulations or R-CHOP.
- •Contraindication to any of the individual components of R-CHOP.
- •Any anticancer and/or investigational therapy within 30 days prior to the start of Cycle 1, except for permitted prephase treatment defined below.
结局指标
主要结局
-
- Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S) - Part 4: Objective Response
次要结局
未报告次要终点
研究者
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