JPRN-jRCT2031200357招募中1 期
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
eda Eiji0 个研究点目标入组 65 人开始时间: 2021年2月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Groups 1 and 2 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL.
- •- Groups 3, and 4 only: Biopsy-proven participants with relapsed or refractory DLBCL.
- •- Groups 5 only: Biopsy-proven participants with relapsed or refractory DLBCL.
- •- Group 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 2.
- •- Participants with protocol defined laboratory criteria at screening
- •- Groups 1 and 2 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 3, 4a, and 4b and 6only:
- •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:
- •a. Untreated DLBCL.
- •b. Ann Arbor Stage III to IV.
- •c. IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only).
- •d. Appropriate candidate for R-CHOP.
- •e. LVEF of >=50%, assessed by echocardiography.
- •- Willingness to avoid pregnancy or fathering children.
- •- In the opinion of investigator, the participant must:
- •a. Not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative.
- •b. 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
- •- Group 6 only: Primary refractory DLBCL
- •- 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 3, 4a, 4b, 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 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
- •- Groups 4a and 4b 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, 2, 3, 4a, and 4b only: Participants who have:
- •a. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.
- •b. In the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies.
- •c. Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19 mAbs including bispecific and ADCs).
- •d. Group 3 only: Been previously treated with IMiDs (eg, thalidomide or LEN).
- •e. Group 4a and 4b only: Been previously treated with selective PI3Kdelta or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosine kinase inhibitors (eg, ibrutinib).
- •f. 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).
- •g. 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.
研究者
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