Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL
2022년 2월 10일 업데이트: Junning Cao, MD, Fudan University
PI3Kδ Inhibitor Parsaclisib in Combination With Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in Participants With Previously Untreated Peripheral T-cell Lymphoma
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL).
연구 개요
상세 설명
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL) by conducting in two stages, dose-escalation stage and dose-expansion stage.
In dose-escalation stage, patients with treated-naïve PTCL will be assigned to receive sequentially higher doses of parsaclisib range from 10 to 20mg po, qd plus CHOP (21 days per cycle).
The dose escalation will follow the classic 3+3 design.
The recommended phase 2 dose (RP2D) of parsaclisib will be determined according to the dose-escalation results.
In dose-expansion stage, additional patients will be recruited to receive Par-CHOP for the planned 6 cycles or until disease progression, unacceptable drug-related adverse events or starting new anti-lymphoma treatments.
연구 유형
중재적
등록 (예상)
30
단계
- 2 단계
- 1단계
연락처 및 위치
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연구 연락처
- 이름: Junning Cao
- 전화번호: +86-21-64175590
- 이메일: cao_junning@126.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 1. Subjects fully understand and voluntarily participate in this study and sign informed consent
- 2. Age≥18, ≤70 years
- 3. Histologically confirmed diagnosis of treatment-naïve PTCL, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL, ALK+ALCL with IPI≥2, no limitation with ALC-ALCL), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma, hepatosplenic T-cell, γ/δ T-cell lymphoma; Other PTCL that investigators consider to be appropriate to be enrolled.
- 4. No previous systemic treatment before enrollment.
- 5. At least one measurable lesions according to LUGANO 2014 criteria.
- 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- 7. Life expectancy ≥3 months.
- 8. Ineligible or decline to receive autologous stem cell transplantation (ASCT).
- 9. Adequate main organ function defined as the following required baseline laboratory data: Absolute neutrophil count (ANC)≥1.5×109/L without given G-CSF within 14 days; Platelet count (PLT)≥75×109/L without given transfusion with 14 days; Hemoglobin (HB)≥8g/dL without given transfusion or erythropoietin; Total bilirubin (TBIL)≤1.5X upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5X ULN; Serum creatinine (Scr)≤1.5X ULN; Left ventricular ejection fraction (LVEF)≥50%; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age was defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
- 10.If there is a risk of pregnancy, all participants (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% for entire treatment period up to 120 days after the last dose of investigational drug (or 180 days after chemotherapeutic drug).
Exclusion Criteria:
- 1. Current or previous history of other malignancies within 5 years prior to study enrollment.
- 2. Current diagnosis of any of the following: Adult T-cell leukemia/lymphoma, precursor cell lymphoblastic leukemia/lymphoma, extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), indolent cutaneous T-cell lymphoma (CTCL).
- 3. Target lesions were treated with radiotherapy within 4 weeks of enrollment.
- 4. Patients undergo interventional clinical trials.
- 5. Concurrent lymphoma with CNS invasion.
- 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- 7. Known allergy to the active ingredients or excipients of IBI376 and CHOP regimens.
- 8. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- 9. Positive test results for HBsAg antigen and HBV-DNA, or hepatitis C virus (HCV) antibody.
- 10. Received live vaccine within 30 days prior to initial investigational drug administration (day 1 of cycle 1) (Note: inactivated virus vaccine for injection is allowed within 30 days prior to initial administration, but live attenuated vaccine is not allowed).
- 11. Pregnant or breastfeeding women.
- 12. Any serious uncontrolled systemic disease.
- 13. Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: PI3Kδ inhibitor Parsaclisib plus CHOP
Phase Ib (Explored the appropriate dose of Parsaclisib in combination with CHOP) Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. CHOP was given at the standard dose, 21 days per cycle Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib day 1-14 of each cycle, as well as CHOP at standard dose for 6 cycles. Maintain treatment: Parsaclisib maintenance (2.5mg po, qd) will be performed on CR or PR patients after 6 cycles of induction therapy until disease progression, death, unacceptable toxicity, withdrawal of informed consent, or the investigator's decision or initiation of new antitumor therapy. The maximum maintenance period of parsaclisib is 24 months. |
Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib. Maintain treatment: 2.5mg orally every day continuously, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years.
다른 이름들:
Cyclophosphamide: 750mg/m2, IV, d1 Doxorubicin: 50mg/m2, IV, d1 Vincristine: 1.4mg/m2, IV, d1 (maximum 2mg) Prednison: 100mg, po, d1-5 21 days per cycle
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-year EFS
기간: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
|
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
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From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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혈액학 및 비혈액학 독성
기간: 치료기간 전체, 최대 6개월
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CTCAE v5.0에 의해 평가된 치료 관련 부작용이 있는 참가자 수
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치료기간 전체, 최대 6개월
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CRR
기간: at the end of Cycle 6 (each cycle is 21 days)
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the ratio of numbers of patients with complete response to all the participants receiving treatment
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at the end of Cycle 6 (each cycle is 21 days)
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ORR
기간: at the end of Cycle 6 (each cycle is 21 days)
|
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
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at the end of Cycle 6 (each cycle is 21 days)
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EFS
기간: From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
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the period from the date of patients sign informed consent to the observed event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment
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From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
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OS
기간: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
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time between the date of patients sign informed consent and the date of death or the date of last follow-up time
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From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Junning Cao, Fudan University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2022년 3월 1일
기본 완료 (예상)
2025년 3월 1일
연구 완료 (예상)
2025년 12월 1일
연구 등록 날짜
최초 제출
2022년 1월 28일
QC 기준을 충족하는 최초 제출
2022년 2월 10일
처음 게시됨 (실제)
2022년 2월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 2월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 2월 10일
마지막으로 확인됨
2022년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PTCL-2022-01
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .