Surovatamig를 돌연변이되지 않은 면역글로불린 중쇄 가변 영역(IGHV)을 가진 만성 림프구성 백혈병 또는 소림프구성 림프종 환자의 통합 치료제로 사용 (SOUNDTRACK-C1)
IGHV 돌연변이가 없는 만성 림프구 백혈병 또는 소림프구 림프종 환자를 대상으로 1차 유도 요법 후 Surovatamib를 공고 요법으로 투여하는 것과 관찰을 비교하는 3상, 무작위, 개방형, 다기관 연구 (SOUNDTRACK-C1)
The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is a Phase III global, randomised, open-label, multicentre study. The study will consist of 2 sequential parts- the Dose Optimisation and Safety Run-in part and the Phase-III part.
During the dose optimisation and safety run-in part, Surovatamig will be initiated in 2 dose levels. This part will help to determine the recommended phase III dose (RP3D) of Surovatamig to be used in Phase III part. Phase III would comprise of 2 arms, Arm A where the Surovatamig dose (RP3D) will be administered as a consolidation therapy (post standard of care [SOC] induction therapy) and Arm B where participants will be observed. In Phase 3 participants will be randomized in a 1:1 ratio to Arm A or Arm B.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
연구 장소
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California
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La Jolla, California, 미국, 92093
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Colorado
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Denver, Colorado, 미국, 80218
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Connecticut
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New Haven, Connecticut, 미국, 06510
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Illinois
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Chicago, Illinois, 미국, 60637
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Kansas
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Kansas City, Kansas, 미국, 66210
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Kentucky
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Louisville, Kentucky, 미국, 40207
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Maryland
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Bethesda, Maryland, 미국, 20817
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Massachusetts
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Boston, Massachusetts, 미국, 02215
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Minnesota
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Rochester, Minnesota, 미국, 55905
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New Jersey
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Basking Ridge, New Jersey, 미국, 07920
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New York
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Rochester, New York, 미국, 14642
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Ohio
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Cleveland, Ohio, 미국, 44195
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15232
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Texas
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Houston, Texas, 미국, 77030
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Edinburgh, 영국, EH4 2XU
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Hampshire, 영국, SO16 6YD
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Leeds, 영국, LS9 7TF
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London, 영국, SE5 9RS
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London, 영국, NW1 2BU
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Manchester, 영국, M20 4BX
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Nottingham, 영국, NG5 1PB
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Oxford, 영국, OX3 7LE
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Sutton, 영국, SM2 5PT
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Alberta
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Calgary, Alberta, 캐나다, T2N 5G2
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 4E6
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 2Y9
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
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Toronto, Ontario, 캐나다, M5G 2L7
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Quebec
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Montreal, Quebec, 캐나다, H3T 1E2
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Montreal, Quebec, 캐나다, H2L 4M1
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Québec, Quebec, 캐나다, G1J 1Z4
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Adapazarı, 터키 (Türkiye), 54100
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Antalya, 터키 (Türkiye), 07025
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Istanbul, 터키 (Türkiye), 34098
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Istanbul, 터키 (Türkiye), 34899
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Istanbul, 터키 (Türkiye), 34517
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Kocaeli, 터키 (Türkiye), 41380
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Mezitli, 터키 (Türkiye), 33200
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Adelaide, 호주, 5000
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Fitzroy, 호주, 3065
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Heidelberg, 호주, 3084
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Nedlands, 호주, 6009
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Perth, 호주, 6847
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Rockingham, 호주, 6168
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV.
- Treatment received and response at the end of 1L (first-line) finite therapy.
- Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion.
- ECOG performance status of 0 to 2.
- Adequate haematologic, liver, renal and cardiac function.
- Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception.
- Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms).
Exclusion Criteria:
- Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL).
- Evidence of active or history of Central Nervous System (CNS) involvement by CLL/SLL.
- History of or ongoing confirmed progressive multifocal leukoencephalopathy.
- Participants who have any concurrent or history of malignancy.
- Participants with:
- Active or uncontrolled infection (including Epstein-Barr virus-EBV) requiring systemic therapy.
- Participants with known history of Heamophagocytic lymphohistiocytosis (HLH).
- Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
- Major cardiac abnormalities.
- Prior CLL/SLL-specific therapies.
- Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition or prior allogeneic stem cell or solid organ transplant.
- Major surgical procedure.
- Known hypersensitivity to surovatamig or any of the excipients of the product.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1
Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length). |
Surovatamig will be administered as a subcutaneous injection.
다른 이름들:
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실험적: DOSRI-Surovatamig Dose 2
Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length). |
Surovatamig will be administered as a subcutaneous injection.
다른 이름들:
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실험적: Phase III-Arm A: Surovatamig SC
Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length). |
Surovatamig will be administered as a subcutaneous injection.
다른 이름들:
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간섭 없음: Phase III-Arm B: Observation
Participants will undergo observation for 24 weeks. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
기간: Up to 5 years
|
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV. |
Up to 5 years
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Phase III- Progression Free Survival (PFS)
기간: Until disease progression or death (up to 5 years)
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PFS is defined as the time from date of randomisation until disease progression or death due to any cause, whichever occur first based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria, as assessed by independent review committee (IRC). |
Until disease progression or death (up to 5 years)
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DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs
기간: Up to 5 years
|
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV. |
Up to 5 years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate (ORR)
기간: Up to 5 years
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ORR is defined as the proportion of participants achieving either a partial response (PR) or complete response (CR)/complete response with incomplete haematological recovery (CRi) based on response criteria iwCLL 2018, as assessed by IRC or investigator at any point during therapy/observation. |
Up to 5 years
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Complete Response rate (CR rate)
기간: Up to 5 years
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CR rate is defined as the proportion of participants achieving a CR or CRi as best response based on response criteria for iwCLL 2018. |
Up to 5 years
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Duration of response (DoR)
기간: Up to 5 years
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The DoR is defined as the time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018. |
Up to 5 years
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DOSRI- PFS
기간: Until disease progression or death (up to 5 years)
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PFS for Safety Run-in phase is defined as the time from first dose until the date of documented progression or death due to any cause whichever comes first, based on iwCLL 2018 criteria. |
Until disease progression or death (up to 5 years)
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Overall Survival (OS)
기간: Up to 5 years
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OS is defined as the time from first dose until death due to any cause. |
Up to 5 years
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Serum concentrations of Surovatamig
기간: At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)
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To characterise the serum concentration of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV. |
At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)
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Maximum concentration observed (Cmax)
기간: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
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To characterise the pharmacokinetics (PK) of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV. |
At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
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Time to Maximum Concentration (tmax)
기간: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
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To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV. |
At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
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Trough concentration (Ctrough)
기간: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
|
To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV. |
At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
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Number of participants with Anti-drug antibodies (ADA)
기간: At predefined intervals from the date of first dose to approximately 5 years
|
DOSRI- To evaluate the immunogenicity of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV. Phase III- To determine the immunogenicity of SC surovatamig in CLL/SLL participants with uIGHV. |
At predefined intervals from the date of first dose to approximately 5 years
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Phase III- PFS
기간: Until disease progression or death (up to 5 years)
|
PFS is defined as the time from date of randomisation until disease progression or death due to any cause , whichever comes first based on iwCLL 2018 criteria, as assessed by investigator. |
Until disease progression or death (up to 5 years)
|
|
Phase III- Number of participants with AEs and SAEs
기간: Up to 5 years
|
To assess safety and tolerability of SC surovatamig compared to observation in CLL/SLL participants with uIGHV. |
Up to 5 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- D7409C00001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 공유 기간
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 액세스 기준
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
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