Surovatamig som konsolideringsterapi hos deltagare med kronisk lymfatisk leukemi eller småcelligt lymfocytärt lymfom med omuterad immunoglobulintung kedjevariabel (IGHV) (SOUNDTRACK-C1)
En fas III, randomiserad, öppen, multimetrisk studie av Surovatamig som konsolideringsterapi jämfört med observation efter första linjens induktionsterapi hos deltagare med kronisk lymfatisk leukemi eller småcellig lymfocytlymfom med omuterad IGHV (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).
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studieorter
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Adelaide, Australien, 5000
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Fitzroy, Australien, 3065
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Heidelberg, Australien, 3084
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Nedlands, Australien, 6009
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Perth, Australien, 6847
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Rockingham, Australien, 6168
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California
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La Jolla, California, Förenta staterna, 92093
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Colorado
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Denver, Colorado, Förenta staterna, 80218
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06510
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Illinois
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Chicago, Illinois, Förenta staterna, 60637
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Kansas
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Kansas City, Kansas, Förenta staterna, 66210
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40207
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Maryland
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Bethesda, Maryland, Förenta staterna, 20817
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
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New Jersey
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Basking Ridge, New Jersey, Förenta staterna, 07920
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New York
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Rochester, New York, Förenta staterna, 14642
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15232
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Texas
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Houston, Texas, Förenta staterna, 77030
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 4E6
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2Y9
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Ontario
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Hamilton, Ontario, Kanada, L8V 5C2
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Toronto, Ontario, Kanada, M5G 2L7
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Quebec
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Montreal, Quebec, Kanada, H3T 1E2
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Montreal, Quebec, Kanada, H2L 4M1
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Québec, Quebec, Kanada, G1J 1Z4
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Edinburgh, Storbritannien, EH4 2XU
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Hampshire, Storbritannien, SO16 6YD
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Leeds, Storbritannien, LS9 7TF
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London, Storbritannien, SE5 9RS
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London, Storbritannien, NW1 2BU
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Manchester, Storbritannien, M20 4BX
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Nottingham, Storbritannien, NG5 1PB
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Oxford, Storbritannien, OX3 7LE
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Sutton, Storbritannien, SM2 5PT
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Adapazarı, Turkiet (Türkiye), 54100
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Antalya, Turkiet (Türkiye), 07025
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Istanbul, Turkiet (Türkiye), 34098
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Istanbul, Turkiet (Türkiye), 34899
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Istanbul, Turkiet (Türkiye), 34517
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Kocaeli, Turkiet (Türkiye), 41380
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Mezitli, Turkiet (Türkiye), 33200
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
Andra namn:
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Experimentell: 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.
Andra namn:
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Experimentell: 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.
Andra namn:
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Inget ingripande: Phase III-Arm B: Observation
Participants will undergo observation for 24 weeks. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Up to 5 years
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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)
Tidsram: 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
Tidsram: Up to 5 years
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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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Objective Response Rate (ORR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Number of participants with Anti-drug antibodies (ADA)
Tidsram: At predefined intervals from the date of first dose to approximately 5 years
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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
Tidsram: 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 comes first based on iwCLL 2018 criteria, as assessed by investigator. |
Until disease progression or death (up to 5 years)
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Phase III- Number of participants with AEs and SAEs
Tidsram: Up to 5 years
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To assess safety and tolerability of SC surovatamig compared to observation in CLL/SLL participants with uIGHV. |
Up to 5 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D7409C00001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
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