Surovatamig als Konsolidierungstherapie bei Teilnehmern mit chronischer lymphatischer Leukämie oder kleinzelligem lymphozytischem Lymphom mit nicht-mutierter Immunglobulin-Schwerketten-Variabler (IGHV) (SOUNDTRACK-C1)
Eine Phase-III-, randomisierte, offene, multizentrische Studie zu Surovatamig als Konsolidierungstherapie versus Beobachtung nach Erstlinien-Induktionstherapie bei Teilnehmern mit chronischer lymphatischer Leukämie oder kleinzelligem lymphatischem Lymphom mit unmutiertem 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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-Mail: information.center@astrazeneca.com
Studienorte
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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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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
- Suspendiert
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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
- Suspendiert
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Québec, Quebec, Kanada, G1J 1Z4
- Suspendiert
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Adapazarı, Türkei (türkiye), 54100
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Antalya, Türkei (türkiye), 07025
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Istanbul, Türkei (türkiye), 34098
- Noch keine Rekrutierung
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Istanbul, Türkei (türkiye), 34899
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Istanbul, Türkei (türkiye), 34517
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Kocaeli, Türkei (türkiye), 41380
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Mezitli, Türkei (türkiye), 33200
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California
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La Jolla, California, Vereinigte Staaten, 92093
- Noch keine Rekrutierung
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80218
- Noch keine Rekrutierung
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06510
- Noch keine Rekrutierung
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60637
- Noch keine Rekrutierung
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66210
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Kentucky
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Louisville, Kentucky, Vereinigte Staaten, 40207
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20817
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
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Minnesota
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Rochester, Minnesota, Vereinigte Staaten, 55905
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New Jersey
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Basking Ridge, New Jersey, Vereinigte Staaten, 07920
- Noch keine Rekrutierung
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New York
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Rochester, New York, Vereinigte Staaten, 14642
- Noch keine Rekrutierung
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
- Noch keine Rekrutierung
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
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Edinburgh, Vereinigtes Königreich, EH4 2XU
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Hampshire, Vereinigtes Königreich, SO16 6YD
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Leeds, Vereinigtes Königreich, LS9 7TF
- Noch keine Rekrutierung
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London, Vereinigtes Königreich, SE5 9RS
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London, Vereinigtes Königreich, NW1 2BU
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Manchester, Vereinigtes Königreich, M20 4BX
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Nottingham, Vereinigtes Königreich, NG5 1PB
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Oxford, Vereinigtes Königreich, OX3 7LE
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Sutton, Vereinigtes Königreich, SM2 5PT
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
Andere Namen:
|
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Experimental: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Kein Eingriff: Phase III-Arm B: Observation
Participants will undergo observation for 24 weeks. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Objective Response Rate (ORR)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Until disease progression or death (up to 5 years)
|
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)
Zeitfenster: 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
Zeitfenster: At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)
|
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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
|
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Phase III- Number of participants with AEs and SAEs
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- D7409C00001
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