Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia (FIRST)
24. oktober 2022 opdateret af: AbbVie
Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Combination With Obinutuzumab in Population of Previously Untreated Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FIRST)
Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Effectiveness is assessed by achievement of best response.
Venetoclax is an approved drug developed for the treatment of CLL. Approximately 50 adult participants with previously untreated CLL will be enrolled in approximately 10 to 15 sites in Russian Federation.
Participants will receive oral venetoclax tablets in combination with intravenous (IV) Obinutuzumab as prescribed by the physician prior to enrolling in this study in accordance to the local practice and label.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
5
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sankt-Peterburg, Den Russiske Føderation, 191024
- Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127
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Tula, Den Russiske Føderation, 300053
- Tula Regional Clinical Hospital /ID# 231128
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Moskva
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Moscow, Moskva, Den Russiske Føderation, 125284
- Moscow State budget healthcare /ID# 226058
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Volgogradskaya Oblast
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Volgograd, Volgogradskaya Oblast, Den Russiske Føderation, 400138
- Regional Children's Clinical Hospital of Volgograd /ID# 238328
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult participants with previously untreated chronic lymphocytic leukemia (CLL)
Beskrivelse
Inclusion Criteria:
- Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL).
- Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.
Exclusion Criteria:
- Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation.
- Creatinine Clearance < 30 milliLitres/minute.
- Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma.
- Participating in a clinical trial with an investigative drug for CLL.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Participants Treated With Venetoclax + Obinutuzumab
Participants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants Achieving Overall Response Rate (ORR) Best Response
Tidsramme: Up to approximately 36 Months
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ORR is defined as complete remission (CR) + complete remission with incomplete bone marrow recovery (CRi) + partial remission (PR) + nodular partial remission (nPR).
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Up to approximately 36 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants Achieving Objective Response Rate (ORR)
Tidsramme: Up to 12 Months
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ORR is defined as CR + CRi + PR + nPR.
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Up to 12 Months
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Time to First Response
Tidsramme: Up to approximately 36 Months
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Time to first response is defined as number of days from first venetoclax intake to first response.
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Up to approximately 36 Months
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Time to Best Response
Tidsramme: Up to approximately 36 Months
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Time to best response is defined as number of days from first venetoclax intake to best response (CR, CRi, PR, nPR).
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Up to approximately 36 Months
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Duration of Response (DoR)
Tidsramme: Up to approximately 36 Months
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Duration of Response (DoR) is defined as number of days from first response to disease progression or death from any cause, whichever comes first.
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Up to approximately 36 Months
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Time to Next Treatment
Tidsramme: Up to approximately 36 Months
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Time to next treatment is defined as number of days from first venetoclax intake to first intake of next treatment including death from any cause.
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Up to approximately 36 Months
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Minimal Residual Disease (MRD)
Tidsramme: Up to 36 Months
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Percentage of participants achieving MRD (CLL < 10000 leucocytes) in the bone marrow, peripheral blood, either and both will be assessed.
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Up to 36 Months
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Overall Survival (OS)
Tidsramme: Up to 36 Months
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OS is defined as the number of days from the date of first dose to the date of the observational period end or death for all dosed participants.
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Up to 36 Months
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Progression-Free Survival (PFS)
Tidsramme: Up to 36 Months
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PFS is defined as the interval (in days) between the first treatment day to the first sign of disease progression or death from any cause.
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Up to 36 Months
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Number of Participants With Adverse Events (AEs)
Tidsramme: Up to approximately 36 Months
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study.
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
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Up to approximately 36 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. december 2020
Primær færdiggørelse (Faktiske)
9. november 2021
Studieafslutning (Faktiske)
9. november 2021
Datoer for studieregistrering
Først indsendt
30. november 2020
Først indsendt, der opfyldte QC-kriterier
30. november 2020
Først opslået (Faktiske)
7. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. oktober 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. oktober 2022
Sidst verificeret
1. oktober 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P20-486
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