JOURNAL ONKOLOGIE – STUDIE

ReVenG

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04895436

Studienbeginn:
März 2022

Letztes Update:
18.04.2024

Wirkstoff:
Venetoclax, Obinutuzumab

Indikation (Clinical Trials):
Leukemia, Leukemia, Lymphoid, Leukemia, Lymphocytic, Chronic, B-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
AbbVie

Collaborator:
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

ABBVIE CALL CENTER
Kontakt:
Phone: 844-663-3742
E-Mail: abbvieclinicaltrials@abbvie.com» Kontaktdaten anzeigen

Studienlocations
(3 von 48)

Stauferklinikum Schwaebisch Gmuend /ID# 230176
73557 Mutlangen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Ulm /ID# 230164
89081 Ulm
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps

VK&K Studien GbR /ID# 230198
84036 Landshut
(Bayern)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Koeln /ID# 230296
50937 Köln
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps

Gemeinschaftspraxis Haematologie - Onkologie BAG /ID# 230168
01307 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
24105 Kiel
(Schleswig-Holstein)
GermanyAktiv, nicht rekrutierend» Google-Maps

Onkologische Schwerpunktpraxis /ID# 245465
10707 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps

Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 248748
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps

DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
28239 Bremen
(Bremen)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Essen /ID# 230181
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Halle (Saale) /ID# 245350
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps

OncoResearch Lerchenfeld GmbH /ID# 230191
22081 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum des Saarlandes /ID# 248747
66424 Homburg
(Saarland)
GermanyRekrutierend» Google-Maps

Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
84034 Landshut
(Bayern)
GermanyRekrutierend» Google-Maps

Muenchen Klinik Schwabing /ID# 230197
80804 Muenchen
(Bayern)
GermanyAbgeschlossen» Google-Maps

Bruederkrankenhaus St. Josef Paderborn /ID# 230177
33098 Paderborn
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps

Universitaetsmedizin Rostock /ID# 230190
18057 Rostock
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps

Moores Cancer Center at UC San Diego /ID# 230157
92093 La Jolla
United StatesAktiv, nicht rekrutierend» Google-Maps

Des Moines Oncology Research Association /ID# 232606
50309-1423 Des Moines
United StatesRekrutierend» Google-Maps

Dana-Farber Cancer Institute /ID# 230061
02215 Boston
United StatesRekrutierend» Google-Maps

Henry Ford Health System /ID# 230268
48202 Detroit
United StatesRekrutierend» Google-Maps

St. Luke's Hospital of Duluth /ID# 250021
55805 Duluth
United StatesRekrutierend» Google-Maps

Summit Medical Group-Florham Park /ID# 244782
07932-1049 Florham Park
United StatesRekrutierend» Google-Maps

Regional Cancer Care Associates /ID# 244620
07601-7015 Hackensack
United StatesRekrutierend» Google-Maps

Novant Health Presbyterian Medical Center /ID# 230201
28204 Charlotte
United StatesRekrutierend» Google-Maps

Novant Health Forsyth Medical Center /ID# 249533
27103 Winston-Salem
United StatesRekrutierend» Google-Maps

University of Wisconsin-Madiso /ID# 232612
53705 Madison
United StatesRekrutierend» Google-Maps

Royal Adelaide Hospital /ID# 229898
5000 Adelaide
AustraliaRekrutierend» Google-Maps

Northern Hospital Epping /ID# 229847
3076 Epping
AustraliaAktiv, nicht rekrutierend» Google-Maps

Peter MacCallum Cancer Ctr /ID# 254634
3000 Melbourne
AustraliaRekrutierend» Google-Maps

Universitaetsklinikum St. Poelten /ID# 243493
3100 Sankt Poelten
AustriaRekrutierend» Google-Maps

Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
4010 Linz
AustriaRekrutierend» Google-Maps

Medizinische Universitaet Wien /ID# 230013
1090 Vienna
AustriaRekrutierend» Google-Maps

Klinik Ottakring /ID# 230019
1160 Vienna
AustriaAktiv, nicht rekrutierend» Google-Maps

Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
5020 Salzburg
AustriaRekrutierend» Google-Maps

Hanusch Krankenhaus /ID# 230010
1140 Wien
AustriaRekrutierend» Google-Maps

Hospital de Clinicas de Porto Alegre /ID# 243657
90035-903 Porto Alegre
BrazilRekrutierend» Google-Maps

Hospital Nove de Julho /ID# 243658
01409-001 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps

Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
01236-030 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps

MHAT Hristo Botev /ID# 229687
3000 Vratsa
BulgariaRekrutierend» Google-Maps

Rabin Medical Center /ID# 243220
4941492 Haifa
IsraelRekrutierend» Google-Maps

The Chaim Sheba Medical Center /ID# 243219
5265601 Ramat Gan
IsraelRekrutierend» Google-Maps

Tel Aviv Sourasky Medical Center /ID# 243218
6423906 Tel Aviv
IsraelAktiv, nicht rekrutierend» Google-Maps

Hadassah /ID# 245059
91120 Jerusalem
IsraelRekrutierend» Google-Maps

AOU Citta della Salute e della Scienza di Torino /ID# 229504
10126 Torino
ItalyRekrutierend» Google-Maps

Azienda Ospedaliera Santa Maria Terni /ID# 229442
05100 Terni
ItalyRekrutierend» Google-Maps

Institutul Clinic Fundeni /ID# 241614
022328 Bucharest
RomaniaRekrutierend» Google-Maps

Hospital Universitario de la Princesa /ID# 229665
28006 Madrid
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The

purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in

participants previously treated with fixed duration first-line (IL) therapy of venetoclax in

combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events

and change in disease activity will be assessed.

Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants

in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous

treatment in first-line. Approximately 75 adult participants with CLL who have been treated

with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study

in approximately 60 sites worldwide.

Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day

cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone,

for a total treatment of 12 to 24 cycles, depending on the cohort.

There may be higher treatment burden for participants in this trial compared to their

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for

CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018

criteria.

- Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration

first-line (1L) therapy and achieved documented response, defined as complete

remission, complete remission with incomplete marrow recovery, partial remission, or

nodular partial remission.

- More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last

dose of venetoclax and disease progression after completion of 1L treatment.

Exclusion Criteria:

- Received intervening treatment for CLL after completing previous treatment with a

venetoclax + anti-CD20 antibody +/- X regimen.

Studien-Rationale

Primary outcome:

1. Overall response (OR) in Cohort 1 after end of combination treatment (Time Frame - 9 months):
OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.

Secondary outcome:

1. OR in Cohort 1 after end of combination treatment (Time Frame - 9 months):
OR rate is defined as the percentage of participants achieving a best response of CR or CRi

2. OR in Cohort 1 after end of treatment (Time Frame - 15 months):
OR is defined as the percentage of participants achieving a best response of PR, nPR, CRi, or CR. Disease assessments will be based on the 2018 iwCLL criteria for tumor response.

3. Time to Response (TTR) in Cohort 1 (Time Frame - 15 months):
TTR is defined as the time from first dose until first response (PR or better).

4. Duration of Response (DOR) in Cohort 1 (Time Frame - 15 months):
DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.

5. Time to Next Treatment (TTNT) for CLL in Cohort 1 (Time Frame - 15 months):
TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.

6. Progression-free Survival (PFS) in Cohort 1 (Time Frame - 15 months):
PFS is defined as the time from first dose until PD or death.

7. Overall Survival (OS) in Cohort 1 (Time Frame - 15 months):
OS is defined as the time from first dose until death.

8. Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment (Time Frame - 9 months):
Percentage of participants with uMRD rate, measured in peripheral blood.

9. Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment (Time Frame - 15 months):
Percentage of participants with uMRD rate, measured in peripheral blood.

Studien-Arme

Experimental: Cohort 1 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Experimental: Cohort 2 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.

Geprüfte Regime

Venetoclax (Venclexta / ABT-199 / GDC-0199 / ):
Oral tablet
Obinutuzumab (GA101 / Gazyva / ):
Intravenous (IV) infusion

Quelle: ClinicalTrials.gov

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