GAIA

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Official title

A Phase 3 Multicenter, Randomized, Prospective, Open-label Trial of Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab Plus Venetoclax (RVe) Versus Obinutuzumab (GA101) Plus Venetoclax (GVe) Versus Obinutuzumab Plus Ibrutinib Plus Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation

Phase

Phase 3

Status

Completed

Conditions

Chronic Lymphocytic Leukemia

Interventions

Fludarabine; Cyclophosphamide; Rituximab; Bendamustine; Venetoclax; Obinutuzumab; Ibrutinib

Arms

• Standard chemoimmunotherapy (SCIT) · Active comparator
• Rituximab + Venetoclax (RVe) · Experimental
• Obinutuzumab + Venetoclax (GVe) · Experimental
• Obinutuzumab + Ibrutinib + Venetoclax (GIVe) · Experimental

Enrollment

926

Primary outcomes

• Miminimal residual disease (MRD) negativity rate in peripheral blood (PB)
• Progression free survival (PFS)

Sponsor

German CLL Study Group with Janssen-Cilag Ltd., Hoffmann-La Roche, AbbVie, Stichting Hemato-Oncologie voor Volwassenen Nederland, Nordic CLL Study Group (NCLLSG), Swiss Cancer Institute, Cancer Trials Ireland, Israeli CLL Study Group

Start

Dec 13, 2016

Primary completion

Feb 29, 2024

Results posted

No

Registry record

NCT02950051 · updated Dec 30, 2024

• Furstenau M, Kater AP, Robrecht S, von Tresckow J, Zhang C, Gregor M, Thornton P, Staber PB, Tadmor T, Lindstrom V, Juliusson G, Janssens A, Levin MD, da Cunha-Bang C, Schneider C, Goldschmidt N, Vandenberghe E, Rossi D, Benz R, Nosslinger T, Heintel D, Poulsen CB, Christiansen I, Frederiksen H, Enggaard L, Posthuma EFM, Issa DE, Visser HPJ, Bellido M, Kutsch N, Durig J, Stehle A, Vohringer M, Bottcher S, Schulte C, Simon F, Fink AM, Fischer K, Holmes EE, Kreuzer KA, Ritgen M, Bruggemann M, Tausch E, Stilgenbauer S, Hallek M, Niemann CU, Eichhorst B. First-line venetoclax combinations versus chemoimmunotherapy in fit patients with chronic lymphocytic leukaemia (GAIA/CLL13): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2024 Jun;25(6):744-759. doi: 10.1016/S1470-2045(24)00196-7. PubMed 38821083
• Eichhorst B, Niemann CU, Kater AP, Furstenau M, von Tresckow J, Zhang C, Robrecht S, Gregor M, Juliusson G, Thornton P, Staber PB, Tadmor T, Lindstrom V, da Cunha-Bang C, Schneider C, Poulsen CB, Illmer T, Schottker B, Nosslinger T, Janssens A, Christiansen I, Baumann M, Frederiksen H, van der Klift M, Jager U, Leys MBL, Hoogendoorn M, Lotfi K, Hebart H, Gaska T, Koene H, Enggaard L, Goede J, Regelink JC, Widmer A, Simon F, De Silva N, Fink AM, Bahlo J, Fischer K, Wendtner CM, Kreuzer KA, Ritgen M, Bruggemann M, Tausch E, Levin MD, van Oers M, Geisler C, Stilgenbauer S, Hallek M; GCLLSG, the HOVON and Nordic CLL Study Groups, the SAKK, the Israeli CLL Association, and Cancer Trials Ireland. First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia. N Engl J Med. 2023 May 11;388(19):1739-1754. doi: 10.1056/NEJMoa2213093. PubMed 37163621
• Jebaraj BMC, Tausch E, Yosifov DY, Schneider C, Furstenau M, Zhang C, Robrecht S, da Cunha-Bang C, Levin MD, Staber PB, Huber H, Tadmor T, Thornton P, Gregor M, Fink AM, Fischer K, Kreuzer KA, Ritgen M, Hallek MJ, Kater AP, Niemann CU, Eichhorst BF, Stilgenbauer S. Telomere length in chronic lymphocytic leukemia treated with venetoclax-based regimen in GAIA/CLL13 and CLL2-GIVe trials. Blood. 2026 Oct 6:blood.2025032302. doi: 10.1182/blood.2025032302. Online ahead of print. PubMed 42837320
• Furstenau M, Niemann CU, Robrecht S, Rotbain EC, Eurelings L, Giza A, von Tresckow J, Zhang C, Gregor M, Thornton P, Staber PB, Tadmor T, Lindstrom V, Juliusson G, Janssens A, da Cunha-Bang C, Schneider C, Herishanu Y, O'Shea D, Baumann M, Widmer A, Nosslinger T, Poulsen CB, Frederiksen H, Lotfi K, Ranti J, Enggaard L, Velders G, Vekemans MC, de Heer K, Snijders TF, Siemes C, Wendtner CM, Knauf W, Kroeber A, Zahn MO, Illmer T, Schottker B, Simon F, Fink A, Fischer K, D'Brot R, Holmes E, Kreuzer KA, Ritgen M, Bruggemann M, Tausch E, Stilgenbauer S, Levin MD, Hallek M, Kater AP, Eichhorst B. Venetoclax combinations in untreated CLL: 5-year results and patient-reported outcomes analysis of the CLL13/GAIA trial. Blood. 2026 Jun 18;147(25):3025-3038. doi: 10.1182/blood.2025032160. PubMed 41911073
• Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564. PubMed 38620092
• Furstenau M, Thus YJ, Robrecht S, Mellink CHM, van der Kevie-Kersemaekers AM, Dubois J, von Tresckow J, Patz M, Gregor M, Thornton P, Staber PB, Tadmor T, Levin MD, da Cunha-Bang C, Schneider C, Poulsen CB, Illmer T, Schottker B, Janssens A, Christiansen I, Nosslinger T, Baumann M, Hebart H, Gaska T, Regelink JC, Dompeling EC, Lindstrom V, Juliusson G, Widmer A, Goede J, Goldschmidt N, Simon F, De Silva N, Fink AM, Fischer K, Wendtner CM, Ritgen M, Bruggemann M, Tausch E, Spaargaren M, Eldering E, Stilgenbauer S, Niemann CU, Hallek M, Eichhorst B, Kreuzer KA, Kater AP. High karyotypic complexity is an independent prognostic factor in patients with CLL treated with venetoclax combinations. Blood. 2023 Aug 3;142(5):446-459. doi: 10.1182/blood.2023019634. PubMed 37172204
• Furstenau M, Langerbeins P, De Silva N, Fink AM, Robrecht S, von Tresckow J, Simon F, Hohloch K, Droogendijk J, van der Klift M, van der Spek E, Illmer T, Schottker B, Fischer K, Wendtner CM, Tausch E, Stilgenbauer S, Niemann CU, Gregor M, Kater AP, Hallek M, Eichhorst B. COVID-19 among fit patients with CLL treated with venetoclax-based combinations. Leukemia. 2020 Aug;34(8):2225-2229. doi: 10.1038/s41375-020-0941-7. Epub 2020 Jun 29. No abstract available. PubMed 32601378