NCT02950051 (GAIA) is a Phase 3 clinical trial of Fludarabine in Chronic Lymphocytic Leukemia, sponsored by German CLL Study Group.

Who is sponsoring NCT02950051?

NCT02950051 is sponsored by German CLL Study Group.

What drugs are being tested in NCT02950051?

Interventions in NCT02950051: Fludarabine, Cyclophosphamide, Rituximab, Bendamustine, Venetoclax, Obinutuzumab, Ibrutinib.

What condition does NCT02950051 study?

NCT02950051 studies Chronic Lymphocytic Leukemia.

Is NCT02950051 still recruiting?

NCT02950051 is currently completed. Last updated 30 December 2024.

Last reviewed 2024-12-30 · How we verify

NCT02950051: GAIA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation

Completed Phase 3 Last updated 30 December 2024

What this trial tests

Phase 3 trial testing Fludarabine in Chronic Lymphocytic Leukemia in 926 participants. Completed in 29 February 2024.

Timeline

13 December 2016

Primary endpoint
29 February 2024

29 February 2024

Quick facts

Lead sponsor	German CLL Study Group
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	926
Start date	13 December 2016
Primary completion	29 February 2024
Estimated completion	29 February 2024
Sites	161 locations across Denmark, Finland, Netherlands, Belgium, Austria, Sweden, Ireland, Germany

Drugs / interventions tested

Fludarabine (FLUDARABINE) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Rituximab
Bendamustine (BENDAMUSTINE) — full drug profile →
Venetoclax
Obinutuzumab — full drug profile →
Ibrutinib (ibrutinib) — full drug profile →

Conditions studied

Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

German CLL Study Group — full company profile →

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Pathways and mechanisms of venetoclax resistance.
Bose P, Gandhi V, Konopleva M. · · 2017 · cited 223× · PMID 28140720 · DOI 10.1080/10428194.2017.1283032
First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia.
Eichhorst B, Niemann CU, Kater AP, Fürstenau M, et al · · 2023 · cited 209× · PMID 37163621 · DOI 10.1056/nejmoa2213093
BCL-2 as therapeutic target for hematological malignancies.
Perini GF, Ribeiro GN, Pinto Neto JV, Campos LT, et al · · 2018 · cited 153× · PMID 29747654 · DOI 10.1186/s13045-018-0608-2
Targeting Bruton's Tyrosine Kinase in CLL.
Ahn IE, Brown JR. · · 2021 · cited 62× · PMID 34248972 · DOI 10.3389/fimmu.2021.687458
Current and future treatment strategies in chronic lymphocytic leukemia.
Patel K, Pagel JM. · · 2021 · cited 60× · PMID 33902665 · DOI 10.1186/s13045-021-01054-w
Phase 1b study of venetoclax-obinutuzumab in previously untreated and relapsed/refractory chronic lymphocytic leukemia.
Flinn IW, Gribben JG, Dyer MJS, Wierda W, et al · · 2019 · cited 53× · PMID 30862645 · DOI 10.1182/blood-2019-01-896290
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.
Fürstenau M, Kater AP, Robrecht S, von Tresckow J, et al · · 2024 · cited 52× · PMID 38821083 · DOI 10.1016/s1470-2045(24)00196-7
Chronic lymphocytic leukemia treatment algorithm 2022.
Hampel PJ, Parikh SA. · · 2022 · cited 51× · PMID 36446777 · DOI 10.1038/s41408-022-00756-9

Verify or expand the search:

Other trials of Fludarabine

Trials testing the same drug.

NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
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NCT07411599 — Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Chronic Lymphocytic Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype · Phase 2 · recruiting
NCT07218510 — Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Smal · Phase 2 · recruiting
NCT07288515 — Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus · recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting

Other German CLL Study Group trials

Trials by the same sponsor.

NCT06792994 — A Prospective Observational Trial to Assess Treatment Sequences and Factors That Impact Overall Sur-vival in Patients Wi · not yet recruiting
NCT04883749 — Efficacy of Acalabrutinib in Very Old or Frail Patients With Treatment-naïve or Relapsed/Refractory CLL · Phase 2 · completed
NCT03787264 — Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Rela · Phase 2 · completed
NCT03153514 — Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter's Transformation Requiring Allog · Phase 2 · terminated
NCT02689141 — Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02950051 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by German CLL Study Group
Last refreshed: 30 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02950051.

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