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NCT02345863
Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients
Completed
Phase 2
Last updated 8 May 2019
What this trial tests
Phase 2 trial testing Bendamustine in Chronic Lymphocytic Leucemia in 66 participants. Completed in 29 March 2019.
Timeline
16 January 2015
Primary endpoint
22 August 2016
22 August 2016
29 March 2019
Quick facts
| Lead sponsor | German CLL Study Group |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 16 January 2015 |
| Primary completion | 22 August 2016 |
| Estimated completion | 29 March 2019 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Bendamustine (BENDAMUSTINE) — full drug profile →
- GA101 — full drug profile →
- Ibrutinib (ibrutinib) — full drug profile →
Conditions studied
- Chronic Lymphocytic Leucemia — all drugs for Chronic Lymphocytic Leucemia →
Sponsor
German CLL Study Group — full company profile →
Who can join
18 and older, any sex, with Chronic Lymphocytic Leucemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib and GA101 maintenance in CLL patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Anti-CD20 monoclonal antibodies: reviewing a revolution.
Casan JML, Wong J, Northcott MJ, Opat S. · · 2018 · cited 86× · PMID 30096012 · DOI 10.1080/21645515.2018.1508624 -
Obinutuzumab in the treatment of B-cell malignancies: a comprehensive review.
Davies A, Kater AP, Sharman JP, Stilgenbauer S, et al · · 2022 · cited 23× · PMID 35856239 · DOI 10.2217/fon-2022-0112 -
CLL2-BXX Phase II trials: sequential, targeted treatment for eradication of minimal residual disease in chronic lymphocytic leukemia.
Cramer P, von Tresckow J, Bahlo J, Engelke A, et al · · 2018 · cited 23× · PMID 29465308 · DOI 10.2217/fon-2017-0442 -
Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies.
Langerbeins P, Giza A, Robrecht S, Cramer P, et al · · 2024 · cited 19× · PMID 38620092 · DOI 10.1182/blood.2023022564 -
Bendamustine, followed by ofatumumab and ibrutinib in chronic lymphocytic leukemia (CLL2-BIO): primary endpoint analysis of a multicenter, open-label phase-II trial.
Cramer P, Tresckow JV, Robrecht S, Bahlo J, et al · · 2021 · cited 14× · PMID 32107341 · DOI 10.3324/haematol.2019.223693 -
Clinical application of obinutuzumab for treating chronic lymphocytic leukemia.
Luan C, Chen B. · · 2019 · cited 13× · PMID 31692500 · DOI 10.2147/dddt.s212500 -
Obinutuzumab in chronic lymphocytic leukemia: design, development and place in therapy.
Al-Sawaf O, Fischer K, Engelke A, Pflug N, et al · · 2017 · cited 13× · PMID 28182141 · DOI 10.2147/dddt.s104869 -
Durable remissions following combined targeted therapy in patients with CLL harboring TP53 deletions and/or mutations.
Cramer P, Tausch E, von Tresckow J, Giza A, et al · · 2021 · cited 10× · PMID 34086865 · DOI 10.1182/blood.2020010484
Verify or expand the search:
- PubMed search for NCT02345863
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT07189065 — A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma · Phase 2 · recruiting
- NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia · Phase 1 · not yet recruiting
- NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
- NCT07003464 — Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: · Phase 2 · not yet 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
- NCT02950051 — Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) · Phase 3 · 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 NCT02345863 (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: 8 May 2019
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/NCT02345863.
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