NCT01671904 is a Phase 1 clinical trial of Bendamustine in Chronic Lymphocytic Leukemia, sponsored by Genentech, Inc..

Who is sponsoring NCT01671904?

NCT01671904 is sponsored by Genentech, Inc..

What drugs are being tested in NCT01671904?

Interventions in NCT01671904: Bendamustine, Obinutuzumab, Rituximab, Venetoclax.

What condition does NCT01671904 study?

NCT01671904 studies Chronic Lymphocytic Leukemia.

Is NCT01671904 still recruiting?

NCT01671904 is currently completed. Last updated 14 October 2020.

Last reviewed 2020-10-14 · How we verify

NCT01671904

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

A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Completed Phase 1 Last updated 14 October 2020

What this trial tests

Phase 1 trial testing Bendamustine in Chronic Lymphocytic Leukemia in 84 participants. Completed in 11 August 2020.

Timeline

13 January 2014

Primary endpoint
17 August 2018

11 August 2020

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	13 January 2014
Primary completion	17 August 2018
Estimated completion	11 August 2020
Sites	12 locations across France, United States, Germany

Drugs / interventions tested

Bendamustine (BENDAMUSTINE) — full drug profile →
Obinutuzumab — full drug profile →
Rituximab — full drug profile →
Venetoclax (venetoclax) — full drug profile →

Conditions studied

Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

Genentech, Inc. — 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

This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V.

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
ABT-199 (venetoclax) and BCL-2 inhibitors in clinical development.
Cang S, Iragavarapu C, Savooji J, Song Y, et al · · 2015 · cited 216× · PMID 26589495 · DOI 10.1186/s13045-015-0224-3
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 the Bcl-2 Family in B Cell Lymphoma.
Adams CM, Clark-Garvey S, Porcu P, Eischen CM. · · 2018 · cited 112× · PMID 30671383 · DOI 10.3389/fonc.2018.00636
Synergistic induction of apoptosis in high-risk DLBCL by BCL2 inhibition with ABT-199 combined with pharmacologic loss of MCL1.
Li L, Pongtornpipat P, Tiutan T, Kendrick SL, et al · · 2015 · cited 83× · PMID 25882699 · DOI 10.1038/leu.2015.99
The Development and Current Use of BCL-2 Inhibitors for the Treatment of Chronic Lymphocytic Leukemia.
Lampson BL, Davids MS. · · 2017 · cited 38× · PMID 28116634 · DOI 10.1007/s11899-017-0359-0
Development of venetoclax for therapy of lymphoid malignancies.
Zhu H, Almasan A. · · 2017 · cited 21× · PMID 28331288 · DOI 10.2147/dddt.s109325
A review of the incidence of tumor lysis syndrome in patients with chronic lymphocytic leukemia treated with venetoclax and debulking strategies.
Sharman JP, Biondo JML, Boyer M, Fischer K, et al · · 2022 · cited 15× · PMID 35846043 · DOI 10.1002/jha2.427

Verify or expand the search:

Other trials of Bendamustine

Trials testing the same drug.

NCT07225985 — Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Re · Phase 1, PHASE2 · not yet recruiting
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 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 Genentech, Inc. trials

Trials by the same sponsor.

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NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas · Phase 2 · recruiting
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting

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 NCT01671904 (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 Genentech, Inc.
Last refreshed: 14 October 2020

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/NCT01671904.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing