NCT03128879 is a Phase 2 clinical trial of Ibrutinib in Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.

Who is sponsoring NCT03128879?

NCT03128879 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT03128879?

Interventions in NCT03128879: Ibrutinib, Venetoclax, Acalabrutinib.

What condition does NCT03128879 study?

NCT03128879 studies Chronic Lymphocytic Leukemia.

Is NCT03128879 still recruiting?

NCT03128879 is currently recruiting now. Last updated 21 November 2025.

Last reviewed 2025-11-21 · How we verify

NCT03128879

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

Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL

Recruiting now Phase 2 Last updated 21 November 2025

What this trial tests

Phase 2 trial testing Ibrutinib in Chronic Lymphocytic Leukemia in 90 participants. Currently enrolling.

Timeline

16 June 2017

Primary endpoint
31 May 2027

31 May 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	16 June 2017
Primary completion	31 May 2027
Estimated completion	31 May 2027
Sites	1 location across United States

Drugs / interventions tested

Ibrutinib (ibrutinib) — full drug profile →
Venetoclax (venetoclax) — full drug profile →
Acalabrutinib (ACALABRUTINIB) — full drug profile →

Conditions studied

Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

M.D. Anderson Cancer Center — 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 is a single center, open-label, phase II study of venetoclax (ABT-199) added to ibrutinib or acalabrutinib in patients with high-risk CLL who have received at least 12 months of ibrutinib or acalabrutinib monotherapy. The study will estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable CLL after receiving ibrutinib or acalabrutinib for at least 12 months and who have high risk CLL.

Publications & conference data

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

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
Unlocking the NF-κB Conundrum: Embracing Complexity to Achieve Specificity.
Begalli F, Bennett J, Capece D, Verzella D, et al · · 2017 · cited 51× · PMID 28829404 · DOI 10.3390/biomedicines5030050
From Biology to Therapy: The CLL Success Story.
Yosifov DY, Wolf C, Stilgenbauer S, Mertens D. · · 2019 · cited 48× · PMID 31723816 · DOI 10.1097/hs9.0000000000000175
Overcoming resistance to targeted therapies in chronic lymphocytic leukemia.
Skånland SS, Mato AR. · · 2021 · cited 42× · PMID 33570649 · DOI 10.1182/bloodadvances.2020003423
The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
Revolution of Chronic Lymphocytic Leukemia Therapy: the Chemo-Free Treatment Paradigm.
Scheffold A, Stilgenbauer S. · · 2020 · cited 20× · PMID 32025827 · DOI 10.1007/s11912-020-0881-4
Combining BTK inhibitors with BCL2 inhibitors for treating chronic lymphocytic leukemia and mantle cell lymphoma.
Zhang J, Lu X, Li J, Miao Y. · · 2022 · cited 19× · PMID 35379357 · DOI 10.1186/s40364-022-00357-5
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 Ibrutinib

Trials testing the same drug.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07052695 — Mosunetuzumab for CLL MRD Clearance · Phase 1, PHASE2 · recruiting
NCT06649812 — Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggress · Phase 2 · recruiting
NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia · Phase 1 · not yet recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · 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 M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
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
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet 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 NCT03128879 (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 M.D. Anderson Cancer Center
Last refreshed: 21 November 2025

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/NCT03128879.

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