NCT03181126 is a Phase 1 clinical trial of Navitoclax in Acute Lymphoblastic Leukemia (ALL), sponsored by AbbVie.

Who is sponsoring NCT03181126?

NCT03181126 is sponsored by AbbVie.

What drugs are being tested in NCT03181126?

Interventions in NCT03181126: Navitoclax, Chemotherapy, Venetoclax.

What condition does NCT03181126 study?

NCT03181126 studies Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma.

Is NCT03181126 still recruiting?

NCT03181126 is currently completed. Last updated 14 October 2021.

Last reviewed 2021-10-14 · How we verify

NCT03181126

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 Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

Completed Phase 1 Last updated 14 October 2021

What this trial tests

Phase 1 trial testing Navitoclax in Acute Lymphoblastic Leukemia (ALL) in 69 participants. Completed in 14 November 2020.

Timeline

27 November 2017

Primary endpoint
11 November 2020

14 November 2020

Quick facts

Lead sponsor	AbbVie
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	69
Start date	27 November 2017
Primary completion	11 November 2020
Estimated completion	14 November 2020
Sites	15 locations across United States, Australia

Drugs / interventions tested

Navitoclax — full drug profile →
Chemotherapy (chemotherapy) — full drug profile →
Venetoclax (venetoclax) — full drug profile →

Conditions studied

Acute Lymphoblastic Leukemia (ALL) — all drugs for Acute Lymphoblastic Leukemia (ALL) →
Lymphoblastic Lymphoma — all drugs for Lymphoblastic Lymphoma →

Sponsor

AbbVie — full company profile →

Who can join

4 and older, any sex, with Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric participants with relapsed/refractory acute lymphoblastic leukemia (ALL) or relapsed/refractory lymphoblastic lymphoma. A safety expansion cohort of approximately 20 patients may be enrolled in addition to the 50 participants in dose-escalation cohort.

Publications & conference data

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

Venetoclax and Navitoclax in Combination with Chemotherapy in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma.
Pullarkat VA, Lacayo NJ, Jabbour E, Rubnitz JE, et al · · 2021 · cited 226× · PMID 33593877 · DOI 10.1158/2159-8290.cd-20-1465
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
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
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
The BCL2 family: from apoptosis mechanisms to new advances in targeted therapy.
Vogler M, Braun Y, Smith VM, Westhoff MA, et al · · 2025 · cited 104× · PMID 40113751 · DOI 10.1038/s41392-025-02176-0
Inhibition of Anti-Apoptotic Bcl-2 Proteins in Preclinical and Clinical Studies: Current Overview in Cancer.
D'Aguanno S, Del Bufalo D. · · 2020 · cited 98× · PMID 32455818 · DOI 10.3390/cells9051287
Found in Translation: How Preclinical Research Is Guiding the Clinical Development of the BCL2-Selective Inhibitor Venetoclax.
Leverson JD, Sampath D, Souers AJ, Rosenberg SH, et al · · 2017 · cited 95× · PMID 29146569 · DOI 10.1158/2159-8290.cd-17-0797
Venetoclax: evidence to date and clinical potential.
Juárez-Salcedo LM, Desai V, Dalia S. · · 2019 · cited 83× · PMID 31645879 · DOI 10.7573/dic.212574

Verify or expand the search:

Other trials of Navitoclax

Trials testing the same drug.

NCT06210750 — Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) · Phase 2 · withdrawn
NCT05740449 — HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Mal · Phase 1, PHASE2 · withdrawn
NCT05864742 — Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma · Phase 2 · active not recruiting
NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome · Phase 1 · active not recruiting
NCT05358639 — Combination of Olaparib and Navitoclax in Women with HGSC and TNBC · Phase 1 · active not recruiting

Other recruiting trials for Acute Lymphoblastic Leukemia (ALL)

Currently open trials in the same condition.

NCT07246213 — CAYA Cancer Retrospective Cohort Study · recruiting
NCT05884333 — Cord Blood Transplant in Adults With Blood Cancers · Phase 2 · recruiting
NCT03849651 — TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-ce · Phase 2 · active not recruiting
NCT03590171 — International Study for Treatment of High Risk Childhood Relapsed ALL 2010 · Phase 2 · recruiting
NCT02790515 — Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical · Phase 2 · active not recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · 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 NCT03181126 (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 AbbVie
Last refreshed: 14 October 2021

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/NCT03181126.

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