NCT05054465 (ITALLI001) is a Phase 1, PHASE2 clinical trial of Navitoclax in Acute Lymphoblastic Leukemia, sponsored by Israeli Medical Association.

Who is sponsoring NCT05054465?

NCT05054465 is sponsored by Israeli Medical Association.

What drugs are being tested in NCT05054465?

Interventions in NCT05054465: Navitoclax, Venetoclax.

What condition does NCT05054465 study?

NCT05054465 studies Acute Lymphoblastic Leukemia.

Is NCT05054465 still recruiting?

NCT05054465 is currently not yet recruiting. Last updated 23 September 2021.

Last reviewed 2021-09-23 · How we verify

NCT05054465: ITALLI001

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

A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL

Not yet recruiting Phase 1, PHASE2 Last updated 23 September 2021

What this trial tests

Phase 1, PHASE2 trial testing Navitoclax in Acute Lymphoblastic Leukemia in 48 participants. Not yet recruiting.

Timeline

1 October 2021

Primary endpoint
1 August 2025

1 August 2026

Quick facts

Lead sponsor	Israeli Medical Association
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 October 2021
Primary completion	1 August 2025
Estimated completion	1 August 2026
Sites	6 locations across Israel

Drugs / interventions tested

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

Conditions studied

Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →

Sponsor

Israeli Medical Association

Who can join

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

Sponsor's own description

This is a national, multicenter, phase II clinical trial to evaluate the potential benefit of pre-transplant consolidation and post-transplant maintenance with navitoclax and venetoclax in patients with T-ALL, LBL and MPAL T/M in first complete remission designated for allogeneic transplantation. Pre-transplantation consolidation with venetoclax and navitoclax: Patients in CR designated for transplantation will be treated with venetoclax 400 mg QD and navitoclax 50mg QD according to the RP2D presented by Pullarkat et al. (Cancer Discov . 2021 Feb 16;candisc.1465.2020. doi: 10.1158/2159-8290.CD-20-1465.) for two 28 day cycles. Following 2 cycles re-staging marrow including MRD assessment and imaging as need will be followed by alloSCT according to local protocol. Post-transplantation maintenance with venetoclax and navitoclax: Within 90 days from alloSCT patients will be started on venetoclax and navitoclax maintenance. Due to lack of data regarding the toxicity of navitoclax and venetoclax in the ALL post alloSCT maintenance setting a dose escalation scheme based on the BOIN design will be applied as outlined (TBD) with a maximal dose of venetoclax 400 mg QD and navitoclax 50mg QD according to the RP2D presented by Pullarkat et al. (Cancer Discov . 2021 Feb 16;candisc.1465.2020. doi: 10.1158/2159-8290.CD-20-1465).

Publications & conference data

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

The Emerging Role of Venetoclax-Based Treatments in Acute Lymphoblastic Leukemia.
Aumann S, Shaulov A, Haran A, Gross Even-Zohar N, et al · · 2022 · cited 30× · PMID 36142863 · DOI 10.3390/ijms231810957
Chimeric Antigen Receptor Based Cellular Therapy for Treatment Of T-Cell Malignancies.
Polgárová K, Otáhal P, Šálek C, Pytlík R. · · 2022 · cited 14× · PMID 35600381 · DOI 10.3389/fonc.2022.876758
Overcoming Steroid Resistance in Pediatric Acute Lymphoblastic Leukemia-The State-of-the-Art Knowledge and Future Prospects.
Kośmider K, Karska K, Kozakiewicz A, Lejman M, et al · · 2022 · cited 12× · PMID 35409154 · DOI 10.3390/ijms23073795
Targeting Leukemia-Initiating Cells and Leukemic Niches: The Next Therapy Station for T-Cell Acute Lymphoblastic Leukemia?
Zhang Z, Yang K, Zhang H. · · 2022 · cited 8× · PMID 36428753 · DOI 10.3390/cancers14225655
BCL-2 and BCL-xL in Cancer: Regulation, Function, and Therapeutic Targeting.
Silva JPN, Pinto B, Silva PMA, Bousbaa H. · · 2026 · cited 1× · PMID 41596764 · DOI 10.3390/ijms27021123
Promising Drugs Targeting Specific Mechanisms of Deregulation in T Cell Lineage Acute Lymphoblastic Leukemia.
Thomas X. · · 2025 · cited 1× · PMID 40249557 · DOI 10.1007/s40487-025-00339-1

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

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
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT05621291 — A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Follo · NA · recruiting
NCT07356154 — A Study of Revumenib and Mezigdomide in People With Leukemia · Phase 1, PHASE2 · recruiting
NCT07479927 — Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Alloge · NA · recruiting

Other Israeli Medical Association trials

Trials by the same sponsor.

NCT04334993 — Pediatric-type Therapy With Pre-transplant Blinatumomab for HR Patients - Phase II Study · Phase 2 · unknown

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 NCT05054465 (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 Israeli Medical Association
Last refreshed: 23 September 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/NCT05054465.

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