Who is sponsoring NCT03349281?

NCT03349281 is sponsored by Julio Barredo, MD.

What drugs are being tested in NCT03349281?

Interventions in NCT03349281: Pevonedistat, Vincristine, Dexamethasone, PEG-asparaginase, Doxorubicin, Cytarabine, Methotrexate, Hydrocortisone.

What condition does NCT03349281 study?

NCT03349281 studies Refractory Acute Lymphoblastic Leukemia, Relapsed Acute Lymphoblastic Leukemia.

Is NCT03349281 still recruiting?

NCT03349281 is currently completed. Last updated 20 October 2022.

Last reviewed 2022-10-20 · How we verify

NCT03349281

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

Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL

Completed Phase 1 Last updated 20 October 2022

What this trial tests

Phase 1 trial testing Pevonedistat in Refractory Acute Lymphoblastic Leukemia in 6 participants. Completed in 12 October 2022.

Timeline

25 March 2019

Primary endpoint
11 August 2021

12 October 2022

Quick facts

Lead sponsor	Julio Barredo, MD
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	25 March 2019
Primary completion	11 August 2021
Estimated completion	12 October 2022
Sites	1 location across United States

Drugs / interventions tested

Pevonedistat
Vincristine (vincristine) — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
PEG-asparaginase
Doxorubicin (doxorubicin) — full drug profile →
Cytarabine — full drug profile →
Methotrexate
Hydrocortisone (hydrocortisone) — full drug profile →

Conditions studied

Refractory Acute Lymphoblastic Leukemia — all drugs for Refractory Acute Lymphoblastic Leukemia →
Relapsed Acute Lymphoblastic Leukemia — all drugs for Relapsed Acute Lymphoblastic Leukemia →

Sponsor

Julio Barredo, MD

Who can join

Adults 16 to 39, any sex, with Refractory Acute Lymphoblastic Leukemia or Relapsed Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators postulate that Pevonedistat will be effective in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) when combined with a standard backbone ALL chemotherapy regimen.

Publications & conference data

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

Ubiquitination and deubiquitination in cancer: from mechanisms to novel therapeutic approaches.
Liu F, Chen J, Li K, Li H, et al · · 2024 · cited 195× · PMID 39048965 · DOI 10.1186/s12943-024-02046-3
Targeting NEDD8-activating enzyme for cancer therapy: developments, clinical trials, challenges and future research directions.
Fu DJ, Wang T. · · 2023 · cited 45× · PMID 37525282 · DOI 10.1186/s13045-023-01485-7
Transcription Factors: The Fulcrum Between Cell Development and Carcinogenesis.
Islam Z, Ali AM, Naik A, Eldaw M, et al · · 2021 · cited 38× · PMID 34195082 · DOI 10.3389/fonc.2021.681377
The Unfolded Protein Response: A Novel Therapeutic Target in Acute Leukemias.
Martelli AM, Paganelli F, Chiarini F, Evangelisti C, et al · · 2020 · cited 35× · PMID 32024211 · DOI 10.3390/cancers12020333
Targeting cullin neddylation for cancer and fibrotic diseases.
He ZX, Yang WG, Zengyangzong D, Gao G, et al · · 2023 · cited 33× · PMID 37771770 · DOI 10.7150/thno.78876
Molecular Approaches to Treating Pediatric Leukemias.
Kuhlen M, Klusmann JH, Hoell JI. · · 2019 · cited 33× · PMID 31555628 · DOI 10.3389/fped.2019.00368
Harnessing DNA Replication Stress for Novel Cancer Therapy.
Zhu H, Swami U, Preet R, Zhang J. · · 2020 · cited 30× · PMID 32854236 · DOI 10.3390/genes11090990
The Ubiquitin Proteasome System in Genome Stability and Cancer.
Morgan JJ, Crawford LJ. · · 2021 · cited 28× · PMID 34066546 · DOI 10.3390/cancers13092235

Verify or expand the search:

Other trials of Pevonedistat

Trials testing the same drug.

NCT04985656 — A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes · Phase 2 · withdrawn
NCT04800627 — Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor · Phase 1, PHASE2 · terminated
NCT04712942 — Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat · Phase 2 · completed
NCT04266795 — A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable · Phase 2 · completed
NCT03965689 — Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell · Phase 2 · active not recruiting

Other recruiting trials for Refractory Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

NCT07166419 — Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory N · Phase 1 · recruiting
NCT07070323 — A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/R · Phase 1, PHASE2 · recruiting
NCT06447987 — Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-C · Phase 1 · recruiting
NCT06581081 — Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cel · NA · recruiting
NCT06316856 — CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies · Phase 1, PHASE2 · 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 NCT03349281 (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 Julio Barredo, MD
Last refreshed: 20 October 2022

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/NCT03349281.

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