Last reviewed · How we verify

NCT05576532

Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia

Status unknown Phase 2 Last updated 28 June 2023
What this trial tests

Phase 2 trial testing BCL2 Inhibitor plus IM2 regimen in T-lymphoblastic Lymphoma in 30 participants. Status unknown.

Timeline
10 January 2023
Primary endpoint
10 October 2024
10 October 2025

Quick facts

Lead sponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date10 January 2023
Primary completion10 October 2024
Estimated completion10 October 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Adults 14 to 45, any sex, with T-lymphoblastic Lymphoma or Relapsed Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety and efficacy of Venetoclax plus IM2 regimen for relapsed and refractory T lymphoblastic lymphoma/leukemia. Dosage of Venetoclax:100mg/d-400mg/d(dose adjustment when concomitant used with CYP3A inhibitor) for 1-28 days (at least 7 days); IM2 regimen: Ifosfamide 1-1.5g/m2/d for 5 days; Mitoxantrone 6-8g/m2/d for 3 days( or Liposome mitoxantrone 20mg/m2 d1 or Idarubicin 6-8mg/m2/d for 3 days) ;methotrexate 1-1.5g/m2/d for 1 day;

Publications & conference data

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

  1. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.
    Domingues C, Jarak I, Veiga F, Dourado M, et al · · 2023 · cited 33× · PMID 37896191 · DOI 10.3390/pharmaceutics15102431
  2. Mitochondria and Acute Leukemia: A Clinician's Perspective.
    Iyer P, Jasdanwala SS, Bhatia K, Bhatt S. · · 2024 · cited 6× · PMID 39273651 · DOI 10.3390/ijms25179704
  3. B-Cell Lymphoma 2 Inhibition in Acute Lymphoblastic Leukemia: Mechanisms, Resistance, and Emerging Combinations With Venetoclax.
    Hanbali A, Kotb A, Saleh M. · · 2025 · cited 1× · PMID 40904937 · DOI 10.14740/jh2092
  4. The use of venetoclax in the treatment of acute lymphoblastic leukemia-a systematic review.
    Kowalczyk A, Zarychta J, Zawitkowska J, Lejman M. · · 2026 · PMID 41523908 · DOI 10.1177/17588359251403912

Verify or expand the search:

Other recruiting trials for T-lymphoblastic Lymphoma

Currently open trials in the same condition.

Other Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05576532.

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