NCT05190549 is a Phase 2 clinical trial of CAV regimen bridging to HSCT in Acute Leukemia, Relapsed, sponsored by The First Affiliated Hospital of Soochow University.

Who is sponsoring NCT05190549?

NCT05190549 is sponsored by The First Affiliated Hospital of Soochow University.

What drugs are being tested in NCT05190549?

Interventions in NCT05190549: CAV regimen bridging to HSCT.

What condition does NCT05190549 study?

NCT05190549 studies Acute Leukemia, Relapsed, Acute Leukemia Refractory.

Is NCT05190549 still recruiting?

NCT05190549 is currently completed. Last updated 20 November 2024.

Last reviewed 2024-11-20 · How we verify

NCT05190549

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

CAV Regimen Bridging to HSCT for R/R AL

Completed Phase 2 Last updated 20 November 2024

What this trial tests

Phase 2 trial testing CAV regimen bridging to HSCT in Acute Leukemia, Relapsed in 30 participants. Completed in 17 November 2024.

Timeline

1 October 2021

Primary endpoint
17 November 2024

17 November 2024

Quick facts

Lead sponsor	The First Affiliated Hospital of Soochow University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 October 2021
Primary completion	17 November 2024
Estimated completion	17 November 2024
Sites	1 location across China

Drugs / interventions tested

CAV regimen bridging to HSCT

Conditions studied

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

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

Adults 16 to 70, any sex, with Acute Leukemia, Relapsed or Acute Leukemia Refractory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although allogeneic hematopoietic stem cell transplantation (HSCT) is a curative treatment option for acute leukemia (AL), relapsed or refractory (R/R) AL is still a big challenge. It is believed that decreased tumor burden before HSCT is a favorable factor contributing to the long-term survival of R/R AL patients and many kinds of bridging chemotherapy regimens were devised to kill leukemic cells before HSCT, there is still no consensus that which regimen is optimal. This study is to investigate the curative efficacy and safety of bridging CAV (cladribine combined with low dose Ara-C and venetoclax) regimens followed by HSCT treatment protocol for R/R AML.

Publications & conference data

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

Efficacy and safety of cladribine, low-dose cytarabine and venetoclax in relapsed/refractory acute myeloid leukemia: results of a pilot study.
Li YY, Ge SS, Huang YH, Xu MZ, et al · · 2024 · cited 14× · PMID 38238305 · DOI 10.1038/s41408-024-00982-3
Cladribine plus cytarabine plus venetoclax in acute myeloid leukemia relapsed or refractory to venetoclax plus hypomethylating agent.
Steinauer N, McCullough K, Al-Kali A, Alkhateeb HB, et al · · 2024 · cited 5× · PMID 38546692 · DOI 10.3324/haematol.2024.284962
Efficacy and prognostic analysis of venetoclax combined with hypomethylating agents for induction therapy in acute myeloid leukemia: a multi-center real-world study on indication-specific stratification, molecular markers, and hematologic toxicities.
Xia L, Qu M, Ge L, Chen Y, et al · · 2025 · cited 1× · PMID 40598544 · DOI 10.1186/s12935-025-03858-z
Venetoclax-based therapy for relapsed or refractory acute myeloid leukemia: latest updates from the 2022 ASH annual meeting.
Gong X, Zhang Y, He X, Moloudizargari M, et al · · 2023 · cited 1× · PMID 37391809 · DOI 10.1186/s40164-023-00424-z

Verify or expand the search:

Other The First Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

NCT07350863 — U69-CART-Cells For R/R T-ALL · Phase 1 · recruiting
NCT06985498 — Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL · Phase 2 · not yet recruiting
NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
NCT07511426 — U96-CAR-T-Cells For R/R B-ALL · Phase 1 · 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 NCT05190549 (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 The First Affiliated Hospital of Soochow University
Last refreshed: 20 November 2024

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/NCT05190549.

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