Last reviewed · How we verify
NCT05657652
Venetoclax, Cladribine Plus Low-dose Cytarabine for Relapsed/Refractory Philadelphia Chromosome-negative (Ph-) B-cell Acute Lymphoblastic Leukemia (B-ALL): a Single-arm, Multicenter Study
NA trial testing cladribine, cytarabine,venetoclax in Acute Lymphoblastic Leukemia in 36 participants. Currently enrolling.
1 October 2026
Quick facts
| Lead sponsor | The First Affiliated Hospital of Soochow University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 October 2022 |
| Primary completion | 1 October 2026 |
| Estimated completion | 1 October 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- cladribine, cytarabine,venetoclax — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Sponsor
The First Affiliated Hospital of Soochow University
Who can join
Adults 15 to 70, any sex, with Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Overall response rate (ORR)
Time frame: ORR assessment is measured on days 21 from the start of CAV regimen
The overall response (completed remission, completed remission with incomplete blood count recovery)
Sponsor's own description
This study aims to investigate the efficacy and safety of cladribine, venetoclax combined with cytarabine and venetoclax (CAV regimen) for relapsed/refractory (R/R) Philadelphia Chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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:
- PubMed search for NCT05657652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 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)
- Trial protocol + status: ClinicalTrials.gov NCT05657652 (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: 21 December 2025
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/NCT05657652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing