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NCT06754267
Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph-positive Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study
Phase 2 trial testing Venetoclax in Precursor B-Cell Acute Lymphoblastic Leukemia in 36 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 December 2024 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Venetoclax (venetoclax) — full drug profile →
- Olverembatinib — full drug profile →
- Predinisone — full drug profile →
Conditions studied
- Precursor B-Cell Acute Lymphoblastic Leukemia — all drugs for Precursor B-Cell Acute Lymphoblastic Leukemia →
Sponsor
First Affiliated Hospital of Zhejiang University
Who can join
18 and older, any sex, with Precursor B-Cell 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.
-
complete molecular response (CMR) after three cycles
Time frame: At the end of Cycle 3(each cycle is 28 days)
BCR::ABL1≤0.01% detected by RT-qPCR
Sponsor's own description
Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Philadelphia chromosome positive (Ph+) ALL is defined as ALL with translocation between chromosomes 9 and 22. And t(9;22)(q34;q11) is the most common chromosomal abnormality in ALL. Before the emergence of TKI, the prognosis of Ph+ ALL was extremely poor, and the long-term survival rate was only 10%-35%. Ph+ ALL accounts for about 30% of adult ALL. In this study, the investigators propose a treatment approach that combines Venetoclax with Olverembatinib and Predinisone in Ph+ B-ALL adults. The study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Olverembatinib (HQP1351): a third-generation tyrosine kinase inhibitor in the treatment of hematologic and solid malignancies-a comprehensive review of clinical outcomes.
Sadati S, Yazdizadeh S, Razavi SM, Homayoonfal M, et al · · 2026 · PMID 41547674 · DOI 10.1007/s12672-026-04438-x -
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 NCT06754267
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Venetoclax
Trials testing the same drug.
- NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients · Phase 2, PHASE3 · not yet recruiting
- NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting
- NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
- NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
- NCT07511062 — Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML · Phase 1 · not yet recruiting
Other recruiting trials for Precursor B-Cell Acute Lymphoblastic Leukemia
Currently open trials in the same condition.
- NCT06742515 — Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL · Phase 2 · recruiting
- NCT04629729 — FT819 in Subjects With B-cell Malignancies · Phase 1 · active not recruiting
Other First Affiliated Hospital of Zhejiang University trials
Trials by the same sponsor.
- NCT07537192 — Inulin-Spirulina Co-intervention for Insomnia Disorder · NA · not yet recruiting
- NCT07510867 — 18F-FAPI PET/CT and MRI in Gastric Cancer · not yet recruiting
- NCT07589647 — Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic D · NA · recruiting
- NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
- NCT07468162 — Characteristic Electroencephalogram of General Anesthesia · not yet 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 NCT06754267 (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 First Affiliated Hospital of Zhejiang University
- Last refreshed: 23 December 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/NCT06754267.
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