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AzTrials

Precursor Cell Lymphoblastic Leukemia-LymphomaPhase 2NCT05660473

Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

A Phase 2 study testing Vincristine, Daunorubicin and Cyclophosphamide in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Read more about this study

Who is it for?
Ages 14 to 60 years
What is being tested?
Vincristine, Daunorubicin and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Aug 2022to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification
  • Age: 14 -60 years
  • Male or female
  • ECOG Performance Status 0-2
  • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%;
  • Subject has provided written informed consent prior to any screening procedure

Who cannot join

  • Burkitt lymphoma/leukemia
  • Acute Leukemia of Ambiguous Lineage
  • Female patients who are pregnant or breast feeding
  • Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
  • History of pancreatitis
  • Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of >7.5%. Patients with preexisting, well-controlled diabetes are not excluded
Show all 10Show fewer
  • History of active gastrointestinal bleeding within the last 6 months
  • History of arterial/venous thrombosis within the last 6 months
  • Known HIV seropositivity
  • Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianxiang Wang, Dr contact

86-22-23909120

wangjx@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

    Jianxiang Wang, Dr., 86-22-23909120, wangjx@medmail.com.cn

    Jianxiang Wang, Dr.

    Recruiting

Other trials in China

About this study

The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.

Being tested
Vincristine, Daunorubicin, Cyclophosphamide, Pegaspargase, Prednisone
Keywords
Philadelphia Chromosome-Negative, Acute Lymphoblastic Leukemia, Adolescent and Adult, Pediatric-inspired Regimen, Venetoclax
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VincristineDrug

    Anti-tumor alkaloids

  • DaunorubicinDrug

    Anthracycline

  • CyclophosphamideDrug

    Alkylating agent

  • PegaspargaseDrug

    Polyethylene glycol (PEG) conjugated to L-asparaginase

  • PrednisoneDrug

    Glucocorticoids

  • CytarabineDrug

    Pyrimidine antimetabolites

  • 6-mercaptopurineDrug

    Cell cycle-specific antitumor drug

  • DexamethasoneDrug

    Glucocorticoids

  • MethotrexateDrug

    Antifolate antineoplastic drug

  • VenetoclaxDrug

    Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

Study groups in NCT05660473
Study groupRoleWhat they receive
Pediatric-inspired Regimen Combined With VenetoclaxExperimentalInduction therapy is administered as follows：Vincristine (VCR) 1.4 mg/m2 (maximum dose 2 mg) IV on D1,8,1,5,22; Daunorubicin (DNR) 30 mg/m2/day IV on D1-3; Cyclophosphamide (CTX) 1200 mg/m2 IV on D1,15; Pegaspargase 2500u/m2 IM on D5; Prednisone 1 mg/kg/d PO on D1-14, 0.5 mg/kg/d PO on D15-28; Venetoclax 100 mg PO on D6，200 mg on D7, 400mg on D8-14, All patients underwent bone marrow aspiration on day 14 during induction. Patients with bone marrow blasts ≥10% on day 14 of induction received 7 additional days of Venetoclax on day 15-22. Consolidation therapy is a combination of multi-drug pediatric-inspired regimen chemotherapy and Venetoclax. Maintenance therapy consisted of a monthly VMMP regimen (vincristine, mercaptopurine, methotrexate, prednisone) continuing until 3 years for male and 2.5 years for female patients.
Receives: Drug: Vincristine; Drug: Daunorubicin; Drug: Cyclophosphamide; Drug: Pegaspargase; Drug: Prednisone; Drug: Cytarabine; Drug: 6-mercaptopurine; Drug: Dexamethasone; Drug: Methotrexate; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRD-negative complete remission rate measured by flow cytometry

    Measured: After induction (4 week)

Secondary outcomes (5)

  1. Complete remission (CR) rate

    Measured: After 2 cycles of chemotherapy, an expected average of 3 months

  2. Overall survival (OS)

    From the date of registration to the date of death resulting from any cause

    Measured: Up to 5 years post-registration

  3. Relapse free survival (RFS)

    From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day

    Measured: Up to 5 years post-registration

  4. Disease-free Survival (DFS)

    From CR1 to relapse, death from any cause or last follow-up

    Measured: Up to 5 years post-registration

  5. The rate of adverse events

    Measured: An expected average of 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start1 Aug 2022
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660473
Sponsor's protocol ID
IIT2022052
Status last verified
May 2025
First submitted
13 Dec 2022
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gong X, Liu Y, Fang Q, Gu R, Liu K, Lin D, Zhou C, Zhang G, Gong B, Wei S, Li Y, Li S, Wang Y, Qiu S, Liu B, Wang Y, Mi Y, Wei H, Wang J. Venetoclax Plus Pediatric Regimen in Adolescents and Adults with Ph-Negative Acute Lymphoblastic Leukemia. Blood. 2026 May 21:blood.2026033577. doi: 10.1182/blood.2026033577. Online ahead of print.

    PubMed 42166560

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vincristine, Daunorubicin and Cyclophosphamide in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianxiang Wang, Dr (86-22-23909120, wangjx@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD-negative complete remission rate measured by flow cytometry (time frame: After induction (4 week)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05660473, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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