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Philadelphia Chromosome Positive Acute Lymphoblastic LeukemiaPhase 2NCT05594784

Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL

A Phase 2 study testing Olverembatinib, Venetoclax and prednisone in people with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not available in mainland China. Read more about this study

Who is it for?
Ages 14 years and older
What is being tested?
Olverembatinib, Venetoclax and prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteChina
Study dates
8 Oct 2022to 25 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female patients aged 14 years or older
  • Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia; Patients will be diagnosed according to morphologic,immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular genetic (BCR/ABL gene, qualitative and quantitative analysis) examination
  • Eastern Cooperative Oncology Group (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

  • Lymphoid blast crisis of chronic myelocytic leukemia (CML)
  • Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment)
  • Clinical manifestations of CNS or extramedullary involvement with ALL
  • Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.)
  • Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
  • Known HIV seropositivity
Show all 11Show fewer
  • History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis
  • Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
  • Female patients who are pregnant or breast feeding
  • Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of >7.5%. Patients with preexisting, well-controlled diabetes are not excluded
  • 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.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

Other trials in China

About this study

Official title: Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Single-arm, Single-center Clinical Trial

The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not available in mainland China. Olverembatinib is the only third-generation TKI drug currently approved in mainland China. Venetoclax is an oral selective inhibitor of Bcl-2, and small exploratory clinical studies have demonstrated that venetoclax in combination with ponatinib showed high rates of CR as well as molecular response in relapsed/refractory Ph+ ALL. This study will explore the safety and efficacy of olverembatinib in combination with reduced-intensity chemotherapy and venetoclax in patients with newly diagnosed Ph+ ALL.

Being tested
Olverembatinib, Venetoclax, prednisone, Vincristine

What participants receive

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

  • OlverembatinibDrug

    a third-generation TKI

  • VenetoclaxDrug

    a selective inhibitor of B-cell lymphoma 2 (Bcl-2)

  • prednisoneDrug

    Glucocorticoids

  • VincristineDrug

    Anti-tumor alkaloids

Study groups in NCT05594784
Study groupRoleWhat they receive
Olverembatinib Combined With Reduced-Intensity Chemotherapy and VenetoclaxExperimentalFor Induction cycle, olverembatinib will be given orally 40mg every other day. Patients with CMR, olverembatinib will be reduced to 30 mg every other day. Induction and consolidation cycles combined with a certain period of venetoclax. Reduced-intensity chemotherapy regimens consist mainly of vincristine and prednisone. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients who keep BCR/ABL negative can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation chemotherapy.
Receives: Drug: Olverembatinib; Drug: Venetoclax; Drug: prednisone; Drug: Vincristine

What is being measured

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

  1. CMR rate

    Complete molecular remission rate (CMR rate) at 3 months of treatment (90 days)

    Measured: At 3 months of treatment (90 days)

Secondary outcomes (6)

  1. Overall survival(OS)

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

    Measured: up to 60 months

  2. Relapse free survival

    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 60 months

  3. The rate of adverse events

    Measured: an expected average of 24 months

  4. complete remission (CR) rate

    Measured: an expected average of 3 months

  5. The duration of CR

    Measured: up to 60 months

  6. The duration of molecular CR

    Measured: up to 60 months

Timeline

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

  1. First posted26 Oct 2022
  2. Study start8 Oct 2022
  3. Primary completion25 Mar 2025
  4. Study completion25 Mar 2025

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
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594784
Sponsor's protocol ID
IIT2022040
Status last verified
May 2024
First submitted
21 Oct 2022
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gong X, Liu W, Liu Y, Fang Q, Gu R, Liu K, Lin D, Zhou C, Zhang G, Gong B, Wei S, Li Y, Li S, Wang Y, Hu Y, Qiu S, Liu B, Wang Y, Mi Y, Wei H, Wang J. Olverembatinib combined with venetoclax and reduced-intensity chemotherapy for adult newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia: a single-center, single-arm, phase 2 trial. Leukemia. 2025 Aug;39(8):1838-1847. doi: 10.1038/s41375-025-02674-8. Epub 2025 Jun 30.

    PubMed 40588568

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olverembatinib, Venetoclax and prednisone in people with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia, 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 3 Jun 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CMR rate (time frame: At 3 months of treatment (90 days)). 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 NCT05594784, 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 3 Jun 2025.

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