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Philadelphia-Positive ALLPhase 2NCT05466175

A Study of Olverembatinib in the Treatment of Ph+ ALL

A Phase 2 study testing Olverembatinib, Prednisone and Vincristine in people with Philadelphia-Positive ALL, run by Chen Suning at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of a novel third-generation TKI Olverembatinib. The main purpose of the study is to evaluate the efficacy and safety of Olverembatinib in Ph+ ALL patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Philadelphia-Positive ALL
What is being tested?
Olverembatinib, Prednisone and Vincristine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteChina
Study dates
1 Oct 2022to 30 Sep 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
  • Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy. Participants who only received preconditioning can be enrolled.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
  • Organ function as indicated by the following laboratory indicators must be met:
  • 1) Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN; 2) Total bilirubin≤1.5×ULN; 3) Serum creatinine≤1.5×ULN or 24-hour calculated creatinine clearance≥50mL/min when serum creatinine >1.5×ULN; 4) Amylase≤1.5×ULN, lipase≤1.5×ULN; 5) Cardiac ejection fraction (EF) > 50%, pulmonary artery systolic blood pressure ≤ 50mmHg; 6) QT interval corrected on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females; 7) PT, APTT and INR≤1.5×ULN.
  • 5. Willingness and ability to comply with study procedures and follow-up examination.

Who cannot join

  • The presence of central nervous system (CNS) or testicular active ALL.
  • Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
  • Uncontrolled active infection.
  • Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS.
  • Patients who have a history of clinically significant CNS lesions or is currently suffering from clinically significant CNS lesions.
  • Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) > 140mmHg and/or diastolic blood pressure > 90mmHg), or take medications that are known to cause QT interval prolongation. The patients with well controlled HBP can be considered to be included.
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  • Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is >50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension.
  • Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL.
  • Patients who have any other malignant tumors that require treatment.
  • Patients who have a history of pancreatitis or a history of alcohol abuse.
  • Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L).
  • Patients who are pregnant, planning to become pregnant or breastfeeding.
  • Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug.
  • Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures.
  • Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: A Multicenter, Prospective Clinical Study of Olverembatinib Combined With Chemotherapy in the Treatment of de Novo Adult Philadelphia Chromosome-positive Acute Lymphoid Leukemia

In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of a novel third-generation TKI Olverembatinib.

The main purpose of the study is to evaluate the efficacy and safety of Olverembatinib in Ph+ ALL patients.

Read the detailed description

Eligible participants will receive an 28-day induction regimen of Olverembatinib (40mg, QOD) combined with VP-chemotherapy, followed by 4 cycles of Hyper-CVAD A/B treatment (each lasting 28 days). If complete molecular response (CMR) is achieved at the 3rd month, participants will receive another three cycles of Hyper-CVAD A/B treatment. Maintenance therapy would be given for at least 1 year with monthly courses of vincristine, prednisone and Olverembatinib. If participants fail to achieve CMR at the 3rd month, or patients with an available matched donor had the option to proceed to allogeneic stem cell transplantation (allo-HSCT) at the discretion of the treating physician. Olverembatinib would be administered at the time of hematopoietic reconstruction for at least 1 year.

Intrathecal injection would be performed on day 15 of induction therapy and before each course of consolidation therapy to prevent central nervous system leukemia (CNSL).

It is expected that about 55 patients will take part in this study.

Being tested
Olverembatinib, Prednisone, Vincristine
Keywords
Olverembatinib, Ph+ALL, adult, de novo

What participants receive

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

Study groups in NCT05466175
Study groupRoleWhat they receive
Treatment GroupExperimentalcombination of Olverembatinib with chemotherapy
Receives: Drug: Olverembatinib; Drug: Prednisone; Drug: Vincristine

What is being measured

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

  1. Number of Participants with Complete Molecular Remission

    Will be estimated along with the 95% credible intervals.

    Measured: From Induction through the end of one cycle of Hyper-CVAD A and B (approximately 3 months) (Cycle length is equal to [=] 28 days) ]

Secondary outcomes (5)

  1. Percentage of Participants with CR and Incomplete Complete Remission (CRi)

    Will be estimated along with the 95% credible intervals.

    Measured: At the end of consolidation therapy (approximately 9 months) and one year after allo-HSCT

  2. Duration of Complete Molecular Remission

    Will be estimated along with the 95% credible intervals.

    Measured: From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 to 4 years.

  3. Event-free survival (EFS)

    The Kaplan-Meier method will be used to assess EFS probabilities.

    Measured: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 4 years ]

  4. Overall survival (OS)

    The Kaplan-Meier method will be used to assess OS probabilities.

    Measured: From the first day of treatment to time of death from any cause, assessed up 2 to 4 years.

  5. Incidence of adverse events (AEs)

    Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.

    Measured: Up to approximately 2 to 4 years

Timeline

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

  1. First posted20 Jul 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2024 (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
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05466175
Sponsor's protocol ID
SZ-ALL01
Status last verified
Jul 2022
First submitted
4 Jul 2022
Last updated
1 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olverembatinib, Prednisone and Vincristine in people with Philadelphia-Positive ALL, run by Chen Suning 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 15 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: status not confirmed, as of the sponsor's last update on 1 Sep 2022. 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?

Results are not available in the source record.

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?

Number of Participants with Complete Molecular Remission (time frame: From Induction through the end of one cycle of Hyper-CVAD A and B (approximately 3 months) (Cycle length is equal to [=] 28 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 NCT05466175.

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 Sep 2022.

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