CClinicalTrials.gg
Not yet recruitingNCT05931757Updated Jul 5, 2023

A Study of Olverembatinib Combined With Blinatumomab in the Treatment of Ph+ ALL

A Phase 2 interventional study of Olverembatinib in Philadelphia-Positive ALL, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

This is a multicenter, prospective, phase II study for adult de novo Philadelphia chromosome-positive acute lymphoid leukemia (Ph+ ALL) based on the combination of Olverembatinib and Blinatumomab. Olverembatinib will be taken 40mg qod from the time of diagnosis, and Blinatumomab will be given intravenously up to five cycles.

Read the detailed description

This is a prospective, multicenter, one-arm phase II clinical study, aimed for evaluating the effectiveness and safety of Olverembatinib combined with Blinatumomab in the treatment of newly diagnosed adult Ph + ALL patients.

Subjects enrolled in this study will be given a 14-day induction regimen of Olverembatinib 40mg qod orally combined with blinatumomab. To prevent cytokine release syndrome (CRS), the subjects are permitted to receive pretreatment with dexamethasone combined with Olverembatinib until the leukocyte count is less than 5 × 109/L. During induction therapy, Blinatumomab will be given in an incremental dose regimen, i.e., 9 μ g/day on days 1 to 3 and 28 μ g/day was used on days 4 to 14, and then stopped for 14 days.

Olverembatinib 40mg qod combined with blinatumomab will subsequently administered as a consolidation regimen. Blinatumomab was given a fixed dose regimen during consolidation treatment, i.e. 28 μ g/day from the day 1 to the day 28, and then stopped for 14 days. A total of 3-4 cycles will be administered, with every 42 days as one cycle.

At the end of the consolidation treatment, the patient received a maintenance regimen of Olverembatinib 40mg qod orally for at least 5 years. If the patient loses molecular response (defined as BCR-ABL1/ABL1 > 0.10%) during maintenance treatment, another consolidation treatment of 3-4 cycles of blinatumomab will be initiated.

During induction and consolidation treatment, lumbar puncture combined with sheath injection will be performed three times every cycle to prevent central nervous system leukemia (CSNL). If CNSL occurs at the time of admission, patients should receive regular conventional lumbar puncture and sheath injection for treating CNSL.

During the treatment, each subject will be evaluated regularly, including hematological response, minimal residual disease (through flow cytology, FCM-MRD), cytogenetic response and molecular remission rate, as well as adverse events.

02

Conditions studied

  • Philadelphia-Positive ALL
03

In context

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
  2. 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.
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
  4. 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.
  1. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion criteria

Exclusion Criteria:

  1. Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCVpositive).
  2. Uncontrolled active infection.
  3. Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS.
  4. 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.
  5. Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is >50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension.
  6. Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL.
  7. Patients who have any other malignant tumors that require treatment.
  8. Patients who have a history of pancreatitis or a history of alcohol abuse.
  9. Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L).
  10. Patients who are pregnant, planning to become pregnant or breastfeeding.
  11. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug.
  12. 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.
  13. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    The patients would be treated with Olverembatinib, Given PO, combined with Blinatumomab, Given intravenously

    Drug: Olverembatinib

Interventions

  • DrugOlverembatinib

    Olverembatinib will be taken 40mg qod from the time of diagnosis, and Blinatumomab will be given intravenously up to five cycles.

    Also known as: Blinatumomab

06

What researchers measure

Primary outcomes

  1. Number of Participants with Complete Molecular Remission.

    Will be estimated along with the 95% credible intervals.

    Time frame: From Induction through the end of three cycles of blinatumomab (approximately 16 weeks)

Secondary outcomes

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

    Will be estimated along with the 95% credible intervals.

    Time frame: From Induction through the end of three cycles of blinatumomab (approximately 16 weeks)

  2. Duration of Complete Molecular Remission.

    Will be estimated along with the 95% credible intervals.

    Time frame: From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 to 7 years.

  3. Event-free survival (EFS)

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

    Time frame: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 7 years

  4. Overall survival (OS)

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

    Time frame: From the first day of treatment to time of death from any cause, assessed up 2 to 7 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.

    Time frame: Up to approximately 2 to 7 years

07

Study locations

1 site
  • First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05931757
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Chen Suning (Principal Investigator, The First Affiliated Hospital of Soochow University) — Principal investigator
First posted
Jul 5, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jul 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion