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

ConditionPhiladelphia-Positive ALL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCVpositive).

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 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Olverembatinib

    Drug

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

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: