Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus... | NCT06578546

Studies
Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL

NCT06578546

Sponsor

The First Affiliated Hospital of Soochow University

Status

Unknown status

Last Update Posted

Aug 29, 2024Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Ph-Positive Acute Lymphoblastic Leukemia

Interventions

Venetoclax
Azacitidine
Orebatinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Feb 1, 2025Estimated

Completion Date

Feb 1, 2026Estimated

First Submitted Date

Apr 27, 2024

First Submission Date that Met QC Criteria

Aug 27, 2024

First Posted Date

Aug 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2024

Last Update Posted Date

Aug 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia.

Detailed Description

This is a phase Ⅱ, single-arm, open Label, multicenter clinical study in newly diagnosed Ph-positive acute lymphoblastic leukemia patients. The patients will receive venetoclax, azacitidine and orebatinib regimen in the induction treatment. The patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Venetoclax, Azacitidine, and Orebatinib Regimen	Experimental	See Detailed Description.	Drug: Venetoclax Drug: Azacitidine Drug: Orebatinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venetoclax	Drug	100mg d1, 200mg d2, 400mg d2-21, oral (Adjusted according to the plasma concentration of venetoclax on day 4)，every 28 days for a treatment cycle.	Venetoclax, Azacitidine, and Orebatinib Regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete molecular remission（CMR）	Proportion of patients achieving CMR at the end of 1 or 2 cycles	End of cycle 1 and 2 (each cycle is 28 days)

Secondary Outcomes

Measure	Description	Time Frame
CR	Complete remission (CR) was defined as < 5% bone marrow blasts in an aspirate with spicules and independent of transfusions.	End of cycle 1 and 2 (each cycle is 28 days)
CRi	CR with incomplete hematologic recovery (CRi) was defined as <5% bone marrow blasts, either ANC<1×10^9/L or platelets < 100×10^9/L, transfusion independence but with persistence of cytopenia.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
Age ≥18.
Eastern Cooperative Oncology Group (ECOG) score: 0-3.
Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
Creatinine clearance ≥ 30 mL/min.
Serum lipase ≤ 1.5 x ULN, amylase =< 1.5 x ULN.
Provide informed consent.

Exclusion Criteria:

Patients with another malignant disease.
Patients with uncontrolled active infection.
Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
Patients with uncontrolled active bleeding.
Patients who has participated or participating in other clinical trials related to this disease.
Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
Patients with other commodities that the investigators considered not suitable for the enrollment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaowen Tang, Ph.D	Contact	67781525		xwtang1020@163.com
Depei Wu, Ph.D	Contact	67781856		drwudepei@163.com

Overall Officials

Name	Affiliation	Role
Xiaowen Tang, Ph.D	The First Affiliated Hospital of Soochow University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Soochow University	Recruiting	Suzhou	Jiangsu	215006	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides