Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study

NCT06649422 | Not Yet Recruiting

• 1 other identifier: QLCR20240289
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.

Conditions

Leukemia, Lymphocytic, Acute, Adult

Keywords

blinatumomab; newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia; induction treatment; reduced-dose chemotherapy

Outcome Measures

Primary Outcomes (2)

• The overall response rate

  The overall response rate after induction therapy = Complete Remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (Cri).

  At the end of induction treatment from day 28 to day 35

• Minimal Residual Disease (MRD) negativity rate after induction therapy

  MRD negativity refers to a flow cytometry test result where MRD is less than 0.01%.

  At the end of induction treatment from day 28 to day 35

Secondary Outcomes (4)

• Complete molecular remission rate.

  At the end of induction treatment from day 28 to day 35

• One-year overall survival rate.

  From diagnosis of the disease to the end of the first year

• One-year event-free survival rate

  From diagnosis of the disease to the end of the first year

• Safety

  From enrollment until withdrawal from the study or the end of follow-up up to two years

Study Arms (1)

Reduced-dose chemotherapy followed by blinatumomab induction treatment group

Patients aged 15-65 with newly diagnosed Ph-negative B-ALL undergoing frontline induction therapy with reduced-dose chemotherapy followed by blinatumomab.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia.

Also known as: Combination chemotherapy with multiple drugs., preventive intrathecal injections

Reduced-dose chemotherapy followed by blinatumomab induction treatment group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 15-65 years newly diagnosed with Philadelphia chromosome-negative acute B-lymphoblastic leukemia, confirmed at Qilu Hospital of Shandong University and other participating institutions in Shandong Province.

You may qualify if:

• Age 15-65 years, both male and female are eligible;
• Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing \>20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and/or fluorescence in situ hybridization (FISH) BCR/ABL negative and/or molecular BCR/ABL fusion gene negative;
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
• Organ function tests must meet all the following criteria: Total bilirubin \<1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \<2.5×ULN (if liver is involved, then ALT and AST \<5×ULN are allowed); Creatinine \<1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits.
• Cardiac color Doppler echocardiography ejection fraction ≥45%;
• Female patients of childbearing potential must have a negative pregnancy test (within 7 days prior to enrollment).

You may not qualify if:

• Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;
• Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis;
• Patients participating in other clinical studies simultaneously;
• Accompanying diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the patient's ability to complete the study;
• A history of definite neurological or psychiatric disorders, including epilepsy or dementia;
• Major surgery within the last 4 weeks or not recovered from previous surgery;
• Having other malignant tumors, unless the other primary malignant tumor is currently stable or does not require active intervention;
• Women of childbearing age or men who cannot use sufficient methods for contraception, including pregnant or lactating women;
• Clinically significant severe uncontrollable heart disease (including but not limited to a history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months before enrollment; congestive heart failure or left ventricular ejection fraction (LVEF) below the local institutional standard lower limit within 6 months before enrollment; a history of clinically significant (determined by the attending physician) atrial arrhythmia; a history of ventricular arrhythmia; a history of venous thromboembolism, including deep vein thrombosis or pulmonary embolism, uncontrollable hypertension, etc.);
• Confirmed positive status for human immunodeficiency;
• Active severe infections that cannot be controlled by oral or intravenous antibiotics;
• Patients known to be allergic or contraindicated to the study drug (active pharmaceutical ingredient and/or excipients);
• Existence of bleeding disorders unrelated to ALL.

Sponsors & Collaborators

• Shandong University: lead
• Shandong Provincial Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Tangshan Central Hospital: collaborator
• Affiliated Central Hospital of Shandong First Medical University: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Qilu Hospital of Shandong University (Qingdao): collaborator
• Qingdao Central Hospital: collaborator
• Qingdao Municipal Hospital: collaborator
• The Affiliated Hospital of Jining Medical University and Zaozhuang City: collaborator
• Affiliated Hospital of Binzhou Medical College: collaborator
• Linyi People's Hospital: collaborator
• The Second Hospital of Shandong University: collaborator
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine: collaborator
• Shandong First Medical University: collaborator
• Shengli Oilfield Hospital: collaborator
• Heze Municipal Hospital: collaborator
• Zibo Central Hospital: collaborator
• Zaozhuang Municipal Hospital: collaborator
• Weihai Municipal Hospital: collaborator

MeSH Terms

Conditions

Leukemia

Interventions

blinatumomab; Drug Therapy, Combination

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Chunyan Ji, Doctor

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanping Sun

CONTACT

18560089133; syp215920@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: October 18, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 18, 2024

Record last verified: 2024-07