Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06387121

Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Adult Patients With Ph-negative B-cell Acute Lymphoblastic Leukemia

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-17

53

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment approach for adults newly diagnosed with Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. Despite advances in chemotherapy and immunotherapy, treatment results remain less than ideal, especially for patients who cannot safely receive intensive therapies due to other health issues. This study aims to improve outcomes by combining immunotherapy drugs with low-dose chemotherapy to increase complete remission rates and reduce relapse risk. This open-label, single-arm Phase II clinical trial involves 53 adult patients with Ph- B-ALL. Participants receive induction therapy cycles that include immuno-targeted drugs such as Inotuzumab ozogamicin and Blinatumomab, combined with low-dose chemotherapy agents like vincristine, cyclophosphamide, dexamethasone, methotrexate, and cytarabine, along with Venetoclax. Consolidation and maintenance therapies continue with low-dose chemotherapy, Blinatumomab, and Venetoclax. When possible, patients may also receive CAR-T cell therapy or hematopoietic stem cell transplantation during their first complete remission. Participants will undergo assessments including measurable residual disease (MRD) testing by flow cytometry after induction therapy to evaluate remission status. The study monitors survival outcomes such as overall survival, relapse-free survival, and disease-free survival for up to five years after treatment. Safety is observed throughout, and patients are followed for at least five years post-maintenance therapy to track long-term effects and disease control.

CONDITIONS

Brief Title

Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2016 criteria
  • CD22 positive tumor cells
  • 18 years of age or older
  • Estimated survival of at least 3 months
  • Consent and effective contraception for men and women of childbearing potential
  • Understanding and signing of informed consent forms and agreement to comply with study requirements
Not Eligible

You will not qualify if you...

  • Burkitt lymphoma/leukemia
  • Acute leukemias of ambiguous lineage
  • Pregnant women
  • Severe uncontrolled active infection
  • Previous history of chronic liver disease such as cirrhosis, venous occlusive liver disease, or sinus obstruction syndrome
  • History of significant ventricular arrhythmia, unexplained syncope, sinoatrial block, higher degree atrioventricular block, or chronic bradycardia without pacemaker
  • New or chronic hepatitis B or C infection or known HIV positive status
  • Psychiatric disorders likely to prevent completion of treatment or informed consent
  • Other conditions considered unsuitable for the study by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Induction therapy cycles lasting approximately 4 weeks followed by consolidation and maintenance therapy lasting several months

Participants receive cycles of low-dose chemotherapy combined with immuno-targeted drugs and Venetoclax as induction therapy, followed by consolidation and maintenance therapy. Some participants may receive CAR-T Immunotherapy or hematopoietic stem cell transplantation during first complete remission if possible.

Multiple visits during approximately 4 weeks of induction therapy and additional visits for consolidation and maintenance therapy

Follow-up

Duration - At least 5 years

Participants are followed for safety and long-term outcomes including overall survival and relapse-free survival for at least 5 years after completing maintenance therapy.

Periodic visits during follow-up period

Trial Site Locations

Total: 1 location

1

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

J

Jianxiang Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials.

Nicolas Boissel, Marie-Françoise Auclerc, Véronique Lhéritier...

https://pubmed.ncbi.nlm.nih.gov/12610173

Results of the hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone regimen in elderly patients with acute lymphocytic leukemia.

Susan O'Brien, Deborah A Thomas, Farhad Ravandi...

https://pubmed.ncbi.nlm.nih.gov/18720356