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

ConditionPrecursor Cell Lymphoblastic Leukemia-Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens. In recent years, tumor immunotherapy has demonstrated promising safety and efficacy profiles in refractory or relapsed Ph- B-ALL across a wide spectrum of adult ages. These findings suggest that broader application of immunotherapy may represent a critical strategy to improve survival in this population. In this study, we propose a regimen that combines immuno-targeted agents with low-intensity chemotherapy for newly diagnosed adult patients with Ph- B-ALL. Our primary objective is to increase the rate of measurable residual disease (MRD)-negative complete remission (CR) following induction therapy, reduce the risk of relapse, and ultimately enhance overall survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria

CD22 positive tumor cells

≥18 years of age

Estimated survival ≥3 months

Disqualifiers

Burkitt lymphoma/leukemia

acute leukemias of ambiguous lineage

pregnant women

severe uncontrolled active infection

Trial design

Design model

Single group

Treatments tested in this trial

  • Vincristine

    Drug

    Anti-tumor alkaloids

  • Cyclophosphamide

    Drug

    Alkylating agent

  • Dexamethasone

    Drug

    Glucocorticoids

  • Venetoclax

    Drug

    Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

  • Inotuzumab ozogamicin

    Drug

    A humanized monoclonal antibody-drug conjugate targeting CD22

  • Blinatumomab

    Drug

    Bi-specific anti-CD19/CD3 antibodies

  • 6-mercaptopurine

    Drug

    Cell cycle-specific antitumor drug

  • Methotrexate

    Drug

    Antifolate antineoplastic drug

  • Cytarabine

    Drug

    Pyrimidine antimetabolites

  • Prednisone

    Drug

    Glucocorticoids

Treatment groups

53 Participants
are divided into 2 treatment groups
Group A: low-dose chemotherapy, Venetoclax combined with immuno-targeted drugsExperimental treatment 10 interventions
Group B: low-dose chemotherapy combined with VenetoclaxExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

MRD-negative complete remission rate measured by flow cytometry.

No immature cells were detected by flow cytometry when CR criteria were met after induction therapy.

Time frame
After induction (4 week)

Secondary outcomes

1

Complete remission (CR) rate

Time frame
an expected average of 3 months
2

Overall survival (OS)

From the date of registration to the date of death resulting from any cause.

Time frame
Up to 5 years post-registration
3

Relapse free survival (RFS)

From the date of complete remission (CR) until the date of documented relapse or death due to any cause or last follow-up.

Time frame
Up to 5 years post-registration
4

Disease-free Survival (DFS)

From CR1 to relapse, death from any cause or last follow-up.

Time frame
Up to 5 years post-registration

Other outcomes

Sponsors and contacts

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

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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