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Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

ConditionPrecursor Cell Lymphoblastic Leukemia-Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification

Age: 14 -60 years

Male or female

ECOG Performance Status 0-2

Disqualifiers

Burkitt lymphoma/leukemia

Acute Leukemia of Ambiguous Lineage

Female patients who are pregnant or breast feeding

Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • Vincristine

    Drug

    Anti-tumor alkaloids

  • Daunorubicin

    Drug

    Anthracycline

  • Cyclophosphamide

    Drug

    Alkylating agent

  • Pegaspargase

    Drug

    Polyethylene glycol (PEG) conjugated to L-asparaginase

  • Prednisone

    Drug

    Glucocorticoids

  • Cytarabine

    Drug

    Pyrimidine antimetabolites

  • 6-mercaptopurine

    Drug

    Cell cycle-specific antitumor drug

  • Dexamethasone

    Drug

    Glucocorticoids

  • Methotrexate

    Drug

    Antifolate antineoplastic drug

  • Venetoclax

    Drug

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Pediatric-inspired Regimen Combined With VenetoclaxExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

MRD-negative complete remission rate measured by flow cytometry

Time frame
After induction (4 week)

Secondary outcomes

1

Complete remission (CR) rate

Time frame
After 2 cycles of chemotherapy, 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 the last follow-up day

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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