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Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia

ConditionAcute Lymphoblastic Leukemia, Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL

Age ≥14 years, ≤60 years

ECOG performance status ≤2

Adequate organ function (liver, kidney, cardiac)

Disqualifiers

Burkitt leukemia/lymphoma

Acute leukemia of ambiguous lineage

Pregnancy or lactation

Severe uncontrolled active infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • VDCLP+V

    Drug

    Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.

  • 2VIP

    Drug

    Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.

  • Consolidation Therapy

    Drug

    Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate.

  • Maintenance Therapy

    Drug

    Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax.

  • Blinatumomab

    Drug

    Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles.

  • Venetoclax

    Drug

    Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol

  • CNS Prophylaxis

    Procedure/Surgery

    Intrathecal injection (methotrexate, cytarabine, dexamethasone) for a total of at least 15 sessions. Prophylactic cranial irradiation (18 Gy) is an alternative for patients unable or unwilling to receive intrathecal injections.

  • Hematopoietic Stem Cell Transplantation (HSCT)

    Procedure/Surgery

    Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available.

Treatment groups

43 Participants
are divided into 2 treatment groups
Group A: Chemotherapy induction ArmExperimental treatment 7 interventions
Group B: Immunotherapy induction ArmExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Event-Free Survival

Time frame
up to 5 years
2

MRD-negative CR rate by flow cytometry after induction regimen

Time frame
up to 6 weeks

Secondary outcomes

1

Complete Remission Rate

Time frame
up to 1 year
2

MRD-negative CR rate by flow cytometry at 12 weeks

Time frame
up to 12 weeks
3

MRD-negative CR rate by NGS at 12 weeks

Time frame
up to 12 weeks
4

Overall Survival (OS)

Time frame
Up to 5 years

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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