Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05594784
Phase
PHASE2
Status
Completed

Conditions

  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olverembatinib — DRUG
    a third-generation TKI
  • Venetoclax — DRUG
    a selective inhibitor of B-cell lymphoma 2 (Bcl-2)
  • prednisone — DRUG
    Glucocorticoids
  • Vincristine — DRUG
    Anti-tumor alkaloids

Study Details

The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not available in mainland China. Olverembatinib is the only third-generation TKI drug currently approved in mainland China. Venetoclax is an oral selective inhibitor of Bcl-2, and small exploratory clinical studies have demonstrated that venetoclax in combination with ponatinib showed high rates of CR as well as molecular response in relapsed/refractory Ph+ ALL. This study will explore the safety and efficacy of olverembatinib in combination with reduced-intensity chemotherapy and venetoclax in patients with newly diagnosed Ph+ ALL.

Key Dates

Start date
Oct 8, 2022
Status verified
May 2024
Primary completion
Mar 25, 2025
Completion
Mar 25, 2025

Study Design

Enrollment
79 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax
    For Induction cycle, olverembatinib will be given orally 40mg every other day. Patients with CMR, olverembatinib will be reduced to 30 mg every other day. Induction and consolidation cycles combined with a certain period of venetoclax. Reduced-intensity chemotherapy regimens consist mainly of vincristine and prednisone. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients who keep BCR/ABL negative can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation chemotherapy.

Primary Outcome Measure

CMR rate [ Time Frame: At 3 months of treatment (90 days) ]

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