VHAG in Treating R/R T-ALL/LBL

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06742463
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute T Lymphpblastic Leukemia/Lymphoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    BCL-2 inhibitor
  • homoharringtonine — DRUG
    alkaloid
  • Cytarabine (Ara-C) — DRUG
    Metabolic antagonist.
  • G-CSF — DRUG
    Granulocyte colony-stimulating factor

Study Details

Acute T cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) is an aggressive type of leukemia that results from the malignant evolution of T-lineage progenitor cells at different differentiation stages. After induction chemotherapy and consolidation chemotherapy, there are still about 30% of patients who cannot achieve complete remission of clinical symptoms or negative MRD. This is also an important factor for the recurrence of ALL patients. In addition, most relapsed T-ALL/LBL patients relapse during first-line treatment. Once the disease relapses, it is difficult to cure for most young and adult patients, and the overall survival rate of patients is less than 10%.

Key Dates

Start date
Dec 31, 2024
Status verified
Oct 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.

Primary Outcome Measure

Complete remission with or without incomplete PB cell recovery(CR/CRi) rate [ Time Frame: at the end of Cycle 1 and 2（each cycle is 28days） ]

Central Contacts