Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT06686108
Phase
PHASE2
Status
Recruiting
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Conditions

  • ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
  • Relapse
  • T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
14 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine (AZA) Days 1 - 5 — DRUG
    Azacitidine, ih, 32mg/m2/d, days 1-5 of each 28-day cycle
  • Decitabine (DAC) — DRUG
    decitabine, 5mg/m2/d, days 1-5 of each 28-day cycle.
  • Venetoclax — DRUG
    venetoclax, 400mg/d, days 1-7 of each 28-day cycle

Study Details

This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.

Key Dates

Start date
Oct 30, 2024
Status verified
Oct 2024
Primary completion
Oct 30, 2027
Completion
Oct 30, 2028

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: combination therapy
    There is only 1 arm. Combination therapy arm included venetoclax combined with hypomethylating agents such as azacitidine or decitabine. 1. venetoclax: 400mg/d, po, days 1-7 of each 28-day cycle. 2.For patients without TP53 mutation, azacitidine was administered: 32mg/m2/d, ih, days 1-5 of each 28-day cycle; for patients with TP53 mutation, decitabine was administered: 5mg/m2/d, iv, days 1-5 of each 28-day cycle.

Primary Outcome Measure

RFS [ Time Frame: 1 year ]

Central Contacts

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