Efficacy and Safety of Venetoclax Combined With BEAM Pretreatment in Autologous Transplantation for DLBCL

Sponsor
Ruijin Hospital
Study ID
NCT05863845
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    100mg day -10, 200mg day -9, 400mg day -8, 800mg day -7 to -1, Given PO
  • Carmustine — DRUG
    300mg/m2 day -7, Given IV
  • Cytarabine — DRUG
    100mg/m2/d, day -6 to day -3, Given IV
  • Etoposide — DRUG
    200mg/m2/d, day -6 to day -3, Given IV
  • Melphalan — DRUG
    140mg/m2, day -2, Given IV
  • Hematopoietic Cell Transplantation — PROCEDURE
    Undergo hematopoietic cell transplantation

Study Details

This single-center, randomized clinical study will evaluate the efficacy and safety of Venetoclax combined with BEAM Pretreatment Regimen in ASCT treatment of DLBCL patients.

Key Dates

Start date
Jun 1, 2023
Status verified
May 2023
Primary completion
Nov 30, 2024
Completion
Nov 30, 2025

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: V-BEAM
    Patients in this arm will receive Venetoclax Combined With BEAM (Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT. Participants receive Venetoclax PO QD on days -10 to -1, Carmustine IV on day -7, Etoposide IV BID on days -6 to -3, Cytarabine IV BID on days -6 to -3, and Melphalan IV on day -2. Participants then undergo hematopoietic cell transplantation on day 0.
  • Sham Comparator: BEAM
    Patients in this arm will receive BEAM (Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT. Participants receive Venetoclax PO QD on days -10 to -1, Carmustine IV on day -7, Etoposide IV BID on days -6 to -3, Cytarabine IV BID on days -6 to -3, and Melphalan IV on day -2. Participants then undergo hematopoietic cell transplantation on day 0.

Primary Outcome Measure

Progression free survival [ Time Frame: Baseline up to data cut-off (up to approximately 2 years) ]

Central Contacts

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