Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in HLH

Sponsor
Beijing Friendship Hospital
Study ID
NCT05546060
Phase
PHASE1
Status
Unknown

Conditions

  • Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Venetoclax 100mg qd d1，200mg qd d2，400mg qd d3-56
  • Dexamethasone — DRUG
    Dexamethasone 10mg/m2 qd d1-14, 5mg/m2 qd d15-28, 2.5 mg/m2 qd d29-42, and 1.25mg/m2 qd43-56
  • Etoposide — DRUG
    Etoposide 75mg/m2 qw d1-56

Study Details

This study aimed to investigate the efficacy and safety of venetoclax combined with dexamethasone and etoposide as a salvage therapy for hemophagocytic lymphohistiocytosis.

Key Dates

Start date
Jul 1, 2022
Status verified
Sep 2022
Primary completion
Jul 1, 2025
Completion
Oct 1, 2025

Study Design

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

Arms

  • Experimental: Venetoclax Combined With Dexamethasone and Etoposide
    Patients who met the inclusion criteria will receive venetoclax combined with dexamethasone and etoposide for 8 weeks.

Primary Outcome Measure

Overall response rate [ Time Frame: 1 year ]

Central Contacts

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