NCT05546060

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

September 15, 2022

Last Update Submit

September 15, 2022

Conditions

Hemophagocytic Lymphohistiocytosis

Keywords

Hemophagocytic LymphohistiocytosisVenetoclax

Outcome Measures

Primary Outcomes (2)

  • Overall response rate

    The percentage of cases with complete response (CR) and partial response (PR) after treatment in the total evaluable cases

    1 year

  • Incidence and severity of adverse effects

    The percentage of cases with adverse effects and its severity.

    1 years

Secondary Outcomes (1)

  • Overall survival

    1 years

Study Arms (1)

Venetoclax Combined With Dexamethasone and Etoposide

EXPERIMENTAL

Patients who met the inclusion criteria will receive venetoclax combined with dexamethasone and etoposide for 8 weeks.

Drug: VenetoclaxDrug: DexamethasoneDrug: Etoposide

Interventions

VenetoclaxDRUG

Venetoclax 100mg qd d1，200mg qd d2，400mg qd d3-56

Venetoclax Combined With Dexamethasone and Etoposide
DexamethasoneDRUG

Dexamethasone 10mg/m2 qd d1-14, 5mg/m2 qd d15-28, 2.5 mg/m2 qd d29-42, and 1.25mg/m2 qd43-56

Venetoclax Combined With Dexamethasone and Etoposide
EtoposideDRUG

Etoposide 75mg/m2 qw d1-56

Venetoclax Combined With Dexamethasone and Etoposide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18 years old, expected survival time more than 3 months;
  • met HLH-2004 diagnostic criteria；
  • ECOG score 0-2；
  • ECG QTcF interval: male ≤450ms, female ≤470ms;
  • AST and ALT ≤3.0 ULN, TB ≤1.5×ULN；serum creatinine≤1.5×ULN，or CrCL ≥ 50mL/min；INR、APTT、PT ≤1.5×ULN；
  • without pregnancy or lactation, and agree to contraception during and for at least 6 months after the study；
  • signed informed consent.

You may not qualify if:

  • patients with malignancies unrelated to HLH, except for fully recovered non-melanoma skin cancer and carcinoma in situ;
  • patients participated in other clinical trials within 4 weeks；
  • previously treated with Bcl-2 inhibitors；
  • unable to take oral medication；
  • history of substance abuse or patients with mental illness；
  • severe infection；
  • cardiovascular disease，NYHA II-IV；
  • allergic to venetoclax or etoposide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

venetoclaxDexamethasoneEtoposide

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Zhao Wang, MD

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang, MD

CONTACT

63138303wangzhao@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of hematology

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 19, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)