GTP Regimen in the Treatment of Refractory/Recurrent HLH

September 8, 2023 updated by: Zhao Wang, Beijing Friendship Hospital

Clinical Study on Efficacy and Safety of GTP Regimen in the Treatment of Refractory/Recurrent Hemophagocytic Lymphohistiocytosis

The goal of this clinical trial is to learn about efficacy and safety of GTP regimen in refractory/recurrent hemophagocytic lymphohistiocytosis. The main questions it aims to answer are:

  • Overall remission rate of GTP regimen in R/R HLH
  • Adverse effect of GTP regimen Participants will be treated with GTP regimen

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Refractory/recurrent hemophagocytic lymphohistiocytosis will be treated with emapalumab combined with teniposide and methylprednisolone. Observed the overall response rate and side effects.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female patients ≥1 month of age with HLH
  2. Definitive diagnosis of HLH: meets the molecular diagnosis of pHLH or has a family history of HLH, or meets at least 5 of the 8 diagnostic criteria of HLH-2004.

  3. The investigators assessed the presence of refractory/recurrent HLH disease. Patients must meet one of the following criteria assessed by the investigator:

    • Previous conventional HLH treatment did not respond.
    • The patients were not satisfied with the efficacy of conventional HLH treatment or their condition worsened.
    • HLH reactivation occurs. Reactivation is defined as: worsening of two or more HLH clinical and laboratory criteria (after initial remission).
  4. According to the researchers, the expected survival was more than 2 weeks.
  5. The informed consent is signed by the patient or his legal guardian (patients under 18 years), or by the patient's legally authorized representative.
  6. Women who are fertile are willing to use a highly effective contraceptive method from the start of the study until 6 months after the end of the last course of treatment.

Exclusion Criteria:

  1. There is active mycobacterium, histoplasma capsulatus, Salmonella, or leishmania infection.
  2. There is uncontrolled active gastrointestinal bleeding.
  3. The investigator believes that there are any serious comorbidities or any other conditions that make the patient unsuitable for treatment.
  4. A history of hypersensitivity or hypersensitivity to any component of the drug in the study protocol, such as polysorbate.
  5. Had received the BCG vaccine within 12 weeks prior to screening.
  6. Have received live or attenuated vaccine (except BCG) within 4 weeks prior to screening.
  7. Pregnancy patients.
  8. Within 4 weeks prior to enrollment in this study, another concurrent clinical intervention study was enrolled.
  9. There is any condition or circumstance that the investigator believes may cause the patient to be unable to complete the study or to comply with study procedures or requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GTP regimen treated patients
R/R HLH patients treated with GTP regimen
Drug: GTP regimen
Refractory/recurrent hemophagocytic lymphohistiocytosis patients will be treated with GTP regimen (Emapalumab+Teniposide+Methylprednisolone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 1 year
Overall remission rate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2023

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFH20230717001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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