Comparison of Different Dose of Anti-T Lymphocyte Globulin (ATLG) in Haploidentical HSCT for GVHD Prophylaxis

July 24, 2024 updated by: Institute of Hematology & Blood Diseases Hospital, China

Dose Study of Anti-T Lymphocyte Globulin (ATLG) in GVHD Prophylaxis

This study aims to compare the incidence of graft-versus-host disease (GVHD) in haploidentical hematopoietic stem cell transplant recipients who receive varying doses of anti-T lymphocyte globulin (ATLG) for GVHD prophylaxis. Our primary objective is to determine the optimal dose of ATLG for preventing acute GVHD (aGVHD). Additionally, we plan to evaluate the impact of different doses of ATLG on post-transplant viral infections and other clinical outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only therapeutic option for many hematological malignancies. Haploidentical related donor transplantation is now considered an important allo-HSCT. GVHD prevention has a crucial role in post-transplant outcomes by potentially interfering with the graft-versus-leukemia (GVL) effect and immune reconstitution. In vivo T cell depletion (TCD) modalities, including anti-T lymphocyte globulin (ATLG)-based protocols have been widely used worldwide for GVHD prophylaxis.

Several European studies have shown that a dose of 30mg/kg of ATLG can effectively prevent GVHD with acceptable safety. But, the most commonly reported dose among Chinese population is 20mg/kg. Additionally, the main type of allo-HSCT in China is haploidentical transplantation. The application experience of ATLG in Europe mainly focuses on sibling and unrelated donor transplants. There is still a lack of sufficient exploration on the optimal dose of ATLG in GVHD prevention in haploidentical transplantation.

In this prospective multiple-center randomized trial, we aim to compare the effects of different doses of ATLG on GVHD prevention, risk of viral infection, and patient survival after haploidentical transplantation.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
        • Contact:
        • Contact:
    • Jilin
      • Jilin, Jilin, China, 1340000
    • Shandong
      • Taian, Shandong, China, 271000
    • Sichuan
      • Chengdu, Sichuan, China, 610083
        • People's Liberation Army The General Hospital of Western Theater Command
        • Contact:
        • Contact:

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，Age ≥ 16 and ≤ 65 years 2, Patients undergoing Haplo-identical hematopoietic stem cell transplantation 3, AML and ALL in complete cytologic response or MDS requiring allogeneic stem cell transplantation 4, ECOG performance status ≤ 2

Exclusion Criteria:

  • 1，Pregnant or lactating females 2，Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation 3, Patients with major organ abnormal including renal, liver, lung , heart and/or CNS diseases, where these diseases or others cannot be controlled by treatment and may affect the completion of this study 4, Uncontrolled infection 5, Seropositivity for HIV or HTLV-1 or active hepatitis B or C 6, Patients with any other complications that may affect this study or with a history of malignant diseases.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATLG-20 mg/kg
ATLG 20mg/kg group refers to treatment with ATLG in the total dose of 20mg/kg.
Drug: ATLG
5 mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
Drug: ATLG
7.5mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
Experimental: ATLG-30mg/kg
ATLG 30mg/kg group refers to treatment with ATLG in the total dose of 30mg/kg.
Drug: ATLG
5 mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
Drug: ATLG
7.5mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade II-IV acute Graft Versus Host Disease (GVHD)
Time Frame: At day 100 post-transplantation
aGVHD was graded according to standard criteria
At day 100 post-transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival without relapse and moderate to severe GVHD
Time Frame: 1 year
Rate of patients remain alive without disease relapse or progression (bone marrow blast >5% or extra medullary diseases) and without documentation of grade III-IV acute GVHD and moderate to severe chronic GVHD
1 year
Incidence of moderate to severe chronic GVHD (cGVHD)
Time Frame: 1 year
Chronic GVHD was assessed in patients alive after day 100. cGVHD was graded according to standard criteria.
1 year
Incidence of Epstein-Barr virus(EBV) viremia
Time Frame: 180 days
Incidence of EBV viremia within 180 days
180 days

Collaborators and Investigators

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

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)

July 31, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IIT2024027

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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