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

NCT06525519 | Not Yet Recruiting Phase 3

• 1 other identifier: IIT2024027
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of grade II-IV acute Graft Versus Host Disease (GVHD)

  aGVHD was graded according to standard criteria

  At day 100 post-transplantation

Secondary Outcomes (3)

• Incidence of moderate to severe chronic GVHD (cGVHD)

  1 year

• Incidence of Epstein-Barr virus(EBV) viremia

  180 days

• Survival without relapse and moderate to severe GVHD

  1 year

Study Arms (2)

ATLG-20 mg/kg

EXPERIMENTAL

ATLG 20mg/kg group refers to treatment with ATLG in the total dose of 20mg/kg.

Drug: ATLG

ATLG-30mg/kg

EXPERIMENTAL

ATLG 30mg/kg group refers to treatment with ATLG in the total dose of 30mg/kg.

Drug: ATLG

Interventions

ATLG DRUG

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.

ATLG-20 mg/kg

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ，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

You may not qualify if:

• ，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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (5)

The Southwest Hospital of Amu

Chongqing, Chongqing Municipality, 400000, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

The First Bethune Hospital of Jilin University

Jilin, Jilin, 1340000, China

Location

Tai'an City Central Hospital

Taian, Shandong, 271000, China

Location

People's Liberation Army The General Hospital of Western Theater Command

Chengdu, Sichuan, 610083, China

Location

Central Study Contacts

erlie jiang

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

yigeng cao

CONTACT

18622477066; caoyigeng@ams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: July 31, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-06

Locations

CN (5)