Skip to main content
OpenTrials
Completed

NCT Number: NCT02677181

Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

The purpose of this study is to determine the efficacy and safety of combined ATG (antithymocyte globulin ) regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liping Dou

Beijing, Beijing Municipality, 100853, China

About this study

Transplantation with G-CSF (Granulocyte colony stimulating factor )mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long-term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute myeloid leukemia (AML) in CR1 (complete remission 1) or CR2 (complete remission 2) phase regardless of cytogenetics;
  • CML CP(chronic myelogenous leukemia , chronic phase); NHL (non-Hodgkin's lymphoma )
  • MDS-RAEB(myelodysplastic syndrome -refractory anemia with excess blasts ).
  • All patients should aged 40 to 70 years
  • Have matched sibling donor.
  • Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases .

Exclusion criteria

  • Patients aged less than 40 years old ;
  • Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases;
  • AML patients with t (15;17);

Treatment and study plan

ATG

Drug

rabbit ATG(Sanofi)

Other names: Thymoglobuline

CsA

Drug

cyclosporine (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered.

Other names: Neoral/Sandimmun

Mycophenolate mofetil

Drug

From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.

Other names: MMF(Novartis)

methotrexate

Drug

short-term methotrexate

Other names: MTX(Pfizer)

Primary outcomes

  1. Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)

    Time frame: three years

    Chronic graft versus host disease grading criteria (refer to NIH criteria)

Secondary outcomes

  1. all cause mortality

    Time frame: two years

  2. Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria

    Time frame: two years

  3. DFS(disease-free survival )

    Time frame: two years

    disease-free survival

  4. TRM(treatment-related mortality )

    Time frame: two years

    treatment-related mortality

  5. Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • 309th Hospital of Chinese People's Liberation Army
  • Beijing Naval General Hospital
  • Space Center Hospital, Peking University

Registry information

Official study title

Prospective Study of Combined ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Feb 9, 2016
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.