PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT

GVHD, Acute Clinical Trial

Official title:

Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118075
• Other study ID #: RJH-Lym-2018
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All patients received Flu-BU-VP16 as myeloablative conditioning followed by cyclophosphamide (D+3 and +4) and subsequent tacrolimus. For patients with unrelated or haplo-donor received low-dose ATG at Day +15.

Description:

For patients with high-risk lymphoid malignancies, patients will undergo allo-HSCT from HLA matched sibling, unrelated (9~10/10) donor or hallo-identical donors. For all patients will receive myeloablative conditioning with 5-day fludarabine, 2-day VP-16 and 3-day busulifan. For prophylaxis graft versus host disease (GVHD), patients will receive cyclophosphamide 50mg/kg daily on D+3 and +4 with subsequent tacrolimus starting at D+5. For patients receiving HSCT from unrelated or haplo-donor, low-dose ATG 2.5mg/kg will be given on Day +15.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with lymphoid malignancies: CR1 or CR2 for acute lymphoblastic leukemia; T cell lymphoma (any CR/PR); B cell lymphoma (PR1 or CR2), hodgkin's disease (CR2 or beyond), Sezary syndrome
• patients with HLA matched sibling, unrelated (HLA 9~10/10 matched) or haplo-identical donor

Exclusion Criteria:

• patients with active infection
• patients with abnormal liver function damage: ALT/AST above 2X normal range
• patients with abnormal renal function damage Scr>160µmol/L;
• patients with insufficient pulmonary function (FEV1,FVC,DLCO<50%)and heart failure or with EF <50%)
• patients with mental instability
• unwilling to give inform consent

Related Conditions & MeSH terms

• GVHD, Acute

Intervention

Drug:
• PT-CY-FK +/-ATG
GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.

Locations

Country	Name	City	State
China	Rui Jin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grade II-IV acute GVHD	cumulated incidence of grade II-IV aGVHD	Day 100
Secondary	grade III-IV acute GVHD	cumulated incidence of grade III-IV aGVHD	Day 100
Secondary	Non relapse mortality (NRM)	cumulated incidence of NRM	Day 100
Secondary	chronic GVHD (cGVHD)	cumulated incidence of overall cGVHD	1 year
Secondary	moderate to sever chronic GVHD	cumulated incidence of moderate to severe cGVHD	1 year
Secondary	relapse rate	cumulated incidence of bone marrow or PET/biopsy documented relapse	1 year
Secondary	non relapse mortality	cumulated incidence of NRM	1 year
Secondary	overall survival	overall survival from entry of study to any cause of death	1 year
Secondary	GVHD-free relapse free survival (GRFS)	survival without II-IV aGVHD, moderate to severe cGVHD, relapse or any other death event of any case	1 year