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

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

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.

Study Overview

• Status: Completed
• Conditions: GVHD, Acute
• Intervention / Treatment: Drug: PT-CY-FK +/-ATG

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Rui Jin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.; Other Names: RJH-Lym-2018

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
grade II-IV acute GVHD	cumulated incidence of grade II-IV aGVHD	Day 100

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
grade III-IV acute GVHD	cumulated incidence of grade III-IV aGVHD	Day 100
Non relapse mortality (NRM)	cumulated incidence of NRM	Day 100
chronic GVHD (cGVHD)	cumulated incidence of overall cGVHD	1 year
moderate to sever chronic GVHD	cumulated incidence of moderate to severe cGVHD	1 year
relapse rate	cumulated incidence of bone marrow or PET/biopsy documented relapse	1 year
non relapse mortality	cumulated incidence of NRM	1 year
overall survival	overall survival from entry of study to any cause of death	1 year
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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jiong Hu, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• Jiang JL, Gao WH, Wang LN, Wan M, Wang L, Hu J. Post-transplantation Cyclophosphamide, Tacrolimus and Low-Dose ATG as GVHD Prophylaxis for Allogeneic Peripheral Stem Cell Transplantation for Adult Patients With Lymphoid Malignancies: A Single Arm Phase II Study. Front Med (Lausanne). 2021 Mar 18;8:630160. doi: 10.3389/fmed.2021.630160. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): May 1, 2021
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: aGVHD, cGVHD, PT-CY
• Other Study ID Numbers: RJH-Lym-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No