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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118075
Recruitment Status : Completed
First Posted : October 8, 2019
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
GVHD, Acute Drug: PT-CY-FK +/-ATG Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : May 1, 2021
Actual Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: RJH-Lym-2018


Outcome Measures
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Primary Outcome Measures :
  1. grade II-IV acute GVHD [ Time Frame: Day 100 ]
    cumulated incidence of grade II-IV aGVHD


Secondary Outcome Measures :
  1. grade III-IV acute GVHD [ Time Frame: Day 100 ]
    cumulated incidence of grade III-IV aGVHD

  2. Non relapse mortality (NRM) [ Time Frame: Day 100 ]
    cumulated incidence of NRM

  3. chronic GVHD (cGVHD) [ Time Frame: 1 year ]
    cumulated incidence of overall cGVHD

  4. moderate to sever chronic GVHD [ Time Frame: 1 year ]
    cumulated incidence of moderate to severe cGVHD

  5. relapse rate [ Time Frame: 1 year ]
    cumulated incidence of bone marrow or PET/biopsy documented relapse

  6. non relapse mortality [ Time Frame: 1 year ]
    cumulated incidence of NRM

  7. overall survival [ Time Frame: 1 year ]
    overall survival from entry of study to any cause of death

  8. GVHD-free relapse free survival (GRFS) [ Time Frame: 1 year ]
    survival without II-IV aGVHD, moderate to severe cGVHD, relapse or any other death event of any case


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118075


Locations
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China, Shanghai
Rui Jin Hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Jiong Hu Shanghai Jiao Tong University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiong HU, Head, Blood & Marrow Transplantation Program, Chief physician, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04118075    
Other Study ID Numbers: RJH-Lym-2018
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:
aGVHD, cGVHD, PT-CY