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

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04118075
Collaborator
(none)
23
Enrollment
1
Location
1
Arm
28
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Jan 1, 2019
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. grade II-IV acute GVHD [Day 100]

      cumulated incidence of grade II-IV aGVHD

    Secondary Outcome Measures

    1. grade III-IV acute GVHD [Day 100]

      cumulated incidence of grade III-IV aGVHD

    2. Non relapse mortality (NRM) [Day 100]

      cumulated incidence of NRM

    3. chronic GVHD (cGVHD) [1 year]

      cumulated incidence of overall cGVHD

    4. moderate to sever chronic GVHD [1 year]

      cumulated incidence of moderate to severe cGVHD

    5. relapse rate [1 year]

      cumulated incidence of bone marrow or PET/biopsy documented relapse

    6. non relapse mortality [1 year]

      cumulated incidence of NRM

    7. overall survival [1 year]

      overall survival from entry of study to any cause of death

    8. GVHD-free relapse free survival (GRFS) [1 year]

      survival without II-IV aGVHD, moderate to severe cGVHD, relapse or any other death event of any case

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Rui Jin Hospital Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 8, 2019
    Last Update Posted:
    May 21, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jiong HU, Head, Blood & Marrow Transplantation Program, Chief physician, Shanghai Jiao Tong University School of Medicine
    aGVHD, cGVHD, PT-CY

    Study Results

    No Results Posted as of May 21, 2021