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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

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
grade II-IV acute GVHD [ Time Frame: Day 100 ]
cumulated incidence of grade II-IV aGVHD
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • grade III-IV acute GVHD [ Time Frame: Day 100 ]
    cumulated incidence of grade III-IV aGVHD
  • Non relapse mortality (NRM) [ Time Frame: Day 100 ]
    cumulated incidence of NRM
  • chronic GVHD (cGVHD) [ Time Frame: 1 year ]
    cumulated incidence of overall cGVHD
  • moderate to sever chronic GVHD [ Time Frame: 1 year ]
    cumulated incidence of moderate to severe cGVHD
  • relapse rate [ Time Frame: 1 year ]
    cumulated incidence of bone marrow or PET/biopsy documented relapse
  • non relapse mortality [ Time Frame: 1 year ]
    cumulated incidence of NRM
  • overall survival [ Time Frame: 1 year ]
    overall survival from entry of study to any cause of death
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT
Official Title  ICMJE Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE GVHD, Acute
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: PT-CY-FK +/-ATG
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2020)
23
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2019)
30
Actual Study Completion Date  ICMJE May 1, 2021
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04118075
Other Study ID Numbers  ICMJE RJH-Lym-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jiong HU, Shanghai Jiao Tong University School of Medicine
Original Responsible Party Jiong HU, Shanghai Jiao Tong University School of Medicine, Head, Blood & Marrow Transplantation Center
Current Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jiong Hu Shanghai Jiao Tong University School of Medicine
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP