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Completed

NCT Number: NCT04118075

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

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.

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rui Jin Hospital

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PT-CY-FK +/-ATG

Drug

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

Primary outcomes

  1. grade II-IV acute GVHD

    Time frame: Day 100

    cumulated incidence of grade II-IV aGVHD

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2019
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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