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
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMay 21, 2021
May 1, 2021
2.3 years
October 4, 2019
May 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
grade II-IV acute GVHD
cumulated incidence of grade II-IV aGVHD
Day 100
Secondary Outcomes (8)
grade III-IV acute GVHD
Day 100
Non relapse mortality (NRM)
Day 100
chronic GVHD (cGVHD)
1 year
moderate to sever chronic GVHD
1 year
relapse rate
1 year
- +3 more secondary outcomes
Study Arms (1)
PT-CY-FK +/- ATG
EXPERIMENTALGVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Interventions
GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
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.
PMID: 33816524DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiong Hu
Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Blood & Marrow Transplantation Program, Chief physician
Study Record Dates
First Submitted
October 4, 2019
First Posted
October 8, 2019
Study Start
January 1, 2019
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
May 21, 2021
Record last verified: 2021-05