CompletedNCT04118075Updated May 21, 2021

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

A Phase 2 interventional study of PT-CY-FK +/-ATG in GVHD, Acute, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Prevention

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Jan 2019, registered Oct 2019).

Phase: Phase 2
Study type: Interventional
Enrollment: 23
Allocation: Not applicable
Ages: 16 Years to 60 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

GVHD, Acute

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Keywords

aGVHD, cGVHD, PT-CY

In context

Graft vs Host Disease

815 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 23 is below the median of 35 across 643 interventional studies indexed under Graft vs Host Disease.

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Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 370 studies on the registry; 107 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 23 participants (actual)

Study arms

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

Interventions

DrugPT-CY-FK +/-ATG
GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Also known as: RJH-Lym-2018

What researchers measure

Primary outcomes

grade II-IV acute GVHD
cumulated incidence of grade II-IV aGVHD
Time frame: Day 100

Secondary outcomes

grade III-IV acute GVHD
cumulated incidence of grade III-IV aGVHD
Time frame: Day 100
Non relapse mortality (NRM)
cumulated incidence of NRM
Time frame: Day 100
chronic GVHD (cGVHD)
cumulated incidence of overall cGVHD
Time frame: 1 year
moderate to sever chronic GVHD
cumulated incidence of moderate to severe cGVHD
Time frame: 1 year
relapse rate
cumulated incidence of bone marrow or PET/biopsy documented relapse
Time frame: 1 year
non relapse mortality
cumulated incidence of NRM
Time frame: 1 year
overall survival
overall survival from entry of study to any cause of death
Time frame: 1 year
GVHD-free relapse free survival (GRFS)
survival without II-IV aGVHD, moderate to severe cGVHD, relapse or any other death event of any case
Time frame: 1 year

Study locations

1 site

Rui Jin Hospital
Shanghai, Shanghai Municipality 200025, China

References and documents

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. PubMed 33816524 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in May 2021, 28 months.

Of 93 non-industry phase 2 interventional studies under Graft vs Host Disease, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 86. This study's 28 months is below that.

Counting every sponsor, half of 112 studies reached it within 49 months; a quarter within 27 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 4, 2019
First posted: Oct 8, 2019
StartActual: Jan 1, 2019
Primary completionActual: May 1, 2021
CompletionActual: May 1, 2021
Last update: May 21, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04118075
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Responsible party: Jiong HU (Head, Blood & Marrow Transplantation Program, Chief physician, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted: Oct 8, 2019
Start date: Jan 1, 2019
Primary completion: May 1, 2021
Completion: May 1, 2021
Last update: May 21, 2021

Study contacts

Jiong Hu

principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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