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GVHD, AcutePhase 2NCT04118075

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

A Phase 2 study testing PT-CY-FK +/-ATG in people with GVHD, Acute, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
GVHD, Acute
What is being tested?
PT-CY-FK +/-ATG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
1 Jan 2019to 1 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Rui Jin Hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

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

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
GVHD, Acute
Being tested
PT-CY-FK +/-ATG
Keywords
aGVHD, cGVHD, PT-CY
Medical subject headings
Graft vs Host Disease, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PT-CY-FK +/-ATGDrug

    Also called RJH-Lym-2018

    GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.

Study groups in NCT04118075
Study groupRoleWhat they receive
PT-CY-FK +/- ATGExperimentalGVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Receives: Drug: PT-CY-FK +/-ATG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. grade II-IV acute GVHD

    cumulated incidence of grade II-IV aGVHD

    Measured: Day 100

Secondary outcomes (8)

  1. grade III-IV acute GVHD

    cumulated incidence of grade III-IV aGVHD

    Measured: Day 100

  2. Non relapse mortality (NRM)

    cumulated incidence of NRM

    Measured: Day 100

  3. chronic GVHD (cGVHD)

    cumulated incidence of overall cGVHD

    Measured: 1 year

  4. moderate to sever chronic GVHD

    cumulated incidence of moderate to severe cGVHD

    Measured: 1 year

  5. relapse rate

    cumulated incidence of bone marrow or PET/biopsy documented relapse

    Measured: 1 year

  6. non relapse mortality

    cumulated incidence of NRM

    Measured: 1 year

  7. overall survival

    overall survival from entry of study to any cause of death

    Measured: 1 year

  8. GVHD-free relapse free survival (GRFS)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2019
  2. Study start1 Jan 2019
  3. Primary completion1 May 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04118075
Sponsor's protocol ID
RJH-Lym-2018
Status last verified
May 2021
First submitted
4 Oct 2019
Last updated
21 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PT-CY-FK +/-ATG in people with GVHD, Acute, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

grade II-IV acute GVHD (time frame: Day 100). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04118075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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