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Hematopoietic Stem Cell TransplantationPhase 4NCT03689465

PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

A Phase 4 study testing ATG, CTX and Mycophenolate Mofetil in people with Hematopoietic Stem Cell Transplantation, run by Nanfang Hospital, Southern Medical University at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hematopoietic Stem Cell Transplantation
What is being tested?
ATG, CTX and Mycophenolate Mofetil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
7 sitesChina
Study dates
29 Oct 2018to 31 Dec 2020
Phase
Phase 4
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient age of 18-65 years
  • Haploidentical hematopoietic stem cell transplant recipient
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Who cannot join

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

Trial locations and contacts

7 sites in 1 country.

Ren Lin, M.D. contact

+86-020-62787883

lansinglinren@hotmail.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Peking University People's Hospital

    Beijing

    Wang Yu

    Xiaojun Huang

    Not yet recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan

    Yajing Xu

    Yajing Xu

    Not yet recruiting

  • Chenzhou First People's Hospital

    Chenzhou, Hunan

    Xinquan Liang

    Xinquan Liang

    Not yet recruiting

  • Department of Hematology,Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Ren Lin, MD, +86-020-61641613, lansinglinren@hotmail.com

    Qifa Liu

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

    Shunqing Wang

    Shunqing Wang

    Not yet recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Danian Nie

    Danian Nie

    Not yet recruiting

  • The Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong

    Dongjun Lin

    Dongjun Lin

    Not yet recruiting

Other trials in China

About this study

Official title: A Comparison of PTCy-ATG and ATG Strategy in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.

Read the detailed description

Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, the strategies for graft-versus-host disease (GVHD) prophylaxis mainly include ex vivo and in vivo T-cell depletion (TCD) in haploidentical HSCT (haplo-HSCT). In vivo TCD modalities have become mainstream including granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols. The ATG strategy has been widely used. Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. In addition, infections, especially viral infections, remain an important drawback of this strategy. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.

Being tested
ATG, CTX, Mycophenolate Mofetil, Ciclosporin A (CsA), methotrexate (MTX)
Keywords
Hematopoietic Stem Cell Transplantation, posttransplantation cyclophosphamide, antithymocyte globulin, viral infection, graft-versus-host disease
Medical subject headings
Virus Diseases, Graft vs Host Disease

What participants receive

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

  • ATGDrug

    In PTCy-ATG group, ATG will be intravenously infused via a central venous catheter from day -3 until day -1 at a total dose of 4.5mg/kg. In ATG group, ATG will be intravenously infused via a central venous catheter from day -5 until day -2 at a total dose of 7.5mg/kg.

  • CTXDrug

    In PTCy-ATG group, CTX will be intravenously infused via a central venous catheter on day +4 at a dose of 50mg/kg/d.

  • Mycophenolate MofetilDrug

    In PTCy-ATG group, Mycophenolate Mofetil will be taken orally from day +5 with the dosage of 0.5g twice a day. The dosage will be halved from day +30. In ATG group, Mycophenolate Mofetil will be taken orally from day -9 with the dosage of 0.5g twice a day. The dosage will be halved from day +30.

  • Ciclosporin A (CsA)Drug

    In PTCy-ATG group, Ciclosporin A (CsA) will be intravenously infused from day +5 at a dose of 2.5mg/kg/d. In ATG group, Ciclosporin A (CsA) will be intravenously infused from day -9 at a dose of 2.5mg/kg/d.

  • methotrexate (MTX)Drug

    In ATG group, methotrexate (MTX) will be intravenously on days +1, +3 and +6.

Study groups in NCT03689465
Study groupRoleWhat they receive
PTCy-ATG groupActive comparatorPTCy-ATG group refers to treatment with PTCy-ATG protocol as GVHD prophylaxis at a total dose of 4.5mg/kg ATG, a dose of 50mg/kg/d cyclophosphamide (CTX), a dose of 2.5mg/kg/d Ciclosporin A （CsA）, and a dose of 1.0g/d Mycophenolate Mofetil(MMF).
Receives: Drug: ATG; Drug: CTX; Drug: Mycophenolate Mofetil; Drug: Ciclosporin A (CsA)
ATG groupActive comparatorATG group refers to treatment with ATG protocol as GVHD prophylaxis at a total dose of 7.5mg/kg ATG, a dose of 2.5mg/kg/d Ciclosporin A （CsA）, a dose of 1.0g/d Mycophenolate Mofetil(MMF) and methotrexate (MTX, on days +1, +3 and +6).
Receives: Drug: ATG; Drug: Mycophenolate Mofetil; Drug: Ciclosporin A (CsA); Drug: methotrexate (MTX)

What is being measured

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

  1. CMV DNAemia

    CMV DNAemia was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml.

    Measured: 1 year posttransplantation

Secondary outcomes (6)

  1. aGVHD

    aGVHD (acute GVHD) was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.

    Measured: 100 days 1 year posttransplantation

  2. cGVHD

    Chronic GVHD (cGVHD) was graded as limited or extensive.

    Measured: 2 year posttransplantation

  3. EBV DNAemia

    EBV DNAemia was defined as positive EBV-DNA in the blood when the copies exceeded 500 copies/ml.

    Measured: 1 year posttransplantation

  4. Leukemia relapse

    primary disease relapse

    Measured: 2 year posttransplantation

  5. OS

    overall survival

    Measured: 2 year posttransplantation

  6. DFS

    disease-free survival

    Measured: 2 year posttransplantation

Timeline

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

  1. First posted28 Sep 2018
  2. Study start29 Oct 2018
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03689465
Sponsor's protocol ID
PTCy-ATG-2018
Status last verified
Sep 2019
First submitted
13 Aug 2018
Last updated
28 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang Y, Fu HX, Liu DH, Xu LP, Zhang XH, Chang YJ, Chen YH, Wang FR, Sun YQ, Tang FF, Liu KY, Huang XJ. Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: a randomized trial. Bone Marrow Transplant. 2014 Mar;49(3):426-33. doi: 10.1038/bmt.2013.191. Epub 2013 Dec 2.

    PubMed 24292519

  • Chang YJ, Huang XJ. Haploidentical SCT: the mechanisms underlying the crossing of HLA barriers. Bone Marrow Transplant. 2014 Jul;49(7):873-9. doi: 10.1038/bmt.2014.19. Epub 2014 Feb 24.

    PubMed 24566712

  • Baron F, Mohty M, Blaise D, Socie G, Labopin M, Esteve J, Ciceri F, Giebel S, Gorin NC, Savani BN, Schmid C, Nagler A. Anti-thymocyte globulin as graft-versus-host disease prevention in the setting of allogeneic peripheral blood stem cell transplantation: a review from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation. Haematologica. 2017 Feb;102(2):224-234. doi: 10.3324/haematol.2016.148510. Epub 2016 Dec 7.

    PubMed 27927772

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ATG, CTX and Mycophenolate Mofetil in people with Hematopoietic Stem Cell Transplantation, run by Nanfang Hospital, Southern Medical University at 7 sites 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Ren Lin, M.D. (+86-020-62787883, lansinglinren@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CMV DNAemia (time frame: 1 year posttransplantation). 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 NCT03689465, which also lists 3 linked publications.

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 28 Oct 2019.

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