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Peripheral T Cell LymphomaNCT06509945

Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL

A study testing allogeneic peripheral blood stem cell transplantation in people with Peripheral T Cell Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation in the treatment of high-risk peripheral T-cells lymphoma patients achieved complete response (CR) or partial response (PR). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Peripheral T Cell Lymphoma
What is being tested?
allogeneic peripheral blood stem cell transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
15 Jul 2024to 15 Jul 2026
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age between 18 and less than 70 years, regardless of gender 2. Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria:
  • High risk: IPI（International Prognostic Index） score ≥ 3 or aaIPI（age-adjusted International Prognostic Index） score ≥ 2 ( aaIPI is suitable for patients younger than 60 years old).
  • Patients who achieved complete response (CR) or partial response (PR) after first-line chemotherapy (PET-CT or CT examination was performed according to the patient 's economic conditions） 3.Patients must have a suitable hematopoietic stem cell donor:
  • Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
  • Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and -DRB1.
  • 4.Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2. 5.ECOG (Eastern Cooperative Oncology Group) performance status: 0-2. 6.Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
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  • Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
  • Cardiac function: Ejection fraction ≥ 50%.
  • Baseline oxygen saturation > 92%.
  • Total bilirubin ≤ 2.0 x ULN; ALT and AST ≤ 2.0 x ULN，AKP ≤ 2.0 x ULN
  • Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
  • 7.Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.

Who cannot join

  • PTCL patients did not meet the criteria of high-risk.
  • PTCL ALK + patients with CR after first-line treatment.
  • History of malignancies other than lymphoid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively treated localized prostate cancer or ductal carcinoma in situ
  • ECOG ≥ 3.
  • HCT-CI score ≥ 3.
  • Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association [NYHA] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.
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  • Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection.
  • HIV-infected individuals.
  • Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.
  • History of autoimmune diseases
  • Pregnant or breastfeeding women.
  • Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.

Trial locations and contacts

1 site in 1 country.

xianmin song, MD contact

+862163240090

shongxm@139.com

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    xianmin Song, MD, 86-21-63240090 ext. 3172, shongxm@sjtu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Allogeneic Peripheral Blood Stem Cell Transplantation as the First-line Treatment for Patients With the High-risk Peripheral T Cell Lymphoma

This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation in the treatment of high-risk peripheral T-cells lymphoma patients achieved complete response (CR) or partial response (PR). Conventional conditioning regimen is adopted while the reduced-intensity conditioning regimens will be preferred. Donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro-D-glucose integrated with computed tomography (18F-FDG PET/CT) imaging will be performed every 6 months after transplantation. If disease relapse is suspected during the follow-up period, bone marrow and relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.

Being tested
allogeneic peripheral blood stem cell transplantation
Keywords
peripheral T cell lymphoma, allogeneic peripheral blood stem cell transplantation, high-risk
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

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

  • allogeneic peripheral blood stem cell transplantationOther

    Patients achieved response to treatment will receive allogeneic peripheral blood stem cell transplantation.

Study groups in NCT06509945
Study groupRoleWhat they receive
intervention armExperimentalParticipants will receive allogeneic peripheral blood stem cell transplantation.
Receives: Other: allogeneic peripheral blood stem cell transplantation

What is being measured

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

  1. 1y and 2y-progression-free survival (PFS)

    1-year and 2-year progression-free survival (PFS) rates post-transplant

    Measured: up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS

Secondary outcomes (7)

  1. acute graft-versus-host disease (aGVHD)

    acute graft-versus-host disease (aGVHD) within 180 days post-transplant

    Measured: up to 180 days

  2. 1y and 2y-cumulative relapse rates (CIR)

    cumulative relapse rates (CIR) at 1 year and 2 years post-transplant

    Measured: up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR

  3. 1y and 2y-overall survival (OS)

    overall survival (OS) at 1 year and 2 years post-transplant

    Measured: up to 1 years for the 1y-OS and up to 2 years for the 2y-OS

  4. graft-versus-host disease-free and relapse-free survival (GRFS)

    graft-versus-host disease-free and relapse-free survival (GRFS) at 2 years post-transplant

    Measured: up to 2 years

  5. non-relapse mortality (NRM)

    non-relapse mortality (NRM) at 2 years post-transplant

    Measured: up to 2 years

  6. cumulative incidence of chronic graft-versus-host disease (cGVHD)

    cumulative incidence of chronic graft-versus-host disease (cGVHD) at 2 years post-transplant

    Measured: up to 2 years

  7. Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation

    the incidence of CMV and EBV reactivation within 1 year

    Measured: up to 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 posted19 Jul 2024
  2. Study start15 Jul 2024
  3. Primary completion15 Jul 2026 (estimated)
  4. Study completion15 Jul 2026 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509945
Sponsor's protocol ID
SHSYXY-202404-PTCL
Status last verified
Jul 2024
First submitted
15 Jul 2024
Last updated
1 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cao C, Feng J, Gu H, Tang H, Xu L, Dong H, Dong B, Shu M, Bai Q, Liang R, Zhang T, Yang L, Wang Z, Chen X, Gao G. Distribution of lymphoid neoplasms in Northwest China: Analysis of 3244 cases according to WHO classification in a single institution. Ann Diagn Pathol. 2018 Jun;34:60-65. doi: 10.1016/j.anndiagpath.2017.05.005. Epub 2017 May 12.

    PubMed 29661730

  • Yang QP, Zhang WY, Yu JB, Zhao S, Xu H, Wang WY, Bi CF, Zuo Z, Wang XQ, Huang J, Dai L, Liu WP. Subtype distribution of lymphomas in Southwest China: analysis of 6,382 cases using WHO classification in a single institution. Diagn Pathol. 2011 Aug 22;6:77. doi: 10.1186/1746-1596-6-77.

    PubMed 21854649

Questions about this trial

What is this clinical trial studying?

A study testing allogeneic peripheral blood stem cell transplantation in people with Peripheral T Cell Lymphoma, run by Shanghai General Hospital, 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 12 inclusion and 12 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 1 Aug 2024. 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.

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 xianmin song, MD (+862163240090, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1y and 2y-progression-free survival (PFS) (time frame: up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS). 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 NCT06509945, which also lists 2 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 1 Aug 2024.

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