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Lymphoma, Large B-Cell, DiffusePhase 2NCT03629873

Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects

A Phase 2 study testing Chidamide in people with Lymphoma, Large B-Cell, Diffuse and Mantle Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Chidamide
How many people
69 participants
Where
1 siteChina
Study dates
1 Feb 2018to 31 Dec 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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry, aaIPI≥2 or double-hit lymphoma, as first-line consolidation; diffuse large B cell lymphoma as second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy.
  • Adequate organ system function including:
  • Creatinine clearance rate ≥ 80ml/min and creatinine < 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin < 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia
  • Age 18-60 years, male and female
  • ECOG score 0-1
  • Number of neutrophil ≥ 1.5×10^9/L, number of platelet ≥ 70×10^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10^6/kg
  • Expected survival ≥ 12 weeks
  • Volunteered to participate in this study and signed informed consent

Who cannot join

  • Have evidence of CNS lymphoma
  • Relapse after autologous hematopoietic stem cell transplantation
  • Active hepatitis B or hepatitis C virus infection
  • Severe active infection
  • HIV-infected persons
  • Liver cirrhosis or hepatic fibrosis
Show all 11Show fewer
  • QTc > 500ms
  • Have mental disorder or unable to sign informed consent
  • History of drug abuse and intemperance
  • Women who are pregnant or lactating or have breeding intent
  • The investigators believe that any increase in the risk of the subject or interference with the results of the trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hematological Department, People's Hospital of Jiangsu Province

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects

This is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects

Being tested
Chidamide
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, T-Cell, Peripheral

What participants receive

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

  • ChidamideDrug

    Also called Carmustine, Etoposide, Cytarabine, Cyclophosphamide

    Chidamide 30mg po d-7、-4、0、3; Carmustine 300mg/m^2 IVD d-6; Etoposide 150mg/m^2/d qd IVD d-5~-2; Cytarabine 150mg/m^2 q12h IVD d-5~-2; Cyclophosphamide 1.0g/m^2/d qd IVD d-5~-2

What is being measured

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

  1. Progression-free survival rate

    Measured: 2 years after transplantation

Secondary outcomes (4)

  1. Overall survival

    Measured: 2 years after transplantation

  2. Complete remission

    Measured: 3 months after transplantation

  3. Time of hematopoietic reconstitution

    Measured: 15 days, 1 month

  4. Non-relapse mortality

    Measured: 2 years

Timeline

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

  1. First posted14 Aug 2018
  2. Study start1 Feb 2018
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03629873
Sponsor's protocol ID
JSPH-Chi-BEAC-HSCT
Status last verified
Dec 2021
First submitted
5 Aug 2018
Last updated
3 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide in people with Lymphoma, Large B-Cell, Diffuse and Mantle Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 8 inclusion and 11 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 3 Jan 2022. 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?

Results are not available in the source record.

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?

Progression-free survival rate (time frame: 2 years after transplantation). 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 NCT03629873.

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 3 Jan 2022.

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