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Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07493486

IT-TT as an Effective and Well-Tolerated Strategy for CNS Prop in High-Risk DLBCL: a Prospective Ph II Study

A Phase 2 study testing (RCHOP or an investigator's choice) plus IT thiotepa and dexamethasone in people with Diffuse Large B-Cell Lymphoma (DLBCL) and Intrathecal Chemotherapy, run by Zhejiang Cancer Hospital 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

This is a prospective, single-arm clinical study to evaluate the efficacy and safety of intrathecal thiotepa for the prevention of central nervous system (CNS) involvement in patients with high-aggressive B-cell lymphoma. A total of 32 subjects will be enrolled, and the study is planned to last for 2 years. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
(RCHOP or an investigator's choice) plus IT thiotepa and dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
1 Feb 2022to 31 Aug 2023
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in the clinical study: full understanding of the study, provision of written informed consent, willingness and ability to comply with all study procedures.
  • Age ≥ 18 years, male or female.
  • Histopathologically confirmed high-grade B-cell lymphoma, including:
  • diffuse large B-cell lymphoma (DLBCL), NOS; T-cell/histiocyte-rich large B-cell lymphoma; EBV-positive DLBCL, NOS; primary mediastinal large B-cell lymphoma; ALK-positive large B-cell lymphoma; high-grade B-cell lymphoma, NOS; high-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangements.
  • No prior anti-tumor therapy including chemotherapy, radiotherapy, immunotherapy, or other anti-lymphoma treatments.
  • Intermediate or high risk of central nervous system (CNS) involvement (meeting any one of the following):
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  • Primary breast lymphoma or primary testicular lymphoma;
  • Involvement of any of the following sites: testis, breast, kidney, adrenal gland, paranasal sinus, epidural space, uterus;
  • CNS-IPI score ≥ 4;
  • Double-protein expression of MYC (≥40% positive) and BCL2 (≥50% positive);
  • Gene rearrangements of MYC, BCL2 and/or BCL6.
  • ECOG performance status ≤ 2.
  • Life expectancy ≥ 3 months.
  • No evidence of CNS involvement (no brain parenchymal lesions on MRI and no malignant cells in CSF).
  • Adequate organ and bone marrow function without severe hematologic, cardiac, pulmonary, hepatic, renal dysfunction or immunodeficiency:
  • Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet ≥ 75 × 10⁹/L, hemoglobin ≥ 9.0 g/dL.
  • If bone marrow is involved: platelet ≥ 50 × 10⁹/L, ANC ≥ 1.0 × 10⁹/L, hemoglobin ≥ 8.0 g/dL.
  • Hepatic function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN (≤ 5 × ULN if liver involvement).
  • Renal function: serum creatinine ≤ 1.5 × ULN.
  • Coagulation: INR ≤ 1.5 × ULN; PT and APTT ≤ 1.5 × ULN (unless on therapeutic anticoagulation with values within expected range).
  • Negative serum pregnancy test for females of childbearing potential. Effective contraception required from informed consent until 6 months after the last chemotherapy.
  • Negative ophthalmologic evaluation, including dilated fundoscopy, slit-lamp examination, and color fundus photography.

Who cannot join

  • History of other malignancy within the past 5 years.
  • Burkitt lymphoma, primary central nervous system lymphoma, or B-cell lymphoma transformed from indolent lymphoma.
  • Existing brain parenchymal or meningeal lymphoma involvement.
  • Patients who have received any form of CNS prophylaxis.
  • Patients who have received whole-brain radiotherapy or craniospinal irradiation.
  • Patients with obstructive hydrocephalus requiring neurosurgical intervention.
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  • Presence of any of the following known infections or conditions:
  • Active meningeal infection
  • Known human immunodeficiency virus (HIV) infection
  • Active tuberculosis
  • Active autoimmune disease
  • Interstitial lung disease or infectious pneumonia
  • Patients whose underlying conditions, in the investigator's judgment, may increase the risk associated with study drug treatment or confound the evaluation of adverse reactions.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Intrathecal Thiotepa as an Effective and Well-tolerated Strategy for Central Nervous System (CNS) Prophylaxis in High-risk Diffuse Large B-cell Lymphoma (DLBCL): a Prospective Phase II Study

This is a prospective, single-arm clinical study to evaluate the efficacy and safety of intrathecal thiotepa for the prevention of central nervous system (CNS) involvement in patients with high-aggressive B-cell lymphoma.

A total of 32 subjects will be enrolled, and the study is planned to last for 2 years.

Outcomes including CNS recurrence rate, time to CNS involvement, progression-free survival (PFS), overall survival (OS), and safety parameters will be assessed during the study.

Being tested
(RCHOP or an investigator's choice) plus IT thiotepa and dexamethasone
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • (RCHOP or an investigator's choice) plus IT thiotepa and dexamethasoneDrug

    Patients received standard immunochemotherapy (RCHOP or an investigator's choice) plus IT thiotepa (10 mg) and dexamethasone (5 mg) via LP on day 1 of each cycle for at least four cycles. Following LP, patients remained supine for 4-6 hours. CSF analyses were repeated with each IT administration. Concomitant HD-MTX was permitted for patients enrolled in parallel protocols and was accounted for in sensitivity analyses.

Study groups in NCT07493486
Study groupRoleWhat they receive
(RCHOP or an investigator's choice) plus IT thiotepa and dexamethasoneExperimentalNot described
Receives: Drug: (RCHOP or an investigator's choice) plus IT thiotepa and dexamethasone

What is being measured

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

  1. 2-year cumulative incidence of SCNS relapse

    2-year cumulative incidence of SCNS relapse (isolated or combined with systemic progression), adjudicated by an independent radiologic-neurologic panel.

    Measured: At 2 years after baseline (total study duration: 2 years)

Secondary outcomes (3)

  1. PFS

    2-year progression-free survival (PFS)

    Measured: At 2 years after baseline (total study duration: 2 years)

  2. OS

    2-year overall survival (OS)

    Measured: At 2 years after baseline (total study duration: 2 years)

  3. Safety

    Safety assessments were performed at baseline, on Day 1 of each cycle, and at the end of each treatment cycle. Additional safety evaluations were conducted 30 days after the last dose of study treatment

    Measured: Day 1 of each cycle, and at the end of each treatment cycle,and 30 days after the last dose of study treatment.

Timeline

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

  1. First posted25 Mar 2026
  2. Study start1 Feb 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493486
Sponsor's protocol ID
IRB-2022-9
Status last verified
Mar 2026
First submitted
5 Mar 2026
Last updated
25 Mar 2026
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 (RCHOP or an investigator's choice) plus IT thiotepa and dexamethasone in people with Diffuse Large B-Cell Lymphoma (DLBCL) and Intrathecal Chemotherapy, run by Zhejiang Cancer Hospital 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 22 inclusion and 13 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 25 Mar 2026. 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?

2-year cumulative incidence of SCNS relapse (time frame: At 2 years after baseline (total study duration: 2 years)). 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 NCT07493486.

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 25 Mar 2026.

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