ASCT With TEAM Conditioning for Lymphoma With High Risk of CNS Relapse

March 15, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Autologous Stem Cell Transplantation With TEAM (Thiotepa, Etoposide, Cytarabine, Melphalan) Conditioning for Lymphoma Patients With High Risk of Central Nervous System Relapse

In the era of novel therapeutic agents, high-dose conditioning chemotherapy combined with autologous hematopoietic stem cell transplantation (auto-HSCT) remains an important and feasible consolidation strategy for non-Hodgkin lymphoma, especially for high-risk and relapsed/refractory patients. It can effectively prolong progression-free survival and even overall survival in chemotherapy-sensitive lymphoma patients, and its application in domestic clinical practice has become increasingly widespread.

With long-term and extensive use of carmustine-based conditioning regimens, their limitations have become increasingly apparent: the drug is expensive and has limited accessibility. Early treatment-related toxicities include mucositis, nausea, vomiting, diarrhea, and hepatotoxicity. Late toxicities include reduced pulmonary diffusion capacity, chronic interstitial pulmonary fibrosis, metabolic syndrome, and cardiovascular complications, all of which have attracted increasing attention.

Thiotepa, a cell-cycle-nonspecific alkylating agent, not only inhibits DNA synthesis and kills tumor cells but also readily crosses the blood-brain barrier, has a short half-life and rapid metabolism, and its safety has been widely confirmed in clinical practice. It is an ideal agent for transplant conditioning.

In recent years, various thiotepa-based conditioning regimens have been used in auto-HSCT for different types of non-Hodgkin lymphoma, achieving favorable efficacy and safety profiles, and can partially replace the classic BEAM regimen.

Investigators at our center observed that among non-Hodgkin lymphoma patients eligible for auto-HSCT, some have involvement at special sites, such as the central nervous system, nerve roots inside or outside the spinal canal, reproductive organs (uterus, ovary, breast, testis), kidney/adrenal gland, and multiple extranodal sites (bone, colorectum), all of which confer a high risk of central nervous system recurrence. Meanwhile, the high cost of thiotepa limits its clinical use.

To benefit more patients with CNS-high-risk lymphoma, our center has adjusted the dosage of the existing TEAM regimen. In a 4-year retrospective study, 29 lymphoma patients with involvement at the above sites received modified TEAM conditioning chemotherapy followed by auto-HSCT. With a maximum follow-up of 3 years, 2 patients died of disease progression, 1 patient remained in stable condition after radiotherapy for relapse, and all other patients achieved long-term survival with stable disease.

Therefore, our center is applying to conduct a prospective study of this conditioning regimen to obtain more convincing clinical evidence, provide a stronger theoretical basis for auto-HSCT conditioning for more CNS-high-risk lymphoma patients, and explore a more effective, less toxic, and cost reasonable therapeutic strategy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yang Xu, PhD
  • Phone Number: +86 0571-89713679
  • Email: yxu@zju.edu.cn

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histopathologically confirmed systemic non-Hodgkin lymphoma at initial diagnosis and meets one of the following:

    1. CNS IPI score (4-6 points)
    2. kidney or adrenal gland involvement
    3. testis or breast involvement
    4. primary cutaneous DLBCL, leg type
  2. CR or PR after induction therapy
  3. Age 18-70 years.

  4. Adequate renal, hepatic, pulmonary, hematologic, and cardiac function:

    • Creatinine clearance (Cockcroft-Gault) ≥ 50 mL/min / serum creatinine ≤ 1.5 mg/dL
    • ALT and AST < 2.5 × upper limit of normal (ULN)
    • Total bilirubin < 1.5 × ULN
    • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
    • Platelet count ≥ 100 × 10⁹/L
    • Left ventricular ejection fraction ≥ 50%; no clinically significant pericardial effusion or ECG abnormalities
    • No clinically significant pleural effusion
    • Baseline oxygen saturation ≥ 95% at rest on room air
  5. Negative serum or urine pregnancy test for females of childbearing potential (females who have undergone sterilization or are postmenopausal for ≥ 2 years are considered non childbearing). All patients must practice effective contraception during study treatment.
  6. Able to comply with the study protocol per investigator judgment.
  7. Voluntary participation, understanding study procedures, and provision of written informed consent; For illiterate patients (potentially vulnerable population), a literate family member must be present and provide written consent.

Exclusion Criteria:

  1. Diagnosis of primary central nervous system lymphoma (PCNSL).
  2. Concurrent malignancy or life-threatening disease; or prior malignancy cured < 2 years.
  3. Grade ≥ 2 mucositis.
  4. Congestive heart failure, uncontrolled hypertension, or unstable cardiovascular disease.
  5. Uncontrolled infection.
  6. Uncontrolled progressive disease during the study.
  7. Prior allogeneic hematopoietic stem cell transplantation.
  8. Any condition that may interfere with safety or efficacy assessment.
  9. Severe hypersensitivity to any study drug.
  10. Pregnant or breastfeeding females.
  11. Males or females unwilling to use contraception from consent signature until 6 months after completion of study treatment.
  12. Unlikely to complete all required study visits/procedures (including follow up) per investigator judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients receiving ASCT with TEAM conditioning
Lymphoma patients at high risk of CNS relapse will undergo ASCT with TEAM conditioning
Drug: TEAM regimen (thiotepa, etoposide, cytarabine and melphalan)
TEAM regimen (thiotepa, etoposide, cytarabine and melphalan) in ASCT for NHL patients at high risk for CNS involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival(PFS)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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