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Lymphoma Patients With High-risk of Central Nervous System RelapsePhase 2NCT07481669

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

A Phase 2 study testing TEAM regimen (thiotepa, etoposide, cytarabine and melphalan) in people with Lymphoma Patients With High-risk of Central Nervous System Relapse, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
TEAM regimen (thiotepa, etoposide, cytarabine and melphalan)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
1 Mar 2026to 31 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Histopathologically confirmed systemic non-Hodgkin lymphoma at initial diagnosis and meets one of the following:
  • CNS IPI score (4-6 points)
  • kidney or adrenal gland involvement
  • testis or breast involvement
  • primary cutaneous DLBCL, leg type
  • CR or PR after induction therapy
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  • Age 18-70 years.
  • 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
  • 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.
  • Able to comply with the study protocol per investigator judgment.
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    Hangzhou, Zhejiang, 310000

    Yang Xu, PhD, +86 0571-89713679, yxu@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read more

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.

Being tested
TEAM regimen (thiotepa, etoposide, cytarabine and melphalan)
Keywords
autologous stem cell transplantation, TEAM conditioning

What participants receive

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

  • TEAM regimen (thiotepa, etoposide, cytarabine and melphalan)Drug

    TEAM regimen (thiotepa, etoposide, cytarabine and melphalan) in ASCT for NHL patients at high risk for CNS involvement

Study groups in NCT07481669
Study groupRoleWhat they receive
Patients receiving ASCT with TEAM conditioningExperimentalLymphoma patients at high risk of CNS relapse will undergo ASCT with TEAM conditioning
Receives: Drug: TEAM regimen (thiotepa, etoposide, cytarabine and melphalan)

What is being measured

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

  1. progression free survival(PFS)

    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 posted19 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07481669
Sponsor's protocol ID
2025-0738
Status last verified
Feb 2026
First submitted
15 Mar 2026
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sahin U, Gokmen A, Soydan E, Urlu SM, Merter M, Gokgoz Z, Arslan O, Ozcan M. Outcomes of Autologous Stem Cell Transplantation as a Consolidative Strategy for the Treatment of Primary and Isolated Secondary Central Nervous System Diffuse Large B Cell Lymphomas. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):e1-e13. doi: 10.1016/j.clml.2022.09.006. Epub 2022 Oct 9.

    PubMed 36344419
  • Sellner L, Boumendil A, Finel H, Choquet S, de Rosa G, Falzetti F, Scime R, Kobbe G, Ferrara F, Delmer A, Sayer H, Amorim S, Bouabdallah R, Finke J, Salles G, Yakoub-Agha I, Faber E, Nicolas-Virelizier E, Facchini L, Vallisa D, Zuffa E, Sureda A, Dreger P; EBMT Lymphoma Working Party. Thiotepa-based high-dose therapy for autologous stem cell transplantation in lymphoma: a retrospective study from the EBMT. Bone Marrow Transplant. 2016 Feb;51(2):212-218. doi: 10.1038/bmt.2015.273. Epub 2015 Nov 16.

    PubMed 26569093
  • Isidori A, Christofides A, Visani G. Novel regimens prior to autologous stem cell transplantation for the management of adults with relapsed/refractory non-Hodgkin lymphoma and Hodgkin lymphoma: alternatives to BEAM conditioning. Leuk Lymphoma. 2016 Nov;57(11):2499-509. doi: 10.1080/10428194.2016.1185785. Epub 2016 May 31.

    PubMed 27243412
  • Sakellari I, Mallouri D, Batsis I, Apostolou C, Konstantinou V, Abela EM, Douka V, Marvaki A, Karypidis K, Iskas M, Baliakas P, Kaloyannidis P, Yannaki E, Sotiropoulos D, Kouvatseas G, Smias C, Anagnostopoulos A. Carmustine, etoposide, cytarabine and melphalan versus a newly designed intravenous busulfan-based Busulfex, etoposide and melphalan conditioning regimen for autologous hematopoietic cell transplant: a retrospective matched-pair analysis in advanced Hodgkin and non-Hodgkin lymphomas. Leuk Lymphoma. 2015;56(11):3071-81. doi: 10.3109/10428194.2015.1028054. Epub 2015 Apr 7.

    PubMed 25760637
  • Kim JE, Lee DH, Yoo C, Kim S, Kim SW, Lee JS, Park CJ, Huh J, Suh C. BEAM or BuCyE high-dose chemotherapy followed by autologous stem cell transplantation in non-Hodgkin's lymphoma patients: a single center comparative analysis of efficacy and toxicity. Leuk Res. 2011 Feb;35(2):183-7. doi: 10.1016/j.leukres.2010.07.016. Epub 2010 Aug 3.

    PubMed 20684990
  • Puig N, de la Rubia J, Remigia MJ, Jarque I, Martin G, Cupelli L, Sanz GF, Lorenzo I, Sanz J, Martinez JA, Jimenez C, Sanz MA. Morbidity and transplant-related mortality of CBV and BEAM preparative regimens for patients with lymphoid malignancies undergoing autologous stem-cell transplantation. Leuk Lymphoma. 2006 Aug;47(8):1488-94. doi: 10.1080/10428190500527769.

    PubMed 16966258
  • Caballero MD, Rubio V, Rifon J, Heras I, Garcia-Sanz R, Vazquez L, Vidriales B, del Canizo MC, Corral M, Gonzalez M, Leon A, Jean-Paul E, Rocha E, Moraleda JM, San Miguel JF. BEAM chemotherapy followed by autologous stem cell support in lymphoma patients: analysis of efficacy, toxicity and prognostic factors. Bone Marrow Transplant. 1997 Sep;20(6):451-8. doi: 10.1038/sj.bmt.1700913.

    PubMed 9313877
  • Chen YB, Lane AA, Logan B, Zhu X, Akpek G, Aljurf M, Artz A, Bredeson CN, Cooke KR, Ho VT, Lazarus HM, Olsson R, Saber W, McCarthy P, Pasquini MC. Impact of conditioning regimen on outcomes for patients with lymphoma undergoing high-dose therapy with autologous hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2015 Jun;21(6):1046-1053. doi: 10.1016/j.bbmt.2015.02.005. Epub 2015 Feb 14.

    PubMed 25687795
  • Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kroger N, Mohty M; European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. 2019 Oct;54(10):1525-1552. doi: 10.1038/s41409-019-0516-2. Epub 2019 Apr 5.

    PubMed 30953028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TEAM regimen (thiotepa, etoposide, cytarabine and melphalan) in people with Lymphoma Patients With High-risk of Central Nervous System Relapse, run by Second Affiliated Hospital, Zhejiang 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 19 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: looking for participants now, as of the sponsor's last update on 19 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yang Xu, PhD (+86 0571-89713679, yxu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival(PFS) (time frame: 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 NCT07481669, which also lists 9 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 19 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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