Autologous stem cell transplant with TEAM conditioning for lymphoma at high risk of CNS relapse

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

This trial tests whether high-dose TEAM chemotherapy followed by an autologous stem cell transplant helps adults with non-Hodgkin lymphoma who are at high risk of the cancer returning in the brain or spinal cord.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07481669 on ClinicalTrials.gov

What this trial studies

This single-center Phase 2 interventional trial uses a TEAM conditioning regimen (thiotepa, etoposide, cytarabine, melphalan) before autologous hematopoietic stem cell transplantation in patients with systemic non-Hodgkin lymphoma at high risk for CNS relapse. Eligible participants are adults 18–70 years old who achieved a complete or partial response after induction therapy and meet prespecified high-risk criteria such as a high CNS-IPI score or testis/breast/adrenal/kidney involvement. The protocol requires adequate organ function and inpatient administration of high-dose chemotherapy with supportive care for hematologic recovery. The study aims to determine tolerability and clinical benefit in prolonging progression-free and overall survival compared with historical outcomes after carmustine-based conditioning.

Who should consider this trial

Good fit: Adults aged 18–70 with systemic non-Hodgkin lymphoma who are in complete or partial remission after induction therapy and meet high-risk CNS relapse criteria, with adequate cardiac, pulmonary, hepatic, renal, and hematologic function, are ideal candidates.

Not a fit: Patients with active refractory disease, inadequate organ function, current CNS involvement, or who do not meet the high-risk CNS criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, TEAM conditioning before autologous transplant could offer an effective and more accessible alternative to carmustine-based regimens that may reduce certain late pulmonary and logistical toxicities.

How similar studies have performed: High-dose conditioning followed by autologous transplant is an established consolidation approach for chemo-sensitive lymphoma, and TEAM has been used as an alternative to carmustine with encouraging but more limited data compared with BCNU-based regimens.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yang Xu, PhD

Conditions Lymphoma Patients With High-risk of Central Nervous System Relapse; autologous stem cell transplantation; TEAM conditioning