New stem cell combo aims to stop lymphoma from spreading to the brain
NCT ID NCT07481669
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a modified stem cell transplant regimen for lymphoma patients at high risk of the cancer spreading to the brain. About 45 adults who have already responded to initial treatment will receive high-dose chemotherapy with thiotepa, etoposide, cytarabine, and melphalan, followed by a transplant of their own stem cells. The goal is to see if this approach can improve how long patients live without the cancer getting worse, while being safer and more affordable than current options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
RECRUITINGHangzhou, Zhejiang, 310000, China
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Other studies related to the condition(s) this trial covers.
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