💬In plain words
What the trial is, and whether it could suit you
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, metabol
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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