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A clinical study on the use of thiotepa in combination with semustine and cytarabine for conditioning of autologous hematopoietic stem cell transplantation in primary central nervous system lymphoma

A clinical study on the use of thiotepa in combination with semustine and cytarabine for conditioning of autologous hematopoietic stem cell transplantation in primary central nervous system lymphoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111944
Enrollment
Unknown
Registered
2025-11-07
Start date
2025-11-07
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary central nervous system lymphoma

Interventions

Experimental group:Patients planning to undergo autologous hematopoietic stem cell transplantation will be treated with a transplantation pretreatment regimen of certipie + simustine + cytarabine

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 to 70 years old; 2. Patients with primary central nervous system lymphoma who have been diagnosed and have achieved PR or above after induction therapy can receive ASCT. 3. ECOG score: 0-2 points; 4. Expected survival period: >=3 months; 5. The functions of major organs are normal, and the laboratory test results meet the following standards: a. Alanine aminotransferase (ALT) =2106/kg; 7. Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent form in person.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2. Those with a history of bone marrow transplantation and/or hematopoietic stem cell transplantation; 3. There are other hematological diseases that affect bone marrow hematopoietic function; 4. Those who are allergic to the research drugs and their related metabolites; 5. Uncontrolled active infections; 6. Has a history of severe heart and lung diseases that cannot be controlled; 7. As determined by the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study; 8. Other circumstances that the researcher deems unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
2 years progression-free survival rate;

Secondary

MeasureTime frame
2 years overall survival rate;Safety;Overall survival;Event-free survival;Overall remission rate;Complete remission rate;

Countries

China

Contacts

Public ContactXiaoli Yuan

Henan Provincial People's Hospital

yuanxiaoli@126.com+86 371 65896920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026