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Enhanced dose - density chemotherapy of High dose methotrexate (HD-MTX) combined with radiotherapy for the treatment of primary central nervous system lymphoma:a single center, single arm, phase 2 clinical trial.

Enhanced dose - density chemotherapy of High dose methotrexate (HD-MTX) combined with radiotherapy for the treatment of primary central nervous system lymphoma:a single center, single arm, phase 2 clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011982
Enrollment
Unknown
Registered
2017-07-13
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-07-17

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

one:Dose density Improved High dose methotrexate (HD-MTX) chemotherapy

Sponsors

Cancer Center, Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients must meet the following criteria for study entry: 1. Aged 18 to 70 years old, ECOG performance status of 0, 1, or 2, Life expectancy of >12 weeks; 2. All patents are diagnosed as Primary central nervous system B cell lymphoma by pathology . Including postoperative patients; 3. Adequate hematologic and hepatic-renal function: Hemoglobin >=9 g/dl, Absolute neutrophil count >=1.5*10^9/L, Platelet count >=100*10^9/L, ALT = 12 months after the last chemotherapy; 6. Ability and willingness to comply with the study protocol.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: 1. Patients had previously received other treatment such as chemotherapy or radiotherapy (Not including surgery); 2. Refuse to provide the blood sample; 3. History of severe allergic or anaphylactic reactions to any drugs including the protocol; 4. All patients of reproductive potential refuse to use adequate methods of contraception during the treatment period and until >12 months after the last chemotherapy; 5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease, uncontrolled diabetes mellitus, pulmonary disease or severe hepatic and renal dysfunction; 6. Serious infections; 7. Contraindications of radiotherapy and chemotherapy; 8. History of other malignancy; 9. Mental disorder.

Design outcomes

Primary

MeasureTime frame
complete response;partial response;Overall Response rate;Grade 3/4 toxicities;Neurocognitive assessment;

Secondary

MeasureTime frame
Overall survival;Progression-Free Survival;

Countries

China

Contacts

Public ContactWeiping Tao

Renmin Hospital of Wuhan University

2217363691@qq.com+86 13971698695

Outcome results

None listed

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