Central Nervous System Lymphoma Clinical Trial
Official title:
A Single Arm, Phase II Clinical Trial of Orelabrutinib Combined With Pemetrexed in the Treatment for Patients With Relapsed/Refractory Central Nervous System Lymphoma
This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 21, 2026 |
Est. primary completion date | December 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 to 75 years old (including 18 and 75) 2. Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled 3. Having at least one measurable lesions 4. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator) 5. Life expectancy no less than 1 month 6. enough main organ function 7. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 8. Agreeing to sign the written informed consents Exclusion Criteria: 1. Poor peripheral disease control of secondary central nervous system lymphoma 2. Patients used pemetrexed or orelabrutinib in the past 3. Active malignant tumor need be treated at the same time 4. Other malignant tumor history 5. Serious surgery and trauma less than two weeks 6. Patients with active tuberculosis 7. Systemic therapy for serious acute/chronic infection 8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 9. HIV-positive, AIDS patients and untreated active hepatitis 10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 11. Patients with a history of mental illness or drug abuse 12. Poor compliance during the trial and/or follow-up phase 13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial 14. Researchers determine unsuited to participate in this trial |
Country | Name | City | State |
---|---|---|---|
China | Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | objective response rate | the total proportion of patients with complete response (CR) and partial response (PR) | every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days) | |
Secondary | progression-free survival | the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first | every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days) | |
Secondary | overall survival | from date of first day of treatment to the date of death by any cause | every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days) | |
Secondary | The incidence of grade 3-4 adverse events | the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0) | up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04516655 -
A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients
|
Phase 2 | |
Recruiting |
NCT05054426 -
Intermediate Dose of IV MTX as CNS Prophylaxis for High Risk DLBCL
|
Phase 3 | |
Recruiting |
NCT02623010 -
Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma
|
Phase 2 | |
Recruiting |
NCT04548648 -
A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas
|
Phase 2 | |
Active, not recruiting |
NCT00293475 -
Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT03342586 -
Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity
|
||
Terminated |
NCT02420795 -
Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT01011920 -
Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
|
Phase 2 | |
Completed |
NCT00967200 -
Study of Tissue Samples From Patients With Glioma or Other Brain Tumors
|
N/A | |
Recruiting |
NCT03684980 -
LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma
|
Early Phase 1 | |
Not yet recruiting |
NCT06213636 -
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
|
Phase 1/Phase 2 | |
Recruiting |
NCT04938297 -
Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma
|
Phase 2 | |
Recruiting |
NCT04792489 -
DALY II USA/ MB-CART2019.1 for DLBCL
|
Phase 2 | |
Completed |
NCT01458730 -
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
|
Phase 2 | |
Completed |
NCT00153530 -
Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)
|
Phase 4 | |
Recruiting |
NCT04186520 -
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05816746 -
Decitabine and Anti-PD-1 in R/R DLBCL
|
Phase 2 | |
Recruiting |
NCT06031194 -
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
|
||
Active, not recruiting |
NCT03962127 -
MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway
|
||
Completed |
NCT03690895 -
Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy
|