[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma
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|ClinicalTrials.gov Identifier: NCT03569995|
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary CNS Lymphoma||Drug: Rituximab Drug: Methotrexate Drug: Cytarabine||Phase 2|
As described, standard therapy for patients with primary CNS lymphoma is not based on a high level of evidence yet, and studies in elderly patients with this disease are very limited. Based on the Korea National Cancer Incidence Database, it is estimated that about 100 ~ 150 cases of primary central nervous system lymphoma are diagnosed per year in Korea, but there is no analysis through prospective studies. As described previously, MTX monotherapy in elderly patients is relatively safe and does not reduce clinical utility. Although the autologous therapy may consider autologous stem cell transplantation, it is difficult to apply in elderly patients. Brain radiation therapy is not a primary consideration because it may cause neurological sequelae, especially in elderly patients. High-dose cytarabine is a safely administered drug that has been used extensively in clinical studies involving the treatment of elderly patients.Rituximab has not been studied prospectively for medications, doses, and intervals that are expected to play a role in patients with primary CNS lymphoma, as described above, and may be caused by reducing the number of cytotoxic anticancer drugs in elderly patients And to reduce the treatment effect.
Therefore, the authors propose a two-phase study in which R-A induction therapy is performed after R-M induction therapy in elderly patients with primary CNS lymphoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
① After induction therapy (R-M) 2 times, first evaluation
|Masking:||None (Open Label)|
|Official Title:||Combination of Rituximab and Methotrexate Followed by Rituximab and Cytarabine in Elderly Patients With Primary CNS Lymphoma|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||June 15, 2024|
|Estimated Study Completion Date :||June 15, 2025|
Experimental: Induction+Consolidation chemotherapy
① After induction therapy (Rituximab-Methotrexate) 2 times, first evaluation
500 mg/m2 + 5%DW 500 mL IVF Begin with 50 mg/hr (increase by 50 mg/hr per 30 min until 400 mg/hr is reached)
500 mg/m2 + 5%DW 200 mL IV over 15 minutes 3000 mg/m2 + 5%DW 500 mL IVF over 3 hrs Concurrent hydration and subsequent leucovorin rescue is mandatory
3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9
- 2-year progression free survival rate [ Time Frame: the time between the date of treatment start and the date of death due to any cause or date of disease, assessed up to 24 months ]From the end of the last patient's trial, the disease progression will be tracked for up to 2 years, and primary analysis and reporting will be conducted.
- progression free survival [ Time Frame: 2 years from the date of consent to the date of Progress disease f / u. ]Means the period from the date of consent to the date of disease progression, the time of death, or the last time the disease has not progressed or has confirmed its survival.
- overall survival [ Time Frame: Time between the start of treatment and the date of death.assessed up to 5 years] ]It measures the time from start of treatment to death.
- Frequency of Adverse events classified by each criterion by CTCAE v4.0 [ Time Frame: from the date of informed consent signature to 31 days after last drug administration. ]CTCAE v4 (Common Terminology Criteria for Adverse Events v4.0) In the present study, toxicities will be recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE), version 4.0. Then, the collected Toxicity is classified by CTCAE term and calculated as%, and a lot of AE will be detected.
- time to treatment failure [ Time Frame: Within 3 years ]Means the period from the date of consent to the date of the onset of the disease or to the discontinuation of treatment for any reason.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569995
|Contact: Wonseog Kim, M.Demail@example.com|
|Contact: Seokjin Kim, M.Dfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Gangnam-gu,, Korea, Republic of, 06351|
|Contact: Kaeun Park, CRA 82-70-7014-4162 email@example.com|
|Principal Investigator:||Wonseog Kim, M.D||Samsung Medical Center|