[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2025-06-30

Brief Summary

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This study was conducted to evaluate the 2-year progression free survival rate of elderly patients with primary CNS lymphoma followed by combination of rituximab and methotrexate followed by rituximab and cytarabine.

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Detailed Description

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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.

Conditions

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Primary CNS Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

\[Induction phase\]

① After induction therapy (R-M) 2 times, first evaluation

* Complete, partial response or stable disease-\> next step
* Progressive disease-\> eliminated

② After Induction therapy (R-M) was added 3 times (total 5 times), 2nd evaluation
* Complete response -\> consolidation therapy progress
* Partial response or stable disease-\> R-M 2 additional administrations
* Progressive disease-\> eliminated

③ After Induction therapy (R-M) was added twice (7 times in total), 3rd evaluation
* Complete, partial response or stable disease-\> consolidation therapy
* Progressive disease-\> eliminated

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Induction+Consolidation chemotherapy

\[Induction phase\]

① After induction therapy (Rituximab-Methotrexate) 2 times, first evaluation

* Complete, partial response or stable disease-\> next step
* Progressive disease-\> eliminated

② After Induction therapy (Rituximab-Methotrexate) was added 3 times (total 5 times), 2nd evaluation
* Complete response -\> consolidation therapy(Rituximab-Cytarabine) progress
* Partial response or stable disease-\> Rituximab-Methotrexate 2 additional administrations
* Progressive disease-\> eliminated

③ After Induction therapy (Rituximab-Methotrexate) was added twice (7 times in total), 3rd evaluation
* Complete, partial response or stable disease-\> consolidation therapy(Rituximab-Cytarabine)
* Progressive disease-\> eliminated

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

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)

Methotrexate

Intervention Type DRUG

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

Cytarabine Injection

Intervention Type DRUG

3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9

Interventions

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Rituximab

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)

Intervention Type DRUG

Methotrexate

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

Intervention Type DRUG

Cytarabine Injection

3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9

Intervention Type DRUG

Other Intervention Names

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Truxima Inj Methotrexate Inj Cytarabine

Eligibility Criteria

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Inclusion Criteria

1. Histologically proven diagnosis of B-cell non-Hodgkin's lymphoma, exclusively localized in the central nervous system, cranial nerves, and/or eyes
2. No previous treatment; A tumorectomy on diagnostic purpose and/or use of glucocorticoids is allowed
3. Measurable lesion(s)
4. Age ≥ 60 years
5. Unfit patients for high-dose chemotherapy followed by autologous stem cell transplantation
6. Adequate organ functions

* Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L
* Platelets ≥ 50 x 109/L
* Hemoglobin ≥ 8.0 g/dL
* Serum Creatinine ≤ 1.5 x upper limit normal (ULN)
* Serum Bilirubin ≤ 1.5 x ULN
* AST and ALT ≤ 3 x ULN
7. Patients with adequately controlled HBV, HCV or HIV are allowed. In case of HBV (+), adequate anti-viral prophylaxis should be incorporated. In case of HIV (+), highly active anti-retroviral therapy should be incorporated.
8. Written informed consent
9. ECOG performance scale 0, 1 or 2
10. Life expectancy \> 3 months

Exclusion Criteria

1. T-cell or NK/T cell lymphoma
2. Any evidence of systemic non-Hodgkin's lymphoma as demonstrated by computed tomography scan of the neck, chest, abdomen, and pelvis and bone marrow examinations
3. Young and fit patients who are suitable for high-dose chemotherapy followed by autologous stem cell transplantation
4. Prior radiation therapy on target CNS lesion(s)
5. Concurrent severe or uncontrolled medical conditions, laboratory abnormalities or psychiatric disorders that would preclude the participants in the study by the discretion of attending physicians
6. Metachronous malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin, or CIN of uterine cervix, or prostate cancer that can be observed without treatment
7. Known hypersensitivity to the investigational agent(s)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No