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

NCT03569995 | Unknown Phase 2 DMC

• 1 other identifier: 2017-12-103
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary CNS Lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival rate

  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.

  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

Secondary Outcomes (4)

• progression free survival

  2 years from the date of consent to the date of Progress disease f / u.

• overall survival

  Time between the start of treatment and the date of death.assessed up to 5 years]

• Frequency of Adverse events classified by each criterion by CTCAE v4.0

  from the date of informed consent signature to 31 days after last drug administration.

• time to treatment failure

  Within 3 years

Study Arms (1)

Induction+Consolidation chemotherapy

EXPERIMENTAL

\[Induction phase\] 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

Drug: Rituximab; Drug: Methotrexate; Drug: Cytarabine Injection

Interventions

Rituximab 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)

Also known as: Truxima Inj

Induction+Consolidation chemotherapy

Methotrexate 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

Also known as: Methotrexate Inj

Induction+Consolidation chemotherapy

Cytarabine Injection 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

Also known as: Cytarabine

Induction+Consolidation chemotherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven diagnosis of B-cell non-Hodgkin's lymphoma, exclusively localized in the central nervous system, cranial nerves, and/or eyes
• No previous treatment; A tumorectomy on diagnostic purpose and/or use of glucocorticoids is allowed
• Measurable lesion(s)
• Age ≥ 60 years
• Unfit patients for high-dose chemotherapy followed by autologous stem cell transplantation
• 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
• 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.
• Written informed consent
• ECOG performance scale 0, 1 or 2

You may not qualify if:

• T-cell or NK/T cell lymphoma
• 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
• Young and fit patients who are suitable for high-dose chemotherapy followed by autologous stem cell transplantation
• Prior radiation therapy on target CNS lesion(s)
• 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
• 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
• Known hypersensitivity to the investigational agent(s)

Sponsors & Collaborators

• Won Seog Kim: lead
• Celltrion: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu,, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

Rituximab; Methotrexate; Cytarabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Wonseog Kim, M.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wonseog Kim, M.D

CONTACT

82-3410-6548; wonseog.kim@samsung.com

Seokjin Kim, M.D

CONTACT

82-3410-1766; seokjin88.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: \[Induction phase\] 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

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 26, 2018
• Study Start: November 30, 2018
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)