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

Last updated: October 19, 2020
Sponsor: Won Seog Kim
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT03569995
2017-12-103
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically proven diagnosis of B-cell non-Hodgkin's lymphoma, exclusivelylocalized in the central nervous system, cranial nerves, and/or eyes

  2. No previous treatment; A tumorectomy on diagnostic purpose and/or use ofglucocorticoids is allowed

  3. Measurable lesion(s)

  4. Age ≥ 60 years

  5. Unfit patients for high-dose chemotherapy followed by autologous stem celltransplantation

  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

  1. 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 (+), highlyactive anti-retroviral therapy should be incorporated.

  2. Written informed consent

  3. ECOG performance scale 0, 1 or 2

  4. Life expectancy > 3 months

Exclusion

Exclusion Criteria:

  1. T-cell or NK/T cell lymphoma

  2. Any evidence of systemic non-Hodgkin's lymphoma as demonstrated by computed tomographyscan of the neck, chest, abdomen, and pelvis and bone marrow examinations

  3. Young and fit patients who are suitable for high-dose chemotherapy followed byautologous stem cell transplantation

  4. Prior radiation therapy on target CNS lesion(s)

  5. Concurrent severe or uncontrolled medical conditions, laboratory abnormalities orpsychiatric disorders that would preclude the participants in the study by thediscretion of attending physicians

  6. Metachronous malignancy other than adequately treated basal cell or squamous cellcarcinoma of the skin, or CIN of uterine cervix, or prostate cancer that can beobserved without treatment

  7. Known hypersensitivity to the investigational agent(s)

Study Design

Total Participants: 35
Study Start date:
November 30, 2018
Estimated Completion Date:
June 30, 2025

Study Description

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.

Connect with a study center

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351
    Korea, Republic of

    Active - Recruiting

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