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

October 19, 2020 updated by: Won Seog Kim

Combination of Rituximab and Methotrexate Followed by Rituximab and Cytarabine in Elderly Patients With Primary CNS Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: 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)
Other Names:
  • Truxima Inj
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
Other Names:
  • Methotrexate Inj
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
Other Names:
  • Cytarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years from the date of consent to the date of Progress disease f / u.
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.
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
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.
from the date of informed consent signature to 31 days after last drug administration.
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.
Within 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Won Seog Kim

Collaborators

Celltrion

Investigators

  • Principal Investigator: Wonseog Kim, M.D, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2018

Primary Completion (ANTICIPATED)

June 1, 2024

Study Completion (ANTICIPATED)

June 1, 2025

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

June 24, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-12-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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