Primary CNS LymphomaPhase 2NCT03569995
[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma
A Phase 2 study testing Rituximab, Methotrexate and Cytarabine Injection in people with Primary CNS Lymphoma, run by Won Seog Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Primary CNS Lymphoma
- What is being tested?
- Rituximab, Methotrexate and Cytarabine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2018to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Life expectancy > 3 months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu,, 06351
Kaeun Park, CRA, 82-70-7014-4162, kaeun.park@samsung.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary CNS Lymphoma
- Being tested
- Rituximab, Methotrexate, Cytarabine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Truxima Inj
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)
MethotrexateDrug
Also called Methotrexate Inj
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 InjectionDrug
Also called Cytarabine
3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Rituximab; Drug: Methotrexate; Drug: Cytarabine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 2 years from the date of consent to the date of Progress disease f / u.
overall survival
It measures the time from start of treatment to death.
Measured: 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
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.
Measured: from the date of informed consent signature to 31 days after last drug administration.
time to treatment failure
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.
Measured: Within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start30 Nov 2018
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CNS LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- \[Induction phase\] 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
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Won Seog Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Celltrion
- Responsible party
- Sponsor-investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Wonseog Kim, M.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569995
- Sponsor's protocol ID
- 2017-12-103
- Status last verified
- Oct 2020
- First submitted
- 7 May 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Rituximab and Methotrexate Followed by Rituximab and Cytarabine in Elderly Patients With Primary CNS Lymphoma
- ClinicalTrials.gov ID
- NCT03569995
- Acronym / sponsor ID
- 2017-12-103
- Conditions
- Primary CNS Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Won Seog KimUniversity, hospital or other
- Collaborators
- Celltrion
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- [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
| Arm | Type | Receives |
|---|---|---|
| Induction+Consolidation chemotherapy | Experimental | Drug: Rituximab, Drug: Methotrexate, Drug: Cytarabine Injection[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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Truxima Inj500 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) | Drug | Induction+Consolidation chemotherapy |
| MethotrexateAlso: Methotrexate Inj500 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 | Drug | Induction+Consolidation chemotherapy |
| Cytarabine InjectionAlso: Cytarabine3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9 | Drug | Induction+Consolidation chemotherapy |
Primary outcome
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.
4 secondary outcomes
progression free survival
Time frame: 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]
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.
time to treatment failure
Time frame: Within 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wonseog Kim, M.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Methotrexate and Cytarabine Injection in people with Primary CNS Lymphoma, run by Won Seog Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wonseog Kim, M.D (82-3410-6548, wonseog.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.