Primary Central Nervous System LymphomaPhase 4NCT04083066
Open Randomized Prospective Clinical Study of R-FPD Versus R-MAD Regimen in the Treatment of Primary Central Nervous System Lymphoma
A Phase 4 study testing rituximab in combination with methotrexate, cytarabine and dexamethasone in people with Primary Central Nervous System Lymphoma, run by Mingzhi Zhang at 1 site in China.
Trial summary
Comparison of the efficacy and safety of rituximab combined with fotemustine, pemetrexed, dexamethasone and rituximab in combination with methotrexate, cytarabine and dexamethasone as first-line regimens in the treatment of primary central nervous system lymphoma Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- rituximab in combination with methotrexate, cytarabine and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2019to 1 Apr 2024
- Phase
- Phase 4
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14-75 years old; KPS score ≥ 60 points or ECOG score ≤ 2 points; expected survival period of more than 3 months; CD20 positive; PCNSL confirmed by tissue biopsy pathology (limited to brain, spinal cord, meninges and eyes, without lymphoma involving other parts of the body); no chemotherapy contraindications (blood and physiological examination results <7 days); At least one measurable lesion according to the RECIST criteria; There are no other serious diseases that conflict with this plan; There is a possibility of follow-up; When using other anti-tumor drugs at different times during this treatment, bisphosphonate anti-bone transfer therapy and other symptomatic treatments may be applied; Can understand the situation of this study and sign the informed consent form.
- : Pathological histology is subject to consultation by pathologists at provincial hospitals.
Who cannot join
- Currently receiving other chemotherapy, radiotherapy and targeted therapy (chemotherapy within 3 weeks, radiotherapy within 2 weeks, or recovery from acute toxicity of any previous treatment); Pregnant or lactating women; There are any uncontrollable medical diseases (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia); combined with chemotherapy and other contraindications for chemotherapy; Those who have had other malignant tumors in the past; There are uncontrolled infected patients; Those who have a history of mental illness that is difficult to control; The investigator believes that it is not appropriate to participate in this test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, Pro.DR, 13838565629, mingzhi_zhang@126.com
About this study
Official title: Open Randomized Prospective Clinical Study of Rituximab Combined With Fotemustine, Pemetrexed, Dexamethasone Versus Rituximab Plus Methotrexate, Cytarabine, and Dexamethasone in the Treatment of Primary Central Nervous System Lymphoma
Comparison of the efficacy and safety of rituximab combined with fotemustine, pemetrexed, dexamethasone and rituximab in combination with methotrexate, cytarabine and dexamethasone as first-line regimens in the treatment of primary central nervous system lymphoma
Read the detailed description
This is an open, randomized, prospective, multicenter clinical study designed to compare the efficacy and safety of R-FPD and R-MAD as first-line regimens in the treatment of primary central nervous system lymphoma. A total of 20 patients plan to participate in the study. The primary endpoints were objective response rate (ORR) and progression-free survival (PFS) and secondary endpoints including overall survival (OS), and adverse events.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- rituximab in combination with methotrexate, cytarabine and dexamethasone
- Keywords
- rituximab, fotemustine, pemetrexed, ORR, OS, PFS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab in combination with methotrexate, cytarabine and dexamethasoneDrug
Rituximab 375mg/m2D0 is soluble in 0.9% NS concentration 1mg/ml, micro pump is pumped in 4h HD-methotrexate 3.5g/m2 D1 dissolved in 0.9% NS intravenous drip HD-cytarabine 1g/m2 Q12H D2-3 Dissolved in 250ml 5% GS intravenously
Dexamethasone 40mg D1-5 is dissolved in 100ml 5% GS intravenous drip (21 days is a cycle)
| Study group | Role | What they receive |
|---|---|---|
| Rituximab combined with formoterol, pemetrexed, dexamethasone | Experimental | Rituximab 375mg/m2D0 is soluble in 0.9% NS, concentration 1mg/ml, micro pump is pumped for 4h Fotemustine 100mg/m2 D1 dissolved in 250mL 0.9% NS, intravenously for 1h, protected from light Pemetrexed 600mg/m2 D1 dissolved in 100ml 0.9% NS, intravenously 1h Dexamethasone 40mg D1-5 Dissolved in 100 ml 5% GS, intravenously (21 days is a cycle) Receives: Drug: rituximab in combination with methotrexate, cytarabine and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Responder Rate
Measured: up to 24 months
PFS
Progression Free Survival
Measured: up to 24 months
Secondary outcomes (2)
OS
Overall Survival
Measured: up to 24 months
adverse events
Number of patients with adverse events
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start5 Sep 2019
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
- Investigators
- Mingzhi zhang, Dr., Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083066
- Sponsor's protocol ID
- hnslblzlzx20190221
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Prospective Clinical Study of Rituximab Combined With Fotemustine, Pemetrexed, Dexamethasone Versus Rituximab Plus Methotrexate, Cytarabine, and Dexamethasone in the Treatment of Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT04083066
- Acronym / sponsor ID
- hnslblzlzx20190221
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- rituximab, fotemustine, pemetrexed, ORR, OS, PFS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 10 Sep 2019 (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.
Comparison of the efficacy and safety of rituximab combined with fotemustine, pemetrexed, dexamethasone and rituximab in combination with methotrexate, cytarabine and dexamethasone as first-line regimens in the treatment of primary central nervous system lymphoma
Detailed description
This is an open, randomized, prospective, multicenter clinical study designed to compare the efficacy and safety of R-FPD and R-MAD as first-line regimens in the treatment of primary central nervous system lymphoma. A total of 20 patients plan to participate in the study. The primary endpoints were objective response rate (ORR) and progression-free survival (PFS) and secondary endpoints including overall survival (OS), and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab combined with formoterol, pemetrexed, dexamethasone | Experimental | Drug: rituximab in combination with methotrexate, cytarabine and dexamethasoneRituximab 375mg/m2D0 is soluble in 0.9% NS, concentration 1mg/ml, micro pump is pumped for 4h Fotemustine 100mg/m2 D1 dissolved in 250mL 0.9% NS, intravenously for 1h, protected from light Pemetrexed 600mg/m2 D1 dissolved in 100ml 0.9% NS, intravenously 1h Dexamethasone 40mg D1-5 Dissolved in 100 ml 5% GS, intravenously (21 days is a cycle) |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 14-75 years old; KPS score ≥ 60 points or ECOG score ≤ 2 points; expected survival period of more than 3 months; CD20 positive; PCNSL confirmed by tissue biopsy pathology (limited to brain, spinal cord, meninges and eyes, without lymphoma involving other parts of the body); no chemotherapy contraindications (blood and physiological examination results <7 days); At least one measurable lesion according to the RECIST criteria; There are no other serious diseases that conflict with this plan; There is a possibility of follow-up; When using other anti-tumor drugs at different times during this treatment, bisphosphonate anti-bone transfer therapy and other symptomatic treatments may be applied; Can understand the situation of this study and sign the informed consent form.
- : Pathological histology is subject to consultation by pathologists at provincial hospitals.
Key exclusion criteria (1 listed)
- Currently receiving other chemotherapy, radiotherapy and targeted therapy (chemotherapy within 3 weeks, radiotherapy within 2 weeks, or recovery from acute toxicity of any previous treatment); Pregnant or lactating women; There are any uncontrollable medical diseases (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia); combined with chemotherapy and other contraindications for chemotherapy; Those who have had other malignant tumors in the past; There are uncontrolled infected patients; Those who have a history of mental illness that is difficult to control; The investigator believes that it is not appropriate to participate in this test.
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 |
|---|---|---|
| rituximab in combination with methotrexate, cytarabine and dexamethasoneRituximab 375mg/m2D0 is soluble in 0.9% NS concentration 1mg/ml, micro pump is pumped in 4h HD-methotrexate 3.5g/m2 D1 dissolved in 0.9% NS intravenous drip HD-cytarabine 1g/m2 Q12H D2-3 Dissolved in 250ml 5% GS intravenously Dexamethasone 40mg D1-5 is dissolved in 100ml 5% GS intravenous drip (21 days is a cycle) | Drug | Rituximab combined with formoterol, pemetrexed, dexamethasone |
Primary outcome
ORR
Time frame: up to 24 months
Objective Responder Rate
PFS
Time frame: up to 24 months
Progression Free Survival
2 secondary outcomes
OS
Time frame: up to 24 months
adverse events
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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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.
Mingzhi zhang, Dr. principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rituximab in combination with methotrexate, cytarabine and dexamethasone in people with Primary Central Nervous System Lymphoma, run by Mingzhi Zhang at 1 site in China.
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 2 inclusion and 1 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 10 Sep 2019. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mingzhi zhang, Pro.Dr. (13838565629, Mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 10 Sep 2019.