Primary CNS Lymphoma (PCNSL)Phase 2NCT05274139
Treatment of Primary CNS Lymphoma ( FTD )
A Phase 2 study testing HD-MTX-Ara-C regimen and FTD regimen in people with Primary CNS Lymphoma (PCNSL), run by Mingzhi Zhang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of FTD regiment (fotemustine, temozolomide and dexamethasone ) for patients with primary CNS lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 69 years
- Conditions the study is for
- Primary CNS Lymphoma (PCNSL)
- What is being tested?
- HD-MTX-Ara-C regimen and FTD regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2017to 2 Mar 2019
- 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 14 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age range 14-69 years old;KPS performance status≥60 or ECOG performance status 0-2; Estimated survival time > 3 months; Histological confirmed PCNSL; None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- volunteers who signed informed consent.
Who cannot join
- Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigato
Trial locations and contacts
1 site in 1 country.
China1 site
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: The Prospective Study of FTD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.
The purpose of this study is to evaluate the efficacy and safety of FTD regiment (fotemustine, temozolomide and dexamethasone ) for patients with primary CNS lymphoma.
Read the detailed description
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with PCNSL remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. The purpose of this study is to evaluate the efficacy and safety of FTD regiment(fotemustine, temozolomide and dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.
- Conditions
- Primary CNS Lymphoma (PCNSL)
- Being tested
- HD-MTX-Ara-C regimen, FTD regimen
- Keywords
- primary CNS lymphoma, chemotherapy, RR, PFS, OS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-MTX-Ara-C regimenDrug
Also called high-does metrotrexate and cytarabine
HD-MTX-Ara-C regimen high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine
1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
FTD regimenDrug
Also called fotemustine, temozolomide and dexamethasone
FTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
| Study group | Role | What they receive |
|---|---|---|
| FTD regimen | Experimental | FTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt, temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles. Receives: Drug: FTD regimen |
| HD-MTX-Ara-C regimen | Experimental | high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles. Receives: Drug: HD-MTX-Ara-C regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival
Measured: up to end of follow-up-phase(approximately 24 months)
Secondary outcomes (3)
response rate
response rate
Measured: every 6 weeks,up to completion of treatment(approximately 18 weeks )
overall survival
overall survival
Measured: up to the date of death (approximately 5 years)
median survival time
median survival time
Measured: 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 Mar 2022
- Study start2 Mar 2017
- Primary completion2 Mar 2019
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CNS Lymphoma (PCNSL)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou University
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
- Investigators
- Mingzhi zhang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274139
- Sponsor's protocol ID
- hnslblzlzx2017-3
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Study of FTD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.
- ClinicalTrials.gov ID
- NCT05274139
- Acronym / sponsor ID
- hnslblzlzx2017-3
- Conditions
- Primary CNS Lymphoma (PCNSL)
- Keywords
- primary CNS lymphoma, chemotherapy, RR, PFS, OS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Collaborators
- Zhengzhou University
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 10 Mar 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of FTD regiment (fotemustine, temozolomide and dexamethasone ) for patients with primary CNS lymphoma.
Detailed description
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with PCNSL remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. The purpose of this study is to evaluate the efficacy and safety of FTD regiment(fotemustine, temozolomide and dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTD regimen | Experimental | Drug: FTD regimenFTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt, temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles. |
| HD-MTX-Ara-C regimen | Experimental | Drug: HD-MTX-Ara-C regimenhigh-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles. |
Who may qualify
- Ages
- 14 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age range 14-69 years old;KPS performance status≥60 or ECOG performance status 0-2; Estimated survival time > 3 months; Histological confirmed PCNSL; None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- volunteers who signed informed consent.
Key exclusion criteria (1 listed)
- Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigato
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 |
|---|---|---|
| HD-MTX-Ara-C regimenAlso: high-does metrotrexate and cytarabineHD-MTX-Ara-C regimen high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles | Drug | HD-MTX-Ara-C regimen |
| FTD regimenAlso: fotemustine, temozolomide and dexamethasoneFTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles | Drug | FTD regimen |
Primary outcome
Progression-free survival
Time frame: up to end of follow-up-phase(approximately 24 months)
Progression-free survival
3 secondary outcomes
response rate
Time frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )
overall survival
Time frame: up to the date of death (approximately 5 years)
median survival time
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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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 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 2 study testing HD-MTX-Ara-C regimen and FTD regimen in people with Primary CNS Lymphoma (PCNSL), 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: finished, as of the sponsor's last update on 10 Mar 2022. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: up to end of follow-up-phase(approximately 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 10 Mar 2022.