Primary CNS LymphomaPhase 2NCT02934204
Temozolomide in Treatment of Patients With Primary Central Nervous System Lymphoma
A Phase 2 study testing methotrexate and temozolomide in people with Primary CNS Lymphoma, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Consolidation treatment for Primary Central Nervous System Diffuse Large B cell Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary CNS Lymphoma
- What is being tested?
- methotrexate and temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Feb 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) histology confirmed to be PCNSL. (2) lymphoma invasion in brain, meninges, cerebrospinal fluid, eye organ. (3) ECOG score less than 3 points (4) at least 1 of the lesions can be evaluated with a double diameter. (5) the life expectancy of more than 6 months. (6) less or equal to 75 years,or more or equal to 18 years. (7) to be able to comply with the requirements of the study and follow-up procedures.
- to sign the consent form to participate in the study. (9) having adequate organ function, defined as follows: Liver function, serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) equal to or less than 2 times the upper limit of normal (ULN).
- Bone marrow function: absolute neutrophil count more or equal to 1500/L, platelet count more than 100000/L,hemoglobin was greater than 9 g/dL.
- Renal function, serum creatinine or creatinine clearance rate (less than 1.5ULN Cockcroft-Gault formula based on the improvement of more than 50ml/min).
- women with childbearing potential must start to get the test results of serum / urine pregnancy test negative within 48 hours prior to study. Postmenopausal women who have at least 12 months of menopause can be treated as non fertile.
Who cannot join
- (1) patients with a history of other malignancies within five years (except for the full treatment of cervical carcinoma in situ or basal cell carcinoma or squamous cell skin cancer).
- had previously been treated with total cranial irradiation. (3) the upper digestive tract is lack of physical integrity, or suffering from malabsorption syndrome, or oral drug, or active gastric ulcer.
- suffering from any unstable systemic diseases (including active infection, significant cardiovascular disease, any significant liver and kidney or metabolic disorders), metabolic disorders, physical examination results or laboratory examination results of contraindication to the use of drugs, or may affect the treatment results of interpretation or increase the risk of complications in treatment of risk (5) patients with human immunodeficiency virus (HIV) transmitted in the form of blood or other body fluids.
- women in pregnancy and lactation. (7) women of childbearing age who do not want to use contraceptive measures during the study period and have sexual capacity of men.
- patients who do not want to sign informed consent. (9) patients who were not willing to follow up. (10) for any drugs or excipients of allergy. Exit the case: no matter what reason patients withdrew from the study of cases in time will be postponed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong general hospital
Guangzhou, Guangdong, 510080
Sichu Liu, MD PhD, +86 20 81884713 ext. 80411, sisi.lau@foxmail.com
About this study
Consolidation treatment for Primary Central Nervous System Diffuse Large B cell Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.
- Conditions
- Primary CNS Lymphoma
- Being tested
- methotrexate, temozolomide
- Keywords
- PCNSL, DLBCL, methotrexate, temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
temozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| MTX and Temozolomide | Experimental | Induction therapy:
Methotrexate 3.5g/m2 ivgtt d1 2weeks/cycle，total 8 cycles Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 4 cycles
Consolidation therapy:
PCNSL patients achieve CR,Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 12 cycles Receives: Drug: methotrexate; Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
Measured: 3 year
Secondary outcomes (3)
Chronic neurotoxicity
Measured: 3 year
Overall survival
Measured: 3 year
Completed response
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (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.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934204
- Sponsor's protocol ID
- GDREC2015431H(R1)
- Status last verified
- May 2016
- First submitted
- 13 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temozolomide in Treatment of Patients With Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT02934204
- Acronym / sponsor ID
- GDREC2015431H(R1)
- Conditions
- Primary CNS Lymphoma
- Keywords
- PCNSL, DLBCL, methotrexate, temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Consolidation treatment for Primary Central Nervous System Diffuse Large B cell Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTX and Temozolomide | Experimental | Drug: methotrexate, Drug: temozolomideInduction therapy: Methotrexate 3.5g/m2 ivgtt d1 2weeks/cycle，total 8 cycles Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 4 cycles Consolidation therapy: PCNSL patients achieve CR,Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 12 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (1) histology confirmed to be PCNSL. (2) lymphoma invasion in brain, meninges, cerebrospinal fluid, eye organ. (3) ECOG score less than 3 points (4) at least 1 of the lesions can be evaluated with a double diameter. (5) the life expectancy of more than 6 months. (6) less or equal to 75 years,or more or equal to 18 years. (7) to be able to comply with the requirements of the study and follow-up procedures.
- to sign the consent form to participate in the study. (9) having adequate organ function, defined as follows: Liver function, serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) equal to or less than 2 times the upper limit of normal (ULN).
- Bone marrow function: absolute neutrophil count more or equal to 1500/L, platelet count more than 100000/L,hemoglobin was greater than 9 g/dL.
- Renal function, serum creatinine or creatinine clearance rate (less than 1.5ULN Cockcroft-Gault formula based on the improvement of more than 50ml/min).
- women with childbearing potential must start to get the test results of serum / urine pregnancy test negative within 48 hours prior to study. Postmenopausal women who have at least 12 months of menopause can be treated as non fertile.
Key exclusion criteria (5 listed)
- (1) patients with a history of other malignancies within five years (except for the full treatment of cervical carcinoma in situ or basal cell carcinoma or squamous cell skin cancer).
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 |
|---|---|---|
| methotrexate | Drug | MTX and Temozolomide |
| temozolomide | Drug | MTX and Temozolomide |
Primary outcome
event free survival
Time frame: 3 year
3 secondary outcomes
Chronic neurotoxicity
Time frame: 3 year
Overall survival
Time frame: 3 year
Completed response
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- 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.
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 methotrexate and temozolomide in people with Primary CNS Lymphoma, run by Guangdong Provincial People's Hospital 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 5 inclusion and 5 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 14 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenyu Li, MD PhD (+86 20 81884713 ext. 80411, LiWY1206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event free survival (time frame: 3 year). 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 14 Oct 2016.