Primary Central Nervous System Lymphoma (PCNSL)Phase 2NCT06646211
High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed PCNSL (MTZ)
A Phase 2 study testing Zanubrutinib , Thiotepa, Methotrexate , Thiotepa and Zanubrutinib and ASCT±Zanubrutinib in people with Primary Central Nervous System Lymphoma (PCNSL) and Non Hodgkin Lymphoma (NHL), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a phase Ⅱ clinical study of Zanubrutinib(Z) in combination with methotrexate (M) and thiotepa(T) in treating newly diagnosed primary CNS lymphoma (PCNSL). The purpose of the study is to test the efficacy and tolerability of a combination treatment of MTZ regimen in treating patients who have newly diagnosed… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL), Non Hodgkin Lymphoma (NHL)
- What is being tested?
- Zanubrutinib , Thiotepa, Methotrexate , Thiotepa and Zanubrutinib and ASCT±Zanubrutinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and woman who are 18 to 70 years of age
- Histologically documented PCNSL
- ECOG performance status ≤ 2
- Life expectancy of > 3 months
- Imaging show at least one measurable lesion in the central nervous system.
- Adequate bone marrow and organ function shown by:
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- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelets ≥ 75 x 10^9/L and no platelet transfusion within the past 14 days
- Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 14 days
- International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN
- Serum bilirubin ≤ 1.5×ULN
- Serum creatinine ≤ 2×ULN
- Lipase ≤ 1.5 x LUN
- Women of childbearing potential (WOCBP) and men must agree to use effective contraception when sexually active. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of medication; women who are pregnant or breastfeeding are not eligible to participate in this study. Women of childbearing potential: from the time of signing the Informed Consent Form (ICF) until 30 days after the study ends, sexually active men: from the time of signing the ICF until 90 days after the study ends, must use contraceptive measures.
- Must be able to tolerate MRI/CT scans
- Must be able to tolerate lumbar puncture and/or Ommaya tap
Who cannot join
- Diagnosed with a malignant tumor other than PCNSL or has received treatment, except for the following cases:
- Received curative treatment and has no known active disease at least 3 years or more before screening for enrollment.
- Fully treated non-melanoma skin cancer or malignant lentigo, with no evidence of disease.
- Fully treated carcinoma in situ, with no evidence of disease currently.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association > Class 2), unstable angina, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Uncontrolled hypertension despite optimal medical management (per investigators assessment)
Show all 19Show fewer
- Patient has poorly controlled diabetes (per investigators assessment)
- Patient is known to have an uncontrolled active systemic infection (>CTCAE grade 2) and recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug
- Cerebrovascular accident, deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment
- Non-healing wound, ulcer or bone fracture in a short time
- Known bleeding diathesis or hemophilia
- Known history of infection with human immunodeficiency virus (HIV) or active stage of infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) . Active HBV infection must be confirmed by a positive test for HBV surface antigen or a positive test for hepatitis B core antibody with a positive determination of HBV DNA by polymerase chain reaction (PCR). For Hepatitis C virus (HCV), confirmation must be made by a positive test for HCV antibodies, unless the subject has been treated and has shown a sustained virological response. Note: Subjects with positive HCV antibodies who have been treated and have shown a sustained virological response (negative virus detection for at least 6 months after completing treatment) will not be excluded.
- Patient underwent major systemic surgery ≤ 2 weeks prior to starting the trial treatment or who has not recovered from the side effects of such surgery
- Unable to swallow capsules or disease significantly affecting gastrointestinal function
- Life-threatening illness, medical conditions, or organ dysfunctions that may endanger the safety of the subject or put the study outcomes at risk.
- Lactating or pregnant
- Requires anticoagulation therapy with warfarin or equivalent vitamin K antagonists; requires treatment with potent CYP3A4/5 inhibitors.
- Requires long-term use of dexamethasone ≥4mg/day or equivalent doses of corticosteroid formulations.
- Requires treatment with immunosuppressive agents, including cyclosporine A, tacrolimus, and sirolimus. Patients must discontinue the use of immunosuppressive agents 28 days before receiving study medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
HuiQiang Huang, Professor, +86-020-87343350, huanghq@sysucc.org.cn
HuiQiang Huang, Professor
About this study
Official title: A Single-arm, Multicenter Phase Ⅱclinical Study Evaluating High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed Central Nervous System Diffuse Large B-cell Lymphoma (MTZ)
This is a phase Ⅱ clinical study of Zanubrutinib(Z) in combination with methotrexate (M) and thiotepa(T) in treating newly diagnosed primary CNS lymphoma (PCNSL).
The purpose of the study is to test the efficacy and tolerability of a combination treatment of MTZ regimen in treating patients who have newly diagnosed PCNSL
Read the detailed description
PCNSL is a rare extranodal aggressive lymphoma accounting for 4%- 6% of all extranodal lymphomas and 3%- 4% of brain tumors, with an overall low incidence rate. However, with the extension of life expectancy, the incidence of PCNSL has increased by 2-3 times in Western Europe and the United States over the past 20 years.
Conventional dose methotrexate (MTX) does not effectively cross the blood-brain barrier, and the treatment for newly diagnosed PCNSL is still based on high-dose methotrexate (HD-MTX) combined chemotherapy. In the early stages PCNSL, Batchelor et al. used an MTX dose of 8.0g/m², which could reach effective therapeutic concentrations in the cerebrospinal fluid (CSF). However, HD-MTX has significant nephrotoxicity, especially for elderly patients and those with renal insufficiency. In 2005, Khan et al. found that reducing the dose of MTX to 3.5g/m² could significantly reduce kidney toxicity. Although single-agent HD-MTX has some efficacy in treating PCNSL, the remission rate is still relatively low. High doses of cytarabine, dacarbazine, and thiotepa have a higher blood-brain barrier penetration rate, and these drugs combined with HD-MTX for treating PCNSL can further improve upon HD-MTX alone. The overall response rate (ORR) is approximately 60%-70%, the complete response (CR) rate is about 40%-50%, and the 5-year survival rate is around 30%. Neither the short-term efficacy nor the long-term survival is satisfactory.
Basic research has found that excessive activation of the BCR signaling pathway in PCNSL tumor tissue, and BTK inhibitors such as ibrutinib can effectively inhibit the BCR pathway to achieve therapeutic goals. A study used single agent ibrutinib to treat relapsed/refractory PCNSL, with an overall response rate (ORR) of 50%. Grommes et al. reported that ibrutinib combined with high-dose methotrexate (HD-MTX) with or without rituximab showed specific efficacy in treating relapsed/refractory PCNSL, with an ORR of 89% and a complete response (CR) rate of 67%. The efficacy was significantly higher than that of single-agent ibrutinib in treating relapsed/refractory PCNSL.
Based on these studies, we hypothesize that first-line treatment with BTK inhibitors combined with HD-MTX-based chemotherapy may further improve the efficacy of newly diagnosed PCNSL and prolong the duration of remission.However, as a first-generation BTK inhibitor, ibrutinib has a relatively high off-target effect, leading to increased drug resistance and adverse reaction rates. Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies. Previously, we conducted a phase II clinical study of ibrutinib combined with methotrexate and temozolomide in PCNSL, which showed that ibrutinib significantly improved patients' overall response rate and complete response rate. However, the duration of remission was relatively short. Therefore, this study uses the new generation of zanubrutinib and thiotepa, which have intense penetration into the central nervous system, aiming to improve patients' remission duration further.
At the same time, based on previous studies and clinical experience, elderly and patients with renal insufficiency have poor tolerance to methotrexate, often experiencing delayed MTX clearance and renal damage. The first four courses of this study removed methotrexate and only used the less toxic zanubrutiniba and thiotepa, providing a reference for future methotrexate-free treatment options.
- Being tested
- Zanubrutinib , Thiotepa, Methotrexate , Thiotepa and Zanubrutinib, ASCT±Zanubrutinib
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib , ThiotepaDrug
First 1-4 cycle
Drug: Thiotepa
- 40mg/m2，d1 each 21-day cycle from cycle 1 for up to 4 cycle Drug: Zanubrutinib
- Zanubrutinib will be given at a dose of 160mg，bid，d1-d21
Methotrexate , Thiotepa and ZanubrutinibDrug
Cycle 5 - 10 Drug: Methotrexate
- Intravenous methotrexate at 3.5g/m2 for 6 hours will be given on day 1 each 21-day cycle 【Leucovorin Calcium (CF): 15mg/m², rescue begins 12 hours after the infusion of methotrexate (MTX) ends, administered every 6 hours until the MTX plasma concentration is ≤ 0.1 μmol·L-¹ at 48 hours; plasma concentration monitoring time points: 0, 6, 24, 48, 72 hours.】 Other Names: MTX Drug: Thiotepa
- 40mg/m2，d1 each 21-day cycle from cycle 5 for up to 10 cycle Drug: Zanubrutinib Zanubrutinib will be given at a dose of 160mg，bid，d1-d21
ASCT±ZanubrutinibDrug
Consolidation / maintenance treatment Patients who achieve a Complete Response (CR) or Partial Response (PR) after the ZT/ZMT treatment will enter consolidation/maintenance therapy.
Patients age ≤65 years old will undergo Autologous Stem Cell Transplantation (ASCT, with a recommended conditioning regimen that includes Thiotepa), followed by 6 months of maintenance treatment with zanubrutinib.
Patients age > 65 will receive 6 months of maintenance treatment with zanubrutinib.
*The study permits the prophylactic use of Granulocyte Colony-Stimulating Factor (G-CSF). For detailed usage, please refer to the guidelines from the National Comprehensive Cancer Network (NCCN) or the Chinese Society of Clinical Oncology (CSCO)
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm： Experimental: Methotrexate , Thiotepa and Zanubrutinib(MTZ) | Experimental | Not described Receives: Drug: Zanubrutinib , Thiotepa; Drug: Methotrexate , Thiotepa and Zanubrutinib; Drug: ASCT±Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) at the end of TZ / MTZ treatment, Investigator-Assessed
The overall response rate (ORR) including complete response (CR), and partial response (PR) according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG)
Measured: 12 month
Secondary outcomes (5)
Overall Response Rate (ORR) at the end of TZ treatment, Investigator-Assessed
The overall response rate (ORR) including complete response (CR), and partial response (PR) according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG)
Measured: 12 month
Duration of response（DOR）
Duration of response is defined as the time from the date of first occurrence of CR or PR to the date of the first documented PD or death due to any cause.
Measured: 12 month
Progression-free survival (PFS)
defined as the time from treatment to disease progression or death from any cause.
Measured: 12 month
Overall survival (OS)
defined as the time from treatment to death from any cause
Measured: 12 month
Frequency and severity of adverse effects as defined by CTCAE version 5.0
All subjects who received at least one dose of MTZ will be included in the safety analysis. Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (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 Lymphoma (PCNSL)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646211
- Sponsor's protocol ID
- B2024-503-01
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Phase Ⅱclinical Study Evaluating High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed Central Nervous System Diffuse Large B-cell Lymphoma (MTZ)
- ClinicalTrials.gov ID
- NCT06646211
- Acronym / sponsor ID
- B2024-503-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 17 Oct 2024 (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 is a phase Ⅱ clinical study of Zanubrutinib(Z) in combination with methotrexate (M) and thiotepa(T) in treating newly diagnosed primary CNS lymphoma (PCNSL).
The purpose of the study is to test the efficacy and tolerability of a combination treatment of MTZ regimen in treating patients who have newly diagnosed PCNSL
Detailed description
PCNSL is a rare extranodal aggressive lymphoma accounting for 4%- 6% of all extranodal lymphomas and 3%- 4% of brain tumors, with an overall low incidence rate. However, with the extension of life expectancy, the incidence of PCNSL has increased by 2-3 times in Western Europe and the United States over the past 20 years.
Conventional dose methotrexate (MTX) does not effectively cross the blood-brain barrier, and the treatment for newly diagnosed PCNSL is still based on high-dose methotrexate (HD-MTX) combined chemotherapy. In the early stages PCNSL, Batchelor et al. used an MTX dose of 8.0g/m², which could reach effective therapeutic concentrations in the cerebrospinal fluid (CSF). However, HD-MTX has significant nephrotoxicity, especially for elderly patients and those with renal insufficiency. In 2005, Khan et al. found that reducing the dose of MTX to 3.5g/m² could significantly reduce kidney toxicity. Although single-agent HD-MTX has some efficacy in treating PCNSL, the remission rate is still relatively low. High doses of cytarabine, dacarbazine, and thiotepa have a higher blood-brain barrier penetration rate, and these drugs combined with HD-MTX for treating PCNSL can further improve upon HD-MTX alone. The overall response rate (ORR) is approximately 60%-70%, the complete response (CR) rate is about 40%-50%, and the 5-year survival rate is around 30%. Neither the short-term efficacy nor the long-term survival is satisfactory.
Basic research has found that excessive activation of the BCR signaling pathway in PCNSL tumor tissue, and BTK inhibitors such as ibrutinib can effectively inhibit the BCR pathway to achieve therapeutic goals. A study used single agent ibrutinib to treat relapsed/refractory PCNSL, with an overall response rate (ORR) of 50%. Grommes et al. reported that ibrutinib combined with high-dose methotrexate (HD-MTX) with or without rituximab showed specific efficacy in treating relapsed/refractory PCNSL, with an ORR of 89% and a complete response (CR) rate of 67%. The efficacy was significantly higher than that of single-agent ibrutinib in treating relapsed/refractory PCNSL.
Based on these studies, we hypothesize that first-line treatment with BTK inhibitors combined with HD-MTX-based chemotherapy may further improve the efficacy of newly diagnosed PCNSL and prolong the duration of remission.However, as a first-generation BTK inhibitor, ibrutinib has a relatively high off-target effect, leading to increased drug resistance and adverse reaction rates. Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies. Previously, we conducted a phase II clinical study of ibrutinib combined with methotrexate and temozolomide in PCNSL, which showed that ibrutinib significantly improved patients' overall response rate and complete response rate. However, the duration of remission was relatively short. Therefore, this study uses the new generation of zanubrutinib and thiotepa, which have intense penetration into the central nervous system, aiming to improve patients' remission duration further.
At the same time, based on previous studies and clinical experience, elderly and patients with renal insufficiency have poor tolerance to methotrexate, often experiencing delayed MTX clearance and renal damage. The first four courses of this study removed methotrexate and only used the less toxic zanubrutiniba and thiotepa, providing a reference for future methotrexate-free treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm： Experimental: Methotrexate , Thiotepa and Zanubrutinib(MTZ) | Experimental | Drug: Zanubrutinib , Thiotepa, Drug: Methotrexate , Thiotepa and Zanubrutinib, Drug: ASCT±Zanubrutinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men and woman who are 18 to 70 years of age
- Histologically documented PCNSL
- ECOG performance status ≤ 2
- Life expectancy of > 3 months
- Imaging show at least one measurable lesion in the central nervous system.
Key exclusion criteria (19 listed)
- Diagnosed with a malignant tumor other than PCNSL or has received treatment, except for the following cases:
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association > Class 2), unstable angina, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Uncontrolled hypertension despite optimal medical management (per investigators assessment)
- Patient has poorly controlled diabetes (per investigators assessment)
- Patient is known to have an uncontrolled active systemic infection (>CTCAE grade 2) and recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug
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 |
|---|---|---|
| Zanubrutinib , ThiotepaFirst 1-4 cycle Drug: Thiotepa * 40mg/m2，d1 each 21-day cycle from cycle 1 for up to 4 cycle Drug: Zanubrutinib * Zanubrutinib will be given at a dose of 160mg，bid，d1-d21 | Drug | Participant Group/Arm： Experimental: Methotrexate , Thiotepa and Zanubrutinib(MTZ) |
| Methotrexate , Thiotepa and ZanubrutinibCycle 5 - 10 Drug: Methotrexate * Intravenous methotrexate at 3.5g/m2 for 6 hours will be given on day 1 each 21-day cycle 【Leucovorin Calcium (CF): 15mg/m², rescue begins 12 hours after the infusion of methotrexate (MTX) ends, administered every 6 hours until the MTX plasma concentration is ≤ 0.1 μmol·L-¹ at 48 hours; plasma concentration monitoring time points: 0, 6, 24, 48, 72 hours.】 Other Names: MTX Drug: Thiotepa * 40mg/m2，d1 each 21-day cycle from cycle 5 for up to 10 cycle Drug: Zanubrutinib Zanubrutinib will be given at a dose of 160mg，bid，d1-d21 | Drug | Participant Group/Arm： Experimental: Methotrexate , Thiotepa and Zanubrutinib(MTZ) |
| ASCT±ZanubrutinibConsolidation / maintenance treatment Patients who achieve a Complete Response (CR) or Partial Response (PR) after the ZT/ZMT treatment will enter consolidation/maintenance therapy. Patients age ≤65 years old will undergo Autologous Stem Cell Transplantation (ASCT, with a recommended conditioning regimen that includes Thiotepa), followed by 6 months of maintenance treatment with zanubrutinib. Patients age > 65 will receive 6 months of maintenance treatment with zanubrutinib. *The study permits the prophylactic use of Granulocyte Colony-Stimulating Factor (G-CSF). For detailed usage, please refer to the guidelines from the National Comprehensive Cancer Network (NCCN) or the Chinese Society of Clinical Oncology (CSCO) | Drug | Participant Group/Arm： Experimental: Methotrexate , Thiotepa and Zanubrutinib(MTZ) |
Primary outcome
Overall Response Rate (ORR) at the end of TZ / MTZ treatment, Investigator-Assessed
Time frame: 12 month
The overall response rate (ORR) including complete response (CR), and partial response (PR) according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG)
5 secondary outcomes
Overall Response Rate (ORR) at the end of TZ treatment, Investigator-Assessed
Time frame: 12 month
Duration of response（DOR）
Time frame: 12 month
Progression-free survival (PFS)
Time frame: 12 month
Overall survival (OS)
Time frame: 12 month
Frequency and severity of adverse effects as defined by CTCAE version 5.0
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- 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.
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 Zanubrutinib , Thiotepa, Methotrexate , Thiotepa and Zanubrutinib and ASCT±Zanubrutinib in people with Primary Central Nervous System Lymphoma (PCNSL) and Non Hodgkin Lymphoma (NHL), run by Sun Yat-sen University 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 17 inclusion and 19 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: opening soon, as of the sponsor's last update on 17 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Gao, Doctor (+86 020 87343350, gaoyan@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) at the end of TZ / MTZ treatment, Investigator-Assessed (time frame: 12 month). 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 17 Oct 2024.