Inert Non Hodgkin's LymphomaPhase 2NCT05073250
IBI376 Plus Rituximab in Patients With Untreated Indolent Lymphoma.
A Phase 2 study testing IBI376 and Rituximab in people with Inert Non Hodgkin's Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are the most common inert non Hodgkin's lymphoma (iNHL). The standard first-line treatment of advanced FL / MZL is based on rituximab. Whether combined with chemotherapy or not, iNHL can induce lasting remission, but most of it is usually incurable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inert Non Hodgkin's Lymphoma
- What is being tested?
- IBI376 and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 1 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, male or female;
- Grade 1-3a follicular lymphoma or marginal zone lymphoma derived from B cells was confirmed by pathology;
- Immunohistochemistry showed CD20 positive;
- Have not received systemic anti-tumor therapy in the past;
- Lugano stage is stage III-IV (Note: 2014 Lugano stage is adopted for non gastric or intranodal marginal zone lymphoma, and Lugano modified version of Ann Arbor stage system is adopted for gastrointestinal marginal zone lymphoma);
- Patients with Lugano stage I-II and recurrence only after radiotherapy can be included in the group;
Show all 31Show fewer
- For subjects who relapsed only after radiotherapy, radiotherapy was completed 12 weeks before the first application of IBI376;
- Patients with Helicobacter pylori (HP) - positive mucosa associated lymphoid tissue lymphoma (MALT) can be enrolled if their pathological tissue type has not changed after failure of anti HP treatment;
- Any tumor load with treatment indications and one of the following is met:
- Have any discomfort symptoms that affect normal work and life;
- The function of end organs was impaired;
- Hemocytopenia secondary to lymphoma invading bone marrow;
- Massive lesions;
- Sustained or rapid progression
- The presence of evaluable target lesions is defined as the presence of ≥ 1 lesion with the longest diameter (LD) measurement > 1.5cm and the longest vertical longitude (LPD) measurement ≥ 1.0cm assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Patients with splenic marginal zone lymphoma (SMZL) can be enrolled if there is no measurable target lesion, but there is a clear basis for lymphoma bone marrow infiltration (bone marrow smear, biopsy or flow cytometry);
- Eastern Cooperative Oncology Group（ECOG） physical fitness status is 0-2 points;
- Life expectancy ≥ 12 weeks;
- Subjects must be willing to undergo incision, resection or coarse needle lymph node or tissue biopsy, or provide lymph node or tissue biopsy of recently available archived tissue (at least 10 white films) for pathological review in the research center;
- Willing to use contraception according to the following criteria:
- Women of childbearing age (15 ~ 49 years old) must undergo pregnancy test within 7 days before starting treatment, and the result is negative;
- Women of childbearing age shall take effective contraceptive measures at least 120 days after the last administration of the study drug (the contraceptive success rate shall be at least 99%). The available methods with contraceptive success rate of at least 99% shall be communicated with the subjects and confirmed;
- Male subjects took effective contraceptive measures at least 93 days after the last administration of the study drug (the contraceptive success rate was at least 99%). The available methods with a contraceptive success rate of at least 99% shall be communicated with the subjects and confirmed;
- Infertile women (i.e. sterilized by hysterectomy and / or bilateral oophorectomy or amenorrhea ≥ 12 months and age > 45 years) are not subject to the above conditions a and b;
- Have sufficient bone marrow and organ functions (do not use growth factors to obtain normal values. Subjects with hemocytopenia caused by lymphoma bone marrow invasion are not subject to the following conditions a, b and c):
- Neutrophil count (ANC) ≥ 1.0 × 10^9/L；
- Hemoglobin ≥ 8.0g/dl;
- Platelet count ≥ 50 × 10^9/L；
- Total bilirubin ≤ 1.5 × The upper limit of normal value (ULN), Gilbert syndrome, cholestasis caused by hilar compression adenosis, biliary obstruction caused by liver involvement or lymphoma < 3 times ULN;
- Alanine aminotransferase / aspartate aminotransferase (ALT / AST) ≤ 2.5 × ULN or ≤ 5 × ULN (in the presence of liver invasion);
- Creatinine clearance calculated by Cockcroft Gault equation ≥ 40ml / min or glomerular filtration rate estimated by diet modified formula for renal disease ≥ 40ml / min / 1.73m^2;
- Lipase ≤ 1.5 × ULN.
Who cannot join
- Transformation from inert non-Hodgkin lymphoma to diffuse large B-cell lymphoma is known;
- Lymphoma involving the central nervous system;
- Known human immunodeficiency virus (HIV) infection or positive immunoassay;
- Viral infections that cannot be controlled by antiviral drugs, such as herpes virus infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc [Note: chronic Hepatitis B virus (HBV) carriers or inactive hepatitis B surface antigen (HBsAg) positive subjects can be enrolled, and HBV-DNA is lower than the lower limit of detection; hepatitis C virus (HCV) antibody negative patients can be enrolled, HCV antibody positive patients need to be tested for HCV-RNA, and if they are negative, they can be enrolled];
- There are active infectious diseases requiring treatment;
- Live vaccines were administered within 30 days before administration of the study drug;
Show all 22Show fewer
- Active autoimmune diseases requiring systemic treatment in the past 12 months (i.e. the use of drugs to improve the disease, corticosteroids or immunosuppressive drugs). Note: alternative therapy (such as thyroxine, insulin or physiological corticosteroid replacement therapy with adrenal or pituitary insufficiency, etc.) is not considered as a systemic treatment;
- Known allergy or severe reaction to IBI376 or rituximab or any excipients;
- History of severe allergic reaction;
- There is congestive heart failure or uncontrolled arrhythmia classified as III-IV by the New York Heart Association;
- Patients with clinically significant electrocardiogram abnormalities and potential risk of malignant arrhythmia;
- Clinically significant heart diseases, including unstable angina pectoris, acute myocardial infarction and or heart problems, occurred within 6 months before study administration;
- A history of stroke or intracranial hemorrhage within 3 months before the date of administration of the study drug;
- Major surgery or severe trauma occurred within 28 days before the start of treatment, or major side effects have not recovered;
- Major uncontrolled medical conditions, including but not limited to kidney, liver, blood, gastrointestinal tract, endocrine, lung, nerve, brain or mental diseases;
- There were other malignancies in the first 3 years of the disease, but did not include cured basal or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial neoplasia and cervical carcinoma in situ.
- Known mental or physical diseases will interfere with the cooperation with the test requirements, or disturb the test results or the interpretation of the test results, and in the opinion of the treatment researcher, will make the patient unfit to participate in the study;
- There are situations where the researcher's judgment will interfere with the whole process of the study; there are significant risks to the subjects; or interfere with the interpretation of the study data;
- Pregnant or lactating patients;
- Inability to swallow and retain oral drugs, malabsorption syndrome, diseases significantly affecting gastrointestinal function, total gastrectomy or small bowel resection, ulcerative colitis, symptomatic inflammatory bowel disease, partial or complete intestinal obstruction;
- Any prohibited drug, including potent cytochrome P450 3A4 (CYP3A4) inhibitor or inducer, was used or expected to be used during the study 14 days before the administration of the study drug or within 5 half lives, whichever is longer;
- Unable to understand or unwilling to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Biotherapeutic Department, Chinese PLA General Hospital
Beijing
Weidong Han, Ph.D, +86-10-55499341, hanwdrsw@sina.com
Jinhong Shi, M.D, +86-10-66997231, jinhongshi321@163.com
About this study
Official title: IBI376 Plus Rituximab in Patients With Untreated Indolent Lymphoma：a Single-center, Open-label, Phase II Clinical Trial.（REPLY Study）
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are the most common inert non Hodgkin's lymphoma (iNHL). The standard first-line treatment of advanced FL / MZL is based on rituximab. Whether combined with chemotherapy or not, iNHL can induce lasting remission, but most of it is usually incurable. Therefore, early treatment of advanced iNHL should focus on protecting the bone marrow function of patients. Although the first-line immunochemotherapy offer high efficacy but also high incidence of toxicity. Phosphatidylinositol 3-kinase (PI3K) pathway plays an important role in the occurrence and development of B-cell malignant tumors. Studies have shown that PI3K inhibitor alone has good antitumor effect and tolerance in patients with recurrent refractory iNHL. In addition, PI3K inhibitor combined with rituximab showed better prognosis compared with rituximab monotherapy in FL / MZL patients. Therefore, the chemo-free regime, PI3K inhibitor in combination with rituximab may explore a new avenue for FL and MZL patients.
Read the detailed description
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are the most common inert non Hodgkin's lymphoma (iNHL). Their natural courses are slow but highly variable. The standard first-line treatment of advanced FL / MZL is based on rituximab. Whether combined with chemotherapy or not, it can induce lasting remission, but it is usually incurable. Although the first-line immunochemotherapy regimen has high efficacy, it also has high toxicity. Cytotoxic chemotherapy is related to many side effects, including bone marrow suppression and immunosuppression, gastrointestinal and cardiac toxicity, neurotoxicity and the occurrence of secondary tumors. About 20% of FL patients relapse within 2 years after first-line chemotherapy. The overall prognosis of these patients is poor. The median age of FL / MZL diagnosis is over 60 years old. These patients cannot tolerate conventional immunochemotherapy due to old age or complications. Compared with young and non complicated patients, the long-term survival is significantly reduced.
Phosphatidylinositol 3-kinase (PI3K) pathway plays an important role in the occurrence and development of B-cell malignant tumors. IBI376 (INCB050465) is a second generation, effective and highly selective PI3Kδ inhibitor. Recently, the results of two key phase II clinical trials of CITADEL-203 and CITADEL-204 show that IBI376 monotherapy has a rapid and long-lasting high response rate in patients with recurrent or refractory iNHL, and is safe and tolerable. In addition, the CRONOS-3 study showed that copanlisib, an intravenous pan class I PI3K inhibitor, combined with rituximab showed better progression free survival and clinically significant improvement in objective remission rate compared with standard rituximab monotherapy in FL / MZL patients. In conclusion, we speculate that the chemotherapy free regimen of IBI376 combined with rituximab may produce deep and lasting remission in patients with FL and MZL.
This is a single center, open label, single arm phase II clinical trial, which is divided into cohort A (follicular lymphoma) and cohort B (marginal zone lymphoma). The two cohorts are carried out at the same time. A total of 40 patients were treated with IBI376 combined with rituximab. The primary objective of this study is to assess the feasibility of PI3K inhibitor IBI376 in combination with rituximab in patients with untreated FL and MZL. The primary objective of this study is to assess the feasibility of PI3K inhibitor IBI376 in combination with rituximab in patients with untreated FL and MZL. The exploratory objective is to evaluate the clinical predictive biomarkers for efficacy.
- Conditions
- Inert Non Hodgkin's Lymphoma
- Being tested
- IBI376, Rituximab
- Keywords
- PI3K inhibitor, rituximab, follicular lymphoma, marginal zone lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI376Drug
Also called PI3Kδ inhibitor
IBI376 is administered orally once daily at a dose of 20 mg for 8 weeks, followed by an oral dose of 2.5 mg once daily. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of IBI376 at an oral dose of 2.5 mg once daily.
RituximabBiological
Also called Anti-cluster of differentiation antigen 20 (CD20) monoclonal antibody
Rituximab is administered at a dose of 375 mg/m^2 intravenously in the first 4 weeks, once a week. Subsequently, rituximab will be dosed once every 4 weeks. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of rituximab at a dose of 375 mg/m^2 intravenously once every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Enrolled patients will be administered IBI376 plus rituximab, induction therapy for 6 cycles (28-day cycle). Patients assessed as partial response (PR) after 6 cycles of induction therapy will receive another 6 cycles of IBI376 combined with rituximab induction therapy. Receives: Drug: IBI376; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
The percentage of patients with CR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Measured: Within 6 months of induction therapy completion
Secondary outcomes (4)
Objective response rate (ORR)
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Measured: Within 6 months of induction therapy completion
Duration of response (DOR)
The time from the first recording of CR or PR evidence to disease progression or death from any cause was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Measured: Within 6 months of induction therapy completion
Progression-free survival（PFS）
Time from the date of first administration of the study drug to disease progression or death from any cause (any earliest date).
Measured: Within 6 months of induction therapy completion
Safety of study treatments when given in combination
Incidence of subjects occuring treatment related adverse events.
Measured: Up to 90 days after the last dose of study drugs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start31 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inert Non Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Weidong Han, Ph.D, Principal investigator, Biotherapeutic Department, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073250
- Sponsor's protocol ID
- CHN-PLAGH-BT-068
- Status last verified
- May 2023
- First submitted
- 8 Oct 2021
- Last updated
- 12 May 2023
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBI376 Plus Rituximab in Patients With Untreated Indolent Lymphoma：a Single-center, Open-label, Phase II Clinical Trial.（REPLY Study）
- ClinicalTrials.gov ID
- NCT05073250
- Acronym / sponsor ID
- CHN-PLAGH-BT-068
- Conditions
- Inert Non Hodgkin's Lymphoma
- Keywords
- PI3K inhibitor, rituximab, follicular lymphoma, marginal zone lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 11 Oct 2021 (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.
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are the most common inert non Hodgkin's lymphoma (iNHL). The standard first-line treatment of advanced FL / MZL is based on rituximab. Whether combined with chemotherapy or not, iNHL can induce lasting remission, but most of it is usually incurable. Therefore, early treatment of advanced iNHL should focus on protecting the bone marrow function of patients. Although the first-line immunochemotherapy offer high efficacy but also high incidence of toxicity. Phosphatidylinositol 3-kinase (PI3K) pathway plays an important role in the occurrence and development of B-cell malignant tumors. Studies have shown that PI3K inhibitor alone has good antitumor effect and tolerance in patients with recurrent refractory iNHL. In addition, PI3K inhibitor combined with rituximab showed better prognosis compared with rituximab monotherapy in FL / MZL patients. Therefore, the chemo-free regime, PI3K inhibitor in combination with rituximab may explore a new avenue for FL and MZL patients.
Detailed description
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are the most common inert non Hodgkin's lymphoma (iNHL). Their natural courses are slow but highly variable. The standard first-line treatment of advanced FL / MZL is based on rituximab. Whether combined with chemotherapy or not, it can induce lasting remission, but it is usually incurable. Although the first-line immunochemotherapy regimen has high efficacy, it also has high toxicity. Cytotoxic chemotherapy is related to many side effects, including bone marrow suppression and immunosuppression, gastrointestinal and cardiac toxicity, neurotoxicity and the occurrence of secondary tumors. About 20% of FL patients relapse within 2 years after first-line chemotherapy. The overall prognosis of these patients is poor. The median age of FL / MZL diagnosis is over 60 years old. These patients cannot tolerate conventional immunochemotherapy due to old age or complications. Compared with young and non complicated patients, the long-term survival is significantly reduced.
Phosphatidylinositol 3-kinase (PI3K) pathway plays an important role in the occurrence and development of B-cell malignant tumors. IBI376 (INCB050465) is a second generation, effective and highly selective PI3Kδ inhibitor. Recently, the results of two key phase II clinical trials of CITADEL-203 and CITADEL-204 show that IBI376 monotherapy has a rapid and long-lasting high response rate in patients with recurrent or refractory iNHL, and is safe and tolerable. In addition, the CRONOS-3 study showed that copanlisib, an intravenous pan class I PI3K inhibitor, combined with rituximab showed better progression free survival and clinically significant improvement in objective remission rate compared with standard rituximab monotherapy in FL / MZL patients. In conclusion, we speculate that the chemotherapy free regimen of IBI376 combined with rituximab may produce deep and lasting remission in patients with FL and MZL.
This is a single center, open label, single arm phase II clinical trial, which is divided into cohort A (follicular lymphoma) and cohort B (marginal zone lymphoma). The two cohorts are carried out at the same time. A total of 40 patients were treated with IBI376 combined with rituximab. The primary objective of this study is to assess the feasibility of PI3K inhibitor IBI376 in combination with rituximab in patients with untreated FL and MZL. The primary objective of this study is to assess the feasibility of PI3K inhibitor IBI376 in combination with rituximab in patients with untreated FL and MZL. The exploratory objective is to evaluate the clinical predictive biomarkers for efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: IBI376, Biological: RituximabEnrolled patients will be administered IBI376 plus rituximab, induction therapy for 6 cycles (28-day cycle). Patients assessed as partial response (PR) after 6 cycles of induction therapy will receive another 6 cycles of IBI376 combined with rituximab induction therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Age ≥ 18 years old, male or female;
- Grade 1-3a follicular lymphoma or marginal zone lymphoma derived from B cells was confirmed by pathology;
- Immunohistochemistry showed CD20 positive;
- Have not received systemic anti-tumor therapy in the past;
- Lugano stage is stage III-IV (Note: 2014 Lugano stage is adopted for non gastric or intranodal marginal zone lymphoma, and Lugano modified version of Ann Arbor stage system is adopted for gastrointestinal marginal zone lymphoma);
Key exclusion criteria (22 listed)
- Transformation from inert non-Hodgkin lymphoma to diffuse large B-cell lymphoma is known;
- Lymphoma involving the central nervous system;
- Known human immunodeficiency virus (HIV) infection or positive immunoassay;
- Viral infections that cannot be controlled by antiviral drugs, such as herpes virus infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc [Note: chronic Hepatitis B virus (HBV) carriers or inactive hepatitis B surface antigen (HBsAg) positive subjects can be enrolled, and HBV-DNA is lower than the lower limit of detection; hepatitis C virus (HCV) antibody negative patients can be enrolled, HCV antibody positive patients need to be tested for HCV-RNA, and if they are negative, they can be enrolled];
- There are active infectious diseases requiring treatment;
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 |
|---|---|---|
| IBI376Also: PI3Kδ inhibitorIBI376 is administered orally once daily at a dose of 20 mg for 8 weeks, followed by an oral dose of 2.5 mg once daily. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of IBI376 at an oral dose of 2.5 mg once daily. | Drug | Experimental arm |
| RituximabAlso: Anti-cluster of differentiation antigen 20 (CD20) monoclonal antibodyRituximab is administered at a dose of 375 mg/m^2 intravenously in the first 4 weeks, once a week. Subsequently, rituximab will be dosed once every 4 weeks. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of rituximab at a dose of 375 mg/m^2 intravenously once every 4 weeks. | Biological | Experimental arm |
Primary outcome
Complete response (CR) rate
Time frame: Within 6 months of induction therapy completion
The percentage of patients with CR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
4 secondary outcomes
Objective response rate (ORR)
Time frame: Within 6 months of induction therapy completion
Duration of response (DOR)
Time frame: Within 6 months of induction therapy completion
Progression-free survival（PFS）
Time frame: Within 6 months of induction therapy completion
Safety of study treatments when given in combination
Time frame: Up to 90 days after the last dose of study drugs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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.
Weidong Han, Ph.D principal investigator
Biotherapeutic Department, Chinese PLA General Hospital
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 IBI376 and Rituximab in people with Inert Non Hodgkin's Lymphoma, run by Chinese PLA General 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 31 inclusion and 22 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 12 May 2023. 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 Weidong Han, Ph.D (+86-10-55499341, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: Within 6 months of induction therapy completion). 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 12 May 2023.