Diffuse Large B-Cell LymphomaPhase 1/2NCT07159906
Homoharringtonine, BCL-2 Inhibitor, Rituximab, and Prednisone in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 1/2 study testing Homoharringtonine, BCL-2 inhibitor and CD20 Antibody in people with Diffuse Large B-Cell Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma in China and worldwide. Although standard immunochemotherapy with Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine (Oncovin), and Prednisone (R-CHOP) achieves durable remissions in many patients, approximately… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- What is being tested?
- Homoharringtonine, BCL-2 inhibitor and CD20 Antibody
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2025to 1 Aug 2028
- Phase
- Phase 1/2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Phase II Inclusion Criteria
- Histopathologically confirmed CD20-positive diffuse large B-cell lymphoma;
- Age ≥18 years at enrollment, regardless of gender, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
- Disease is refractory to or progresses within one year after first-line standard therapy containing anti-CD20 monoclonal antibodies and anthracycline-based chemotherapy, or has failed or relapsed after second-line or later standard treatment regimens, or has relapsed after autologous hematopoietic stem cell transplantation (more than 6 months post-transplant);
- At least one measurable lesion present (as defined by the Lugano 2014 response criteria: measurable lesion is defined as a lymph node lesion with a longest diameter >1.5 cm on CT axial imaging, or an extranodal lesion with a longest diameter >1.0 cm, and 18F-FDG PET/CT positive lesion);
- Able to provide written informed consent and capable of understanding and complying with all study requirements.
Phase II Exclusion Criteria
- Patients with poor compliance or inability to attend regular follow-up visits;
- Presence of severe organ dysfunction, as judged by the investigator, that renders the patient unsuitable for participation in this trial;
- Absolute neutrophil count < 1.0 × 10⁹/L, platelet count < 50 × 10⁹/L, or hemoglobin < 80 g/L (excluding cases due to lymphoma bone marrow infiltration);
- Other factors, as determined by the investigator, that may lead to forced early withdrawal from the study, such as other serious medical conditions (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, or family/social factors that may affect patient safety or compliance;
- History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency diseases;
- Pregnant or breastfeeding women, and fertile patients unwilling to use contraception.
- Acute or chronic active hepatitis B or C infection, with HBV DNA > 2000 IU/mL or 10⁴ copies/mL, or HCV RNA > 10³ copies/mL;
- Central nervous system (CNS) metastases; however, patients with asymptomatic CNS metastases or those with symptoms that have been treated and stabilized for ≥4 weeks may be eligible;
- Prior history of allogeneic hematopoietic stem cell transplantation;
- Cardiac dysfunction: baseline Corrected QT interval (QTc) ≥ 500 ms; Left Ventricular Ejection Fraction (LVEF) < 45%, or New York Heart Association (NYHA) classification Class III/IV heart failure;
- Known severe hypersensitivity to benzyl alcohol or any other components of the study drugs;
- Requirement for concomitant use of strong CYP3A4 inducers due to medical necessity.
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
Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: A Phase Ib/II Prospective, Multicenter, Single-Arm Study of Homoharringtonine, BCL-2 Inhibitor, Rituximab and Prednisone in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma in China and worldwide. Although standard immunochemotherapy with Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine (Oncovin), and Prednisone (R-CHOP) achieves durable remissions in many patients, approximately 30-40% experience relapse or refractory disease with poor outcomes. Novel strategies are needed for patients who are not candidates for transplantation or who relapse after multiple lines of therapy.
Homoharringtonine (HHT) is a natural cephalotaxine alkaloid extracted from Cephalotaxus species, clinically approved in China for acute and chronic myeloid leukemias. It inhibits ribosomal protein synthesis, modulates oncogenic and epigenetic signaling pathways, and induces apoptosis through mitochondrial and stress-activated pathways. Importantly, HHT downregulates the anti-apoptotic protein Myeloid Cell Leukemia 1 (MCL-1), a critical resistance factor to B-cell lymphoma 2 (BCL-2) inhibitors. This provides a strong mechanistic rationale for combining HHT with a BCL-2 inhibitor, together with rituximab and prednisone, in relapsed/refractory DLBCL.
This prospective, multicenter, single-arm, Phase Ib/II study will evaluate the safety, tolerability, and efficacy of HHT, a BCL-2 inhibitor, rituximab, and prednisone in adult patients with relapsed/refractory DLBCL. Phase Ib will enroll 15-22 patients to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and the recommended phase II dose (RP2D) of HHT. Phase II will enroll 40 patients treated at RP2D to evaluate the overall response rate (ORR) after 3 and 6 cycles per Lugano 2014 criteria. Secondary endpoints include complete remission (CR), partial remission (PR), progression-free survival (PFS), and overall survival (OS). Exploratory analyses will incorporate molecular biomarkers such as genomic profiling, circulating tumor DNA (ctDNA), and spatial transcriptomics.
Read the detailed description
This study is a prospective, multicenter, single-arm, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, and efficacy of homoharringtonine (HHT), a B-cell lymphoma 2 (BCL-2) inhibitor, rituximab, and prednisone in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Despite the curative potential of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), approximately 30-40% of patients experience relapse or refractory disease, and outcomes remain poor, especially in those not eligible for transplantation or those relapsing after multiple prior therapies.
Homoharringtonine is a cephalotaxine alkaloid approved in China for myeloid malignancies. It inhibits protein synthesis and downregulates Myeloid Cell Leukemia 1 (MCL-1), an important resistance factor to BCL-2 inhibition. Venetoclax (or Lisaftoclax, depending on study drug) is a selective oral BCL-2 inhibitor that restores apoptosis in tumor cells. Preclinical data demonstrate synergistic cytotoxicity when combining HHT with BCL-2 inhibition through complementary apoptotic mechanisms. Rituximab, an anti-CD20 monoclonal antibody, and prednisone, a glucocorticoid, further enhance anti-lymphoma activity and are established components of immunochemotherapy.
Phase Ib will use a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended Phase II dose (RP2D) of HHT. Phase II will subsequently treat patients at the RP2D to assess overall response rate (ORR) as the primary efficacy endpoint, evaluated after 3 and 6 cycles according to Lugano 2014 criteria. Secondary endpoints include complete remission (CR), partial remission (PR), progression-free survival (PFS), overall survival (OS), and safety outcomes.
Exploratory biomarker analyses will be performed to investigate predictors of treatment response. These include targeted gene sequencing, monitoring of circulating tumor DNA (ctDNA), and spatial transcriptomic profiling in selected patients. The findings are expected to provide important insights into the clinical potential of HHT combined with BCL-2 inhibition in relapsed/refractory DLBCL, and may inform the design of biomarker-guided treatment strategies in the future.
- Conditions
- Diffuse Large B-Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- Being tested
- Homoharringtonine, BCL-2 inhibitor, CD20 Antibody, Glucocorticoid (GC)
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomoharringtonineDrug
Also called HHT
A cephalotaxine alkaloid and protein synthesis inhibitor that downregulates Myeloid Cell Leukemia 1 (MCL-1), administered intravenously in 21-day cycles. Dose escalation in Phase Ib will determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D).
BCL-2 inhibitorDrug
Also called Lisaftoclax, APG-2575
An oral selective BCL2 inhibitor administered once daily D1-7. Combined with homoharringtonine, rituximab, and prednisone in 21-day cycles.
CD20 AntibodyDrug
Also called Rituximab
An anti-CD20 monoclonal antibody administered intravenously, used in combination with chemotherapy or targeted regimens for B-cell malignancies.
Glucocorticoid (GC)Drug
Also called Prednisone
glucocorticoid , given as part of the combination regimen to enhance anti-lymphoma effect.
| Study group | Role | What they receive |
|---|---|---|
| HHT-Based Combination | Experimental | Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will receive the investigational combination of homoharringtonine, BCL2 inhibitor, rituximab, and prednisone. Treatment will be administered in 21-day cycles, with dose escalation in Phase Ib to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D), followed by a Phase II expansion to evaluate efficacy and safety. Receives: Drug: Homoharringtonine; Drug: BCL-2 inhibitor; Drug: CD20 Antibody; Drug: Glucocorticoid (GC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLT)
Incidence of dose-limiting toxicities assessed during Cycle 1, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Cycle 1 (first 21-day cycle)
Maximum Tolerated Dose (MTD)
The highest dose level at which ≤1 out of 6 patients experience a DLT, determined during dose-escalation phase.
Measured: End of Phase Ib dose-escalation
Recommended Phase II Dose (RP2D)
RP2D determined based on DLT, MTD, safety, and preliminary efficacy findings in Phase Ib.
Measured: End of Phase Ib dose-escalation
Overall Response Rate (ORR)
Proportion of patients achieving CR or PR, assessed per Lugano 2014 criteria using Positron Emission Tomography-Computed Tomography (PET-CT) or Computed Tomography (CT).
Measured: At Cycle 3 and Cycle 6
Secondary outcomes (4)
Complete Response (CR) Rate
Proportion of patients achieving complete response, assessed per Lugano 2014 criteria using PET-CT/CT.
Measured: At Cycle 3 and Cycle 6
Partial Response (PR) Rate
Proportion of patients achieving partial response, assessed per Lugano 2014 criteria using PET-CT/CT.
Measured: At Cycle 3 and Cycle 6
Progression-Free Survival (PFS)
Time from enrollment to disease progression or death from any cause, whichever occurs first.
Measured: Up to 24 months from enrollment
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: Up to 24 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start8 Sep 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159906
- Sponsor's protocol ID
- IIT20250087C-R2
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD) outside the study group.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Prospective, Multicenter, Single-Arm Study of Homoharringtonine, BCL-2 Inhibitor, Rituximab and Prednisone in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07159906
- Acronym / sponsor ID
- IIT20250087C-R2
- Conditions
- Diffuse Large B-Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 8 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 8 Sep 2025 (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.
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma in China and worldwide. Although standard immunochemotherapy with Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine (Oncovin), and Prednisone (R-CHOP) achieves durable remissions in many patients, approximately 30-40% experience relapse or refractory disease with poor outcomes. Novel strategies are needed for patients who are not candidates for transplantation or who relapse after multiple lines of therapy.
Homoharringtonine (HHT) is a natural cephalotaxine alkaloid extracted from Cephalotaxus species, clinically approved in China for acute and chronic myeloid leukemias. It inhibits ribosomal protein synthesis, modulates oncogenic and epigenetic signaling pathways, and induces apoptosis through mitochondrial and stress-activated pathways. Importantly, HHT downregulates the anti-apoptotic protein Myeloid Cell Leukemia 1 (MCL-1), a critical resistance factor to B-cell lymphoma 2 (BCL-2) inhibitors. This provides a strong mechanistic rationale for combining HHT with a BCL-2 inhibitor, together with rituximab and prednisone, in relapsed/refractory DLBCL.
This prospective, multicenter, single-arm, Phase Ib/II study will evaluate the safety, tolerability, and efficacy of HHT, a BCL-2 inhibitor, rituximab, and prednisone in adult patients with relapsed/refractory DLBCL. Phase Ib will enroll 15-22 patients to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and the recommended phase II dose (RP2D) of HHT. Phase II will enroll 40 patients treated at RP2D to evaluate the overall response rate (ORR) after 3 and 6 cycles per Lugano 2014 criteria. Secondary endpoints include complete remission (CR), partial remission (PR), progression-free survival (PFS), and overall survival (OS). Exploratory analyses will incorporate molecular biomarkers such as genomic profiling, circulating tumor DNA (ctDNA), and spatial transcriptomics.
Detailed description
This study is a prospective, multicenter, single-arm, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, and efficacy of homoharringtonine (HHT), a B-cell lymphoma 2 (BCL-2) inhibitor, rituximab, and prednisone in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Despite the curative potential of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), approximately 30-40% of patients experience relapse or refractory disease, and outcomes remain poor, especially in those not eligible for transplantation or those relapsing after multiple prior therapies.
Homoharringtonine is a cephalotaxine alkaloid approved in China for myeloid malignancies. It inhibits protein synthesis and downregulates Myeloid Cell Leukemia 1 (MCL-1), an important resistance factor to BCL-2 inhibition. Venetoclax (or Lisaftoclax, depending on study drug) is a selective oral BCL-2 inhibitor that restores apoptosis in tumor cells. Preclinical data demonstrate synergistic cytotoxicity when combining HHT with BCL-2 inhibition through complementary apoptotic mechanisms. Rituximab, an anti-CD20 monoclonal antibody, and prednisone, a glucocorticoid, further enhance anti-lymphoma activity and are established components of immunochemotherapy.
Phase Ib will use a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended Phase II dose (RP2D) of HHT. Phase II will subsequently treat patients at the RP2D to assess overall response rate (ORR) as the primary efficacy endpoint, evaluated after 3 and 6 cycles according to Lugano 2014 criteria. Secondary endpoints include complete remission (CR), partial remission (PR), progression-free survival (PFS), overall survival (OS), and safety outcomes.
Exploratory biomarker analyses will be performed to investigate predictors of treatment response. These include targeted gene sequencing, monitoring of circulating tumor DNA (ctDNA), and spatial transcriptomic profiling in selected patients. The findings are expected to provide important insights into the clinical potential of HHT combined with BCL-2 inhibition in relapsed/refractory DLBCL, and may inform the design of biomarker-guided treatment strategies in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HHT-Based Combination | Experimental | Drug: Homoharringtonine, Drug: BCL-2 inhibitor, Drug: CD20 Antibody, Drug: Glucocorticoid (GC)Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will receive the investigational combination of homoharringtonine, BCL2 inhibitor, rituximab, and prednisone. Treatment will be administered in 21-day cycles, with dose escalation in Phase Ib to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D), followed by a Phase II expansion to evaluate efficacy and safety. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HomoharringtonineAlso: HHTA cephalotaxine alkaloid and protein synthesis inhibitor that downregulates Myeloid Cell Leukemia 1 (MCL-1), administered intravenously in 21-day cycles. Dose escalation in Phase Ib will determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D). | Drug | HHT-Based Combination |
| BCL-2 inhibitorAlso: Lisaftoclax, APG-2575An oral selective BCL2 inhibitor administered once daily D1-7. Combined with homoharringtonine, rituximab, and prednisone in 21-day cycles. | Drug | HHT-Based Combination |
| CD20 AntibodyAlso: RituximabAn anti-CD20 monoclonal antibody administered intravenously, used in combination with chemotherapy or targeted regimens for B-cell malignancies. | Drug | HHT-Based Combination |
| Glucocorticoid (GC)Also: Prednisoneglucocorticoid , given as part of the combination regimen to enhance anti-lymphoma effect. | Drug | HHT-Based Combination |
Primary outcome
Dose-Limiting Toxicities (DLT)
Time frame: Cycle 1 (first 21-day cycle)
Incidence of dose-limiting toxicities assessed during Cycle 1, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Maximum Tolerated Dose (MTD)
Time frame: End of Phase Ib dose-escalation
The highest dose level at which ≤1 out of 6 patients experience a DLT, determined during dose-escalation phase.
Recommended Phase II Dose (RP2D)
Time frame: End of Phase Ib dose-escalation
RP2D determined based on DLT, MTD, safety, and preliminary efficacy findings in Phase Ib.
Overall Response Rate (ORR)
Time frame: At Cycle 3 and Cycle 6
Proportion of patients achieving CR or PR, assessed per Lugano 2014 criteria using Positron Emission Tomography-Computed Tomography (PET-CT) or Computed Tomography (CT).
4 secondary outcomes
Complete Response (CR) Rate
Time frame: At Cycle 3 and Cycle 6
Partial Response (PR) Rate
Time frame: At Cycle 3 and Cycle 6
Progression-Free Survival (PFS)
Time frame: Up to 24 months from enrollment
Overall Survival (OS)
Time frame: Up to 24 months from enrollment
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 8 Sep 2025.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) outside the study group.
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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 1/2 study testing Homoharringtonine, BCL-2 inhibitor and CD20 Antibody in people with Diffuse Large B-Cell Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by First Affiliated Hospital of Zhejiang 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?
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 8 Sep 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jie Jin, MD (+86 13505716779, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLT) (time frame: Cycle 1 (first 21-day cycle)). The study lists 4 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 8 Sep 2025.