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AzTrials

Relapsed/Refractory Diffuse Large B-cell LymphomaPhase 2/3NCT04442022

A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Phase 2/3 study testing Selinexor (combination therapy), Rituximab (combination therapy) and Gemcitabine (combination therapy) in people with Relapsed/Refractory Diffuse Large B-cell Lymphoma, run by Karyopharm Therapeutics Inc at 38 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Selinexor (combination therapy), Rituximab (combination therapy) and Gemcitabine (combination therapy)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
501 participants
Where
38 sitesin 6 countries
Study dates
3 Sep 2020to Dec 2026
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).
  • Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.
  • Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.
  • Maintenance therapy will not be counted as a separate line of systemic therapy.
  • Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.
  • Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.
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  • Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.
  • Adequate bone marrow function at screening, defined as:
  • Absolute neutrophil count (ANC) ≥1*10^9 per liter (/L).
  • Platelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).
  • Hemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).
  • Circulating lymphocytes less than or equal to (≤) 50*10^9/L.
  • Adequate liver and kidney function, defined as:
  • Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.
  • Serum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.
  • Calculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • An estimated life expectancy of >3 months at Screening.
  • Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.
  • Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment
  • Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).
  • Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.

Who cannot join

  • DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma.
  • Previous treatment with selinexor or other XPO1 inhibitors.
  • Contraindication to any drug contained in the combination therapy regimen (SR-GDP).
  • Known active central nervous system or meningeal involvement by DLBCL at time of Screening.
  • Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions).
  • Any AE, by C1D1, which has not recovered to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia.
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  • Major surgery <14 days of Cycle 1 Day 1.
  • Hematopoietic stem cell transplantation/CAR-T therapy as follows:
  • Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1
  • Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis)
  • CAR-T cell infusion <90 days prior to Cycle 1
  • Neuropathy Grade ≥2 (CTCAE, v.5.0).
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures.
  • Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
  • Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections:
  • Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units (IU)/mL prior to first dose of study treatment.
  • Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard.
  • Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year.
  • Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment.
  • Breastfeeding or pregnant women.
  • Inability or unwillingness to sign an informed consent form (ICF).
  • In the opinion of the Investigator, patient who are significantly below their ideal body weight.
  • Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.

Trial locations and contacts

38 sites in 6 countries.

38 sites in 6 countries

United States8 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • The Oncology Institute (TOI) Clinical Research

    Cerritos, California, 90703

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Norton Cancer Institute, St. Matthews

    Louisville, Kentucky, 40207

  • Stony Brook

    Stony Brook, New York, 11794

  • Arizona Oncology Associates

    Tucson, Arizona, 85711

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center

    Tyler, Texas, 75702

Other trials in United States

Italy8 sites

  • AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia

    Ancona, Ancona, 60020

  • UOC Ematologia ad Indirizzo Oncologico, AORN "Sant'Anna e San Sebastiano"

    Caserta, Caserta, 81100

  • National Cancer Institute

    Naples, Napoli, 1-80131

  • AOU Maggiore della Carità SCDU Ematologia

    Novara, Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    Palermo, Sicily, 90146

  • DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi

    Pescara, Pescara, 65124

  • Fondatione Policlinico Universitario A. Gemelli

    Rome, Rome, 00168

  • AOU City of Health and Science of Turin

    Turin, Torino, 10126

Other trials in Italy

Poland7 sites

  • Szpitale pomorskie gdynia dept of haematology

    Gdynia, Pomeranian Voivodeship, 81-519

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship, 40-523

  • Pratia MCM Krakow

    Krakow, Lesser, 30-510

  • CM Pratia Poznań

    Skorzewo, Wielkopolska, 60819

  • Institute of Hematology and Transfusion Medicine

    Warsaw, 00-791

  • Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-781

  • Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu

    Wroclaw, Radeckiego, 50-367

Other trials in Poland

China6 sites

  • Huaxi Hospital Sichuan University

    Chengdu, Sichuan, 610044

  • The first affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

    Huangpu, Shanghai Municipality, 200025

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Zhongshan Hospital Fudan University

    Xuhui, Shanghai Municipality, 200032

Other trials in China

Spain5 sites

  • Institut català d'oncologia-hospital germans trias i pujol

    Badalona, Barcelona, 08916

  • Hospital Vall Hebron

    Barcelona, Barcelona, 08035

  • Institut Catala D'oncolocia

    Barcelona, Barcelona, 09809

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Virgen del Rocío

    Seville, Seville, 41013

Other trials in Spain

Israel4 sites

  • Assuta Ashdod Medical Center

    Ashdod, 7747629

  • Soroka Medical Center

    Beersheba, 8457108

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Assuta Medical Center - Ramat Hachayal

    Tel Aviv, 6423906

Other trials in Israel

About this study

Official title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)

The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.

Being tested
Selinexor (combination therapy), Placebo matching for Selinexor (combination therapy), Rituximab (combination therapy), Gemcitabine (combination therapy), Dexamethasone (combination therapy)
Keywords
Relapsed/Refractory DLBCL, Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP), Selinexor, Karyopharm, KCP-330, XPOVIO, DLBCL, XPORT-DLBCL-030, R-GDP
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selinexor (combination therapy)Drug

    Dose: 40 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

  • Selinexor (combination therapy)Drug

    Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

  • Selinexor (combination therapy)Drug

    Dose: Selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

  • Placebo matching for Selinexor (combination therapy)Drug

    Dose: Placebo matching for selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

  • Rituximab (combination therapy)Drug

    Dose: 375 milligram per meter square (mg/m^2) on Day 1; Route of administration: intravenous (IV)

  • Rituximab (combination therapy)Drug

    Dose: 375 mg/m^2 on Day 1; Route of administration: IV

  • Gemcitabine (combination therapy)Drug

    Dose: 1000 mg/m^2 on Days 1 and 8; Route of administration: IV

  • Dexamethasone (combination therapy)Drug

    Dose: 40 mg (20 mg if patient is more than 70 years old) on Days 1, 2, 3, and 4; Route of administration: oral or IV

  • Cisplatin (combination therapy)Drug

    Dose: 75 mg/m^2 on Day 1; Route of administration: IV

  • Selinexor (continuous therapy)Drug

    Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral

  • Placebo matching for Selinexor (continuous therapy)Drug

    Dose: Placebo matching for 60 mg selinexor QW for each 28-day cycle until PD; Route of administration: oral

Study groups in NCT04442022
Study groupRoleWhat they receive
Phase 2: Selinexor 40 mg + R-GDPExperimentalPatients with RR DLBCL will receive combination therapy of selinexor 40 mg orally at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally once weekly (QW) for each 28-day cycle until progressive disease (PD) or unacceptable toxicity.
Receives: Drug: Selinexor (combination therapy); Drug: Rituximab (combination therapy); Drug: Gemcitabine (combination therapy); Drug: Dexamethasone (combination therapy); Drug: Cisplatin (combination therapy); Drug: Selinexor (continuous therapy)
Phase 2: Selinexor 60 mg + R-GDPExperimentalPatients with RR DLBCL will receive combination therapy of selinexor 60 mg orally at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.
Receives: Drug: Selinexor (combination therapy); Drug: Rituximab (combination therapy); Drug: Gemcitabine (combination therapy); Drug: Dexamethasone (combination therapy); Drug: Cisplatin (combination therapy); Drug: Selinexor (continuous therapy)
Phase 2: R-GDPActive comparatorPatients with RR DLBCL will receive R-GDP on specified days (Days 1, 2, 3, 4, and 8) for each 21-day cycle for up to 6 cycles.
Receives: Drug: Rituximab (combination therapy); Drug: Gemcitabine (combination therapy); Drug: Dexamethasone (combination therapy); Drug: Cisplatin (combination therapy)
Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mgExperimentalPatients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.
Receives: Drug: Selinexor (combination therapy); Drug: Rituximab (combination therapy); Drug: Gemcitabine (combination therapy); Drug: Dexamethasone (combination therapy); Drug: Cisplatin (combination therapy); Drug: Selinexor (continuous therapy)
Phase 3: Selinexor (Selected Dose) + R-GDP followed by PlaceboExperimentalPatients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.
Receives: Drug: Selinexor (combination therapy); Drug: Rituximab (combination therapy); Drug: Gemcitabine (combination therapy); Drug: Dexamethasone (combination therapy); Drug: Cisplatin (combination therapy); Drug: Placebo matching for Selinexor (continuous therapy)
Phase 3: Placebo + R-GDP followed by PlaceboPlacebo comparatorPatients with RR DLBCL will receive combination therapy of placebo matching for selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.
Receives: Drug: Placebo matching for Selinexor (combination therapy); Drug: Rituximab (combination therapy); Drug: Gemcitabine (combination therapy); Drug: Dexamethasone (combination therapy); Drug: Cisplatin (combination therapy); Drug: Placebo matching for Selinexor (continuous therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014

    Measured: From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)

  2. Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014

    Measured: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)

Secondary outcomes (13)

  1. Phase 2: Progression-free Survival: Based on Lugano Criteria 2014

    Measured: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)

  2. Phase 2: Overall Survival (OS)

    Measured: From date of initial randomization until death (maximum of 5 years from randomization)

  3. Phase 3: Overall Response Rate: Based on Lugano Criteria 2014

    Measured: From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)

  4. Phase 3: Overall Survival

    Measured: From date of initial randomization until death (maximum of 5 years from randomization)

  5. Phase 2: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Lugano Criteria 2014

    Measured: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy

  6. Phase 2: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria

    Measured: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy

  7. Phase 2: Duration of Response (DOR): Based on Lugano Criteria 2014

    Measured: From time of first response until disease progression or death (maximum of 5 years from randomization)

  8. Phase 2: Number of Patients with Adverse Events (AEs)

    Measured: Up to 30 days after last dose of study drug (maximum of 5 years from randomization)

  9. Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Lugano Criteria 2014

    Measured: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy

  10. Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria

    Measured: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy

  11. Phase 3: Duration of Response: Based on Lugano Criteria 2014

    Measured: From time of first response until disease progression or death (maximum of 5 years from randomization)

  12. Phase 3: Progression-free Survival: Based on Modified Lugano Criteria

    Measured: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)

  13. Phase 3: Number of Patients with Adverse Events

    Measured: Up to 30 days after last dose of study drug (maximum of 5 years from randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2020
  2. Study start3 Sep 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
501 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04442022
Sponsor's protocol ID
XPORT-DLBCL-030
Other IDs
2020-000605-84
Status last verified
Sep 2026
First submitted
10 Jun 2020
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Selinexor (combination therapy), Rituximab (combination therapy) and Gemcitabine (combination therapy) in people with Relapsed/Refractory Diffuse Large B-cell Lymphoma, run by Karyopharm Therapeutics Inc at 38 sites in 6 countries.

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 22 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Italy, Poland, China, Spain and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014 (time frame: From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04442022.

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 2 Oct 2026.

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