PCNSLReWIPretroNCT05782374
Real World Data on Ibrutinib Use in PCNSL Rel/Ref
An observational study of PCNSL, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
PCNSL is a rare and aggressive subtype of B lymphoma that has been recognized as a distinct disease entity in the latest edition of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissue and is defined as DLBCL that develops exclusively in the brain parenchyma, spinal cord, leptomeninges and eye. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PCNSL
- What is being tested?
- Ibrutinib
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 10 Aug 2022to 10 Aug 2026
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with relapsed or refractory PCNSL who in the period between August 2020 and May 2022 were candidates for treatment with ibrutinib alone or in combination with R-CHOP or R-CHOP like (in compassionate use, or off- label).
Who may be able to join
- Histological or cytological diagnosis of DLBCL
- Disease localized exclusively in the CNS (brain, meninges, cranial nerves, eyes and / or spinal cord) both at first diagnosis and at failure
- Progressive or recurrent disease
- Previous treatment with high-dose methotrexate-based chemotherapy ± WBRT
- Age 18 - 80 years
- ECOG performance status 0-3
- Adequate hematopoiesis (platelets> 25,000 / mm3, hemoglobin> 8 g / dL, ANC> 1,000 / mm3), renal (serum creatinine <2 times UNL and creatinine clearance ≥40 mL / min), cardiac (VEF ≥50% ) and liver function (SGOT / SGPT <3 times UNL, bilirubin and alkaline phosphatase <2 times UNL).
- Patients who have been given treatment with ibrutinib, alone or in combination with immunochemotherapy, and who have or have not received the same.
Who cannot join
- Patients with concomitant extra-CNS disease at presentation or relapse
- Symptomatic coronary heart disease, cardiac arrhythmias not well controlled with drugs, or myocardial infarction within the past 6 months (New York Heart Association class III or IV heart disease)
- Any other serious medical condition that could compromise the patient's ability to adhere to treatment.
- Presence of any psychological, family, sociological or geographical condition that may hinder compliance with the study protocol and the follow-up program.
- In therapy with strong CYP3A inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studio Osservazionale Retrospettivo Multicentrico Sull'Utilizzo di Ibrutinib in Monoterapia o in Associazione a Immunochemioterapia Secondo Schema R-CHOP in Pazienti Adulti Con Diagnosi di PCNSL Ricaduto o Refrattario
PCNSL is a rare and aggressive subtype of B lymphoma that has been recognized as a distinct disease entity in the latest edition of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissue and is defined as DLBCL that develops exclusively in the brain parenchyma, spinal cord, leptomeninges and eye. In patients under 70 years of age without severe comorbidities, first-line treatment with induction chemo-immunotherapy according to the MATRix scheme (Methotrexate, Cytarabine, Tiothepa, Rituximab) and subsequent consolidation with HDCT followed by ASCT achieved the best results in terms of PFS and OS. Data on patients enrolled in a randomized phase 2 study showed an OS of 70% at a median FU of 88 months. In patients> 70 years of age or with low KPS, the prognosis remains significantly lower in the younger population. Several population studies have shown a stable increase over the past 30 years in terms of PFS and OS in patients aged under 70 years, while in patients over 70 years or with KPS <70%, the survival curves are not satisfactory. in part because these patients are often referred to BSC alone, despite the benefit in PFS and OS demonstrated with HD-MTX-based treatments (≥1 g / m2) combined with oral alkylating agents or cytarabine in high doses.
Read the detailed description
Historically, HDCT followed by ASCT has not been considered a feasible option for elderly patients, although recent data collected in the "real life" setting and a pilot study conducted in Germany demonstrate that maintenance of the dose intensity of HD-MTX and treatment completion with HDCT / ASCT-based consolidation are similar to those in clinical studies. However, 20 to 50% of newly diagnosed PCNSL patients do not achieve a complete response with currently available treatment regimens, highlighting the need for improved induction strategies. Furthermore, even after a complete response, patients with PCNSL may experience relapse, especially in the elderly. First-line treatment failure usually occurs (70-75% of cases) within the first two years and the prognosis of this population is extremely poor as demonstrated in a retrospective study of more than 250 patients with PCNSL R / R who reported median PFS and OS at first relapse / progression of 2.2 and 3.5 months, respectively. Similar results have also been highlighted in several prospective studies in which the PFS and OS curves are equivalent. There is currently no standard of treatment for the treatment of patients with PCNSL R/R. Data extrapolated from the long-term FU of a randomized phase 2 trial suggests that patients with relapses more than 36 months after the end of first-line methotrexate-based immuno-chemotherapy could benefit from a rechallenge with the same treatment. On the other hand, for patients refractory or with relapses within 36 months or not eligible for HD-MTX, the best therapeutic choice is represented by enrollment in a clinical trial. In the absence of this option, the therapeutic choice is based on the experience of phase 2 studies.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
ibrutinib alone or in combination with R-CHOP or R-CHOP like
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with r/r PCNSL | Adult patients diagnosed with relapsed or refractory PCNSL who in the period between August 2020 and May 2022 were candidates for treatment with ibrutinib alone or in combination with R-CHOP or R-CHOP like (in compassionate use, or off- label). Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy in terms of overall rate of responses in patients treatment
To evaluate the efficacy in terms of overall rate of responses to treatment (ORR = sum of complete responses [CR] + partial responses [PR]) according to the IPCG 2005 criteria in a retrospective cohort of patients with relapsed / refractory PCNSL undergoing treatment with ibrutinib given as monotherapy or in combination with R-CHOP immuno-chemotherapy.
Measured: 6MONTH
Secondary outcomes (5)
Evaluate the effectiveness in terms of overall survival (OS);
Evaluate the overall survival (OS) after the treatment
Measured: 6MONTH
Evaluate the effectiveness in terms of progression-free survival (PFS);
Verify the no progression of the lymphoma after the treatment
Measured: 6MONTH
Verification of the safety of the ibrutinib monotherapy and in combination with R-CHOP
To evaluate the safety of ibrutinib administered alone and in combination with R-CHOP in the PCNSL R / R patient population;
Measured: 6MONTH
To evaluate the role of consolidation therapy with high-dose chemotherapy
To evaluate the role of consolidation therapy with high-dose chemotherapy and autologous transplant or radiotherapy (ASCT or RT) and of ibrutinib maintenance therapy;
Measured: 6MONTH
Frequency of invasive fungal infections after prophylactic antifungal therapy
Assess the frequency of invasive fungal infections and the effectiveness of prophylactic antifungal therapy in the patients treated with R-CHOP
Measured: 6MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start10 Aug 2022
- Primary completion10 Jan 2023
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PCNSLStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés José Maria Ferreri, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782374
- Sponsor's protocol ID
- OSR REWIP
- Acronym
- ReWIPretro
- Status last verified
- Jan 2026
- First submitted
- 24 Aug 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.
PubMed 34185076Ferreri AJM, Cwynarski K, Pulczynski E, Fox CP, Schorb E, Celico C, Falautano M, Nonis A, La Rosee P, Binder M, Fabbri A, Ilariucci F, Krampera M, Roth A, Hemmaway C, Johnson PW, Linton KM, Pukrop T, Gorlov JS, Balzarotti M, Hess G, Keller U, Stilgenbauer S, Panse J, Tucci A, Orsucci L, Pisani F, Zanni M, Krause SW, Schmoll HJ, Hertenstein B, Rummel M, Smith J, Thurner L, Cabras G, Pennese E, Ponzoni M, Deckert M, Politi LS, Finke J, Ferranti A, Cozens K, Burger E, Ielmini N, Cavalli F, Zucca E, Illerhaus G; IELSG32 study investigators. Long-term efficacy, safety and neurotolerability of MATRix regimen followed by autologous transplant in primary CNS lymphoma: 7-year results of the IELSG32 randomized trial. Leukemia. 2022 Jul;36(7):1870-1878. doi: 10.1038/s41375-022-01582-5. Epub 2022 May 13.
PubMed 35562406Schorb E, Fox CP, Kasenda B, Linton K, Martinez-Calle N, Calimeri T, Ninkovic S, Eyre TA, Cummin T, Smith J, Yallop D, De Marco B, Krampera M, Trefz S, Orsucci L, Fabbri A, Illerhaus G, Cwynarski K, Ferreri AJM. Induction therapy with the MATRix regimen in patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system - an international study of feasibility and efficacy in routine clinical practice. Br J Haematol. 2020 Jun;189(5):879-887. doi: 10.1111/bjh.16451. Epub 2020 Jan 29.
PubMed 31997308Kaji FA, Martinez-Calle N, Bishton MJ, Figueroa R, Adlington J, O'Donoghue M, Smith S, Byrne P, Paine S, Sovani V, Auer D, James E, Bessell EM, Grainge MJ, Fox CP. Improved survival outcomes despite older age at diagnosis: an era-by-era analysis of patients with primary central nervous system lymphoma treated at a single referral centre in the United Kingdom. Br J Haematol. 2021 Nov;195(4):561-570. doi: 10.1111/bjh.17747. Epub 2021 Aug 8.
PubMed 34368948Sieg N, Naendrup JH, Godel P, Balke-Want H, Simon F, Deckert M, Gillessen S, Kreissl S, Brockelmann PJ, Borchmann P, von Tresckow B, Heger JM. Treatment patterns and disease course of previously untreated Primary Central Nervous System Lymphoma: Feasibility of MTX-based regimens in clinical routine. Eur J Haematol. 2021 Aug;107(2):202-210. doi: 10.1111/ejh.13639. Epub 2021 May 26.
PubMed 33960535
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Osservazionale Retrospettivo Multicentrico Sull'Utilizzo di Ibrutinib in Monoterapia o in Associazione a Immunochemioterapia Secondo Schema R-CHOP in Pazienti Adulti Con Diagnosi di PCNSL Ricaduto o Refrattario
- ClinicalTrials.gov ID
- NCT05782374
- Acronym / sponsor ID
- ReWIPretro / OSR REWIP
- Conditions
- PCNSL
- Keywords
- PCNSL, R-CHOP
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 23 Mar 2023 (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.
PCNSL is a rare and aggressive subtype of B lymphoma that has been recognized as a distinct disease entity in the latest edition of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissue and is defined as DLBCL that develops exclusively in the brain parenchyma, spinal cord, leptomeninges and eye. In patients under 70 years of age without severe comorbidities, first-line treatment with induction chemo-immunotherapy according to the MATRix scheme (Methotrexate, Cytarabine, Tiothepa, Rituximab) and subsequent consolidation with HDCT followed by ASCT achieved the best results in terms of PFS and OS. Data on patients enrolled in a randomized phase 2 study showed an OS of 70% at a median FU of 88 months. In patients> 70 years of age or with low KPS, the prognosis remains significantly lower in the younger population. Several population studies have shown a stable increase over the past 30 years in terms of PFS and OS in patients aged under 70 years, while in patients over 70 years or with KPS <70%, the survival curves are not satisfactory. in part because these patients are often referred to BSC alone, despite the benefit in PFS and OS demonstrated with HD-MTX-based treatments (≥1 g / m2) combined with oral alkylating agents or cytarabine in high doses.
Detailed description
Historically, HDCT followed by ASCT has not been considered a feasible option for elderly patients, although recent data collected in the "real life" setting and a pilot study conducted in Germany demonstrate that maintenance of the dose intensity of HD-MTX and treatment completion with HDCT / ASCT-based consolidation are similar to those in clinical studies. However, 20 to 50% of newly diagnosed PCNSL patients do not achieve a complete response with currently available treatment regimens, highlighting the need for improved induction strategies. Furthermore, even after a complete response, patients with PCNSL may experience relapse, especially in the elderly. First-line treatment failure usually occurs (70-75% of cases) within the first two years and the prognosis of this population is extremely poor as demonstrated in a retrospective study of more than 250 patients with PCNSL R / R who reported median PFS and OS at first relapse / progression of 2.2 and 3.5 months, respectively. Similar results have also been highlighted in several prospective studies in which the PFS and OS curves are equivalent. There is currently no standard of treatment for the treatment of patients with PCNSL R/R. Data extrapolated from the long-term FU of a randomized phase 2 trial suggests that patients with relapses more than 36 months after the end of first-line methotrexate-based immuno-chemotherapy could benefit from a rechallenge with the same treatment. On the other hand, for patients refractory or with relapses within 36 months or not eligible for HD-MTX, the best therapeutic choice is represented by enrollment in a clinical trial. In the absence of this option, the therapeutic choice is based on the experience of phase 2 studies.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with r/r PCNSL | – | Drug: IbrutinibAdult patients diagnosed with relapsed or refractory PCNSL who in the period between August 2020 and May 2022 were candidates for treatment with ibrutinib alone or in combination with R-CHOP or R-CHOP like (in compassionate use, or off- label). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with relapsed or refractory PCNSL who in the period between August 2020 and May 2022 were candidates for treatment with ibrutinib alone or in combination with R-CHOP or R-CHOP like (in compassionate use, or off- label).
Key inclusion criteria (8 listed)
- Histological or cytological diagnosis of DLBCL
- Disease localized exclusively in the CNS (brain, meninges, cranial nerves, eyes and / or spinal cord) both at first diagnosis and at failure
- Progressive or recurrent disease
- Previous treatment with high-dose methotrexate-based chemotherapy ± WBRT
- Age 18 - 80 years
Key exclusion criteria (5 listed)
- Patients with concomitant extra-CNS disease at presentation or relapse
- Symptomatic coronary heart disease, cardiac arrhythmias not well controlled with drugs, or myocardial infarction within the past 6 months (New York Heart Association class III or IV heart disease)
- Any other serious medical condition that could compromise the patient's ability to adhere to treatment.
- Presence of any psychological, family, sociological or geographical condition that may hinder compliance with the study protocol and the follow-up program.
- In therapy with strong CYP3A inhibitors
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 |
|---|---|---|
| Ibrutinibibrutinib alone or in combination with R-CHOP or R-CHOP like | Drug | Patients diagnosed with r/r PCNSL |
Primary outcome
To evaluate the efficacy in terms of overall rate of responses in patients treatment
Time frame: 6MONTH
To evaluate the efficacy in terms of overall rate of responses to treatment (ORR = sum of complete responses [CR] + partial responses [PR]) according to the IPCG 2005 criteria in a retrospective cohort of patients with relapsed / refractory PCNSL undergoing treatment with ibrutinib given as monotherapy or in combination with R-CHOP immuno-chemotherapy.
5 secondary outcomes
Evaluate the effectiveness in terms of overall survival (OS);
Time frame: 6MONTH
Evaluate the effectiveness in terms of progression-free survival (PFS);
Time frame: 6MONTH
Verification of the safety of the ibrutinib monotherapy and in combination with R-CHOP
Time frame: 6MONTH
To evaluate the role of consolidation therapy with high-dose chemotherapy
Time frame: 6MONTH
Frequency of invasive fungal infections after prophylactic antifungal therapy
Time frame: 6MONTH
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 3 Feb 2026.
- Background: PubMed 34185076Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.
- Background: PubMed 35562406Ferreri AJM, Cwynarski K, Pulczynski E, Fox CP, Schorb E, Celico C, Falautano M, Nonis A, La Rosee P, Binder M, Fabbri A, Ilariucci F, Krampera M, Roth A, Hemmaway C, Johnson PW, Linton KM, Pukrop T, Gorlov JS, Balzarotti M, Hess G, Keller U, Stilgenbauer S, Panse J, Tucci A, Orsucci L, Pisani F, Zanni M, Krause SW, Schmoll HJ, Hertenstein B, Rummel M, Smith J, Thurner L, Cabras G, Pennese E, Ponzoni M, Deckert M, Politi LS, Finke J, Ferranti A, Cozens K, Burger E, Ielmini N, Cavalli F, Zucca E, Illerhaus G; IELSG32 study investigators. Long-term efficacy, safety and neurotolerability of MATRix regimen followed by autologous transplant in primary CNS lymphoma: 7-year results of the IELSG32 randomized trial. Leukemia. 2022 Jul;36(7):1870-1878. doi: 10.1038/s41375-022-01582-5. Epub 2022 May 13.
- Background: PubMed 31997308Schorb E, Fox CP, Kasenda B, Linton K, Martinez-Calle N, Calimeri T, Ninkovic S, Eyre TA, Cummin T, Smith J, Yallop D, De Marco B, Krampera M, Trefz S, Orsucci L, Fabbri A, Illerhaus G, Cwynarski K, Ferreri AJM. Induction therapy with the MATRix regimen in patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system - an international study of feasibility and efficacy in routine clinical practice. Br J Haematol. 2020 Jun;189(5):879-887. doi: 10.1111/bjh.16451. Epub 2020 Jan 29.
- Background: PubMed 34368948Kaji FA, Martinez-Calle N, Bishton MJ, Figueroa R, Adlington J, O'Donoghue M, Smith S, Byrne P, Paine S, Sovani V, Auer D, James E, Bessell EM, Grainge MJ, Fox CP. Improved survival outcomes despite older age at diagnosis: an era-by-era analysis of patients with primary central nervous system lymphoma treated at a single referral centre in the United Kingdom. Br J Haematol. 2021 Nov;195(4):561-570. doi: 10.1111/bjh.17747. Epub 2021 Aug 8.
- Background: PubMed 33960535Sieg N, Naendrup JH, Godel P, Balke-Want H, Simon F, Deckert M, Gillessen S, Kreissl S, Brockelmann PJ, Borchmann P, von Tresckow B, Heger JM. Treatment patterns and disease course of previously untreated Primary Central Nervous System Lymphoma: Feasibility of MTX-based regimens in clinical routine. Eur J Haematol. 2021 Aug;107(2):202-210. doi: 10.1111/ejh.13639. Epub 2021 May 26.
- Individual participant dataSharing planned: Undecided
Related trials for PCNSL
RecruitingPhase 1
Phase Ib Clinical Study of Keynatinib
Lymphoma, B-Cell
RecruitingPhase 3
IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Relapsed/Refractory Primary Central Nervous System Lymphoma
RecruitingPhase 1
Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL
Lymphoma, Primary Central Nervous System Lymphoma
Not yet recruitingPhase 2
Glofitamab Plus Gemcitabine and Oxaliplatin (GemOx) in Relapsed or Refractory Primary and Secondary Central Nervous System Lymphoma
PCNSL (Primary CNS Lymphoma), Central Nervous System Lymphoma
RecruitingPhase 1/2
Pembrolizumab, Ibrutinib and Rituximab in PCNSL
Primary Central Nervous System Lymphoma, Recurrent Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCNSL, run by IRCCS San Raffaele at 1 site in Italy.
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 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. 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 Italy. 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.
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?
To evaluate the efficacy in terms of overall rate of responses in patients treatment (time frame: 6MONTH). 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 NCT05782374, which also lists 5 linked publications.
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 3 Feb 2026.