AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 3NCT03379727

Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.

A Phase 3 study testing Midostaurin, Cytarabine and anthracycline ((daunorubicin or idarubicin): Induction Phase only in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 86 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who were eligible for standard induction and consolidation Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Midostaurin, Cytarabine and anthracycline ((daunorubicin or idarubicin): Induction Phase only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
86 sitesin 15 countries
Study dates
13 Feb 2018to 9 Jul 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients eligible for inclusion in this study have to meet all of the following criteria:
  • Written informed consent must be obtained prior to any screening procedures.
  • Patients must be 18 years of age or older at the time of signing informed consent.
  • Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification. A bone marrow or blood blast count of ≥ 20% is required, except for AML with t(15;17), t(8;21), inv(16) or t(16;16) where blast count may be <20%, and, excluding M3 (acute promyelocytic leukemia).
  • Patients with secondary AML are eligible, e.g. patients with antecedent history of treatment for prior malignancy. AML patients with a history of antecedent treatment for myelodysplasia (MDS), e.g. azacitidine or decitabine, remain eligible for treatment on this study. These agents must have been discontinued for a period of at least 30 days or 5 half-lives of the drug (whichever is greater) before midostaurin can be administered.
  • Patients must have started "7+3" or "5+2" first induction chemotherapy regimen.
Show all 13Show fewer
  • Patients must have a documented FLT3 mutation (ITD or TKD).).
  • Patients must have an ECOG Performance Status of ≤ 2
  • Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
  • Patients must have Total Bilirubin ≤ 2.5 x ULN
  • Patients must have Serum Creatinine ≤ 2.5 x ULN
  • Patients must be able to communicate well with the investigator to understand and comply with the requirements of the study
  • Women of child-bearing potential must have a negative pregnancy test before starting use of midostaurin.

Who cannot join

  • Patients eligible for this study must not meet any of the following criteria:
  • Prior therapy for AML with the following exceptions:
  • emergency leukapheresis
  • emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 7 days
  • cranial RT for CNS leukostasis (one dose only)
  • growth factor/cytokine support
Show all 21Show fewer
  • Patients with LVEF less than 45% (by echocardiogram or MUGA) or symptomatic congestive heart failure (Class III or IV) according to New York Heart Association (NYHA) classification
  • Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolved to ≤ Grade 1 within screening timeframe)
  • Patients with any uncontrolled illness, including, but not limited to, acute or chronic pancreatitis or uncontrolled infection
  • QTc >470 msec on screening ECG.
  • History of hypersensitivity to any drugs or metabolites of similar chemical classes as the study treatment.
  • Participation in a prior investigational interventional (drug) study with administration of the investigational product within 30 days or 5 half-lives of the investigational product, whichever is longer.
  • Pregnancy statements and contraception requirements:
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 4 months after stopping medication. Highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
  • Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject
  • Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
  • In case of use of oral contraception women should also add a barrier method of contraception, particularly as it is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives.
  • Sexually-active males unless they use a condom during intercourse with females of reproductive potential or pregnant women and for at least 4 months after stopping treatment to avoid conception or embryo-fetal harm.
  • Patients enrolled in this study are not permitted to participate in additional parallel study drug or device studies.

Trial locations and contacts

86 sites in 15 countries.

86 sites in 15 countries

Italy36 sites

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Avellino, AV, 83100

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Cosenza, CS, 87100

  • Novartis Investigative Site

    Cuneo, CN, 12100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Latina, LT, 04100

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Naples, 80132

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Perugia, PG, 06100

  • Novartis Investigative Site

    Pescara, PE, 65124

  • Novartis Investigative Site

    Piacenza, PC, 29100

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Salerno, SA, 84131

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Torino, TO, 10128

  • Novartis Investigative Site

    Venezia, VE, 30174

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

France16 sites

  • Novartis Investigative Site

    Bayonne, Bayonne Cedex, 64109

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Clamart, 92141

  • Novartis Investigative Site

    Créteil, 94010

  • Novartis Investigative Site

    Dijon, 21034

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Limoges, 87042

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Metz, 57085

  • Novartis Investigative Site

    Nice, 06202

  • Novartis Investigative Site

    Paris, 75012

  • Novartis Investigative Site

    Paris, 75475

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Poitiers, 86000

  • Novartis Investigative Site

    Saint Priest En Jarez, Pays de la Loire Region, 42270

  • Novartis Investigative Site

    Villejuif, 94800

Other trials in France

Spain11 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08026

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35010

  • Novartis Investigative Site

    León, 24080

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07120

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Valencia, 46026

  • Novartis Investigative Site

    Vitoria-Gasteiz, Basque Country, 01009

Other trials in Spain

Bulgaria4 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, 1413

  • Novartis Investigative Site

    Sofia, 1756

  • Novartis Investigative Site

    Varna, 9000

Other trials in Bulgaria

Finland3 sites

  • Novartis Investigative Site

    Helsinki, FIN 00290

  • Novartis Investigative Site

    Oulu, FIN-90220

  • Novartis Investigative Site

    Tampere, 33521

Other trials in Finland

Slovakia3 sites

  • Novartis Investigative Site

    Banská Bystrica, 975 17

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 833 10

  • Novartis Investigative Site

    Bratislava, 85107

Other trials in Slovakia

Czechia2 sites

  • Novartis Investigative Site

    Brno, 625 00

  • Novartis Investigative Site

    Prague, 100 34

Other trials in Czechia

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1085

  • Novartis Investigative Site

    Szeged, H 6725

Other trials in Hungary

Romania2 sites

  • Novartis Investigative Site

    Craiova, 200136

  • Novartis Investigative Site

    Iași, 700483

Other trials in Romania

Sweden2 sites

  • Novartis Investigative Site

    Borås, 501 82

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Croatia1 site

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Estonia1 site

  • Novartis Investigative Site

    Tallinn, 13419

Other trials in Estonia

Lithuania1 site

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Norway1 site

  • Novartis Investigative Site

    Bergen, 5021

Other trials in Norway

Serbia1 site

  • Novartis Investigative Site

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: An Open-label, Multi-Center, Phase IIIb Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia Who Are Eligible for "7+3" or "5+2" Chemotherapy

The purpose of this study was to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who were eligible for standard induction and consolidation

Read the detailed description

This Phase IIIb study was designed as a single arm study and allowed the assessment of variation of the "7+3" regimen in an extended patient population compared to RATIFY (higher dose of daunorubicin (60-90 mg/m2/day), the substitution of daunorubicin by idarubicin (12mg/m2/day), and lower dose of cytarabine (100-200 mg/m2/day) and the "5+2" reduced dose regimen). Safety was the primary endpoint. Complete Response (CR)/Complete remission with incomplete hematological recovery (CRi) in induction, consolidation and maintenance therapy was collected as secondary endpoint.

Patients who were newly diagnosed with AML, had a known FLT3 ITD (Internal tandem duplication) or TKD (Tyrosine kinase domain)(, mutation and had recently started on "7+3" or "5+2" in induction and high dose of cytarabine in consolidation were consented and screened for the clinical study.

.

The protocol treatment allowed the following treatment phases:

  • Induction Phase: cytarabine with anthracycline (idarubicin or daunorubicin) sequentially per HCP choice, followed by midostaurin on day 8. In the first Induction phase, a bone marrow aspiration was performed in all subjects on Days 21- 28 (according to local standard of care) to determine the need for a second induction cycle. If the marrow aspirate was inadequate to make a determination, the bone marrow assessment was repeated within one week. If the Day 21-28 (according to local standard of care) bone marrow aspiration reveals ≥ 5% leukemic blasts in a cellular marrow (> 20%) a second induction was given. For subjects requiring a second induction, treatment began at least 3 days after completing midostaurin. Bone marrow aspiration was performed within one week after recovery of ANC ≥ 1000/μL and platelets ≥ 100,000/μL to assess for response. Subjects in CR proceeded to consolidation therapy. Subjects not achieving a marrow remission (or with persistent blasts) were to be removed from protocol therapy. Subjects with CRi proceeded to consolidation therapy as per investigator's discretion. 1 or 2 cycles of "7+3" or "5+2" regimens (switching between regimens was not allowed).
  • Consolidation Phase (for subjects in CR/CRi after consolidation therapy) (up to four cycles of cytarabine consolidation per investigator's discretion, with midostaurin given sequentially during each cycle): Based upon the superior results reported for AML subjects less than 60 years old with normal karyotypes in prospective clinical trials and RATIFY, who achieved a CR/CRi after induction received further therapy with midostaurin. Subjects received up to four cycles of consolidation therapy. Each consolidation cycle was four weeks in duration, and was to begin within two weeks following hematologic recovery (ANC ≥ 1000/μL, platelet count ≥ 100,000/μL), but not sooner than 31 days from the beginning of the previous cycle. A bone marrow aspiration was to be performed prior to the first consolidation cycle (C1D1) and later could be performed if necessary per investigator's decision at any time during Consolidation Phase.
  • Maintenance Phase (for subjects in CR/CRi after consolidation therapy): Subjects who continued in CR/CRi (by bone marrow aspiration and blood evaluation) after four cycles of consolidation therapy received midostaurin. Prior to maintenance therapy, all significant acute toxicity from consolidation therapy was to be resolved to ≤ grade 2. Subjects with CRi proceeded to maintenance therapy as per investigator's discretion and for CR subjects maintenance therapy began after hematologic recovery (ANC ≥ 1000/μL, platelet count ≥ 100,000/μL) from remission consolidation, and at least 3 days after the last dose of midostaurin during consolidation. Subjects who were unable to complete four courses of HiDAC consolidation because of toxicity could still be eligible for maintenance therapy at the discretion of the principal investigator after the last dose of consolidation after recovery from hematologic and other significant acute toxicity. A bone marrow examination was to be performed prior to the first maintenance and every 3 months during Maintenance phase. Maintenance phase was up to 12 cycles of maintenance therapy with single-agent midostaurin or until relapse, unacceptable toxicity, or death, physician's decision, subject/guardian's decision, protocol deviation, study termination by sponsor, lost to follow-up, technical problems, pregnancy, subject withdrew consent or until the end of study, whichever event occured first.
Being tested
Midostaurin, Cytarabine, anthracycline ((daunorubicin or idarubicin): Induction Phase only
Keywords
Midostaurin, PKC412, FMS-like tyrosine kinase receptor, FLT3, Acute Myeloid Leukemia, AML, 7+3 chemotherapy, 5+2 chemotherapy, Daunorubicin, Idarubicin, Cytarabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • MidostaurinDrug

    Also called PKC412

    Induction Phase: 50 mg (two 25 mg capsules) twice a day by mouth on days 8-28, for 1 - 2 cycles; a cycle = 28 days; Consolidation Phase: 50 mg (two 25 mg capsules) twice a day by mouth on days 8-28, for up to 4 cycles; Maintenance Phase: Continuous dosing (days 1 - 28) for up yo 12 cycles or until relapse, unacceptable toxicity, death, physician's decision, subject/guardian decision, protocol deviation, study termination by Sponsor, lost to follow-up, technical problems, pregnancy, subject withdrew consent, or until the end of study, whichever event occurred first.

  • CytarabineDrug

    Induction Phase (standard dose) (7 + 3 arm): 100-200 mg/m2/day by Continuous intravenous infusion (CIVI) days 1-7 (168 hours infusion); Induction Phase (5 + 2 arm): 100 mg/m2/day by CIVI days 1-5; Consolidation Phase: 1-3 g/m2 infusion over 3 hours every 12 h on days 1, 3 and 5, up to 4 cycles based on age and per investigator discretion

  • anthracycline ((daunorubicin or idarubicin): Induction Phase onlyDrug

    daunorubicin (7 + 3 arm): 60-90 mg/m2/day by IV push on days 1-3 (with standard-dose cytarabine); daunorubicin (5 + 2 arm): 60 mg/m2/day by IV push on days 1-2; idarubicin (7 + 3 arm): 12 mg/m2/day by IV push on days 1-3 (with standard-dose cytarabine); idarubicin (5 + 2 arm): 12 mg/m2/day by IV push on days 1-2

Study groups in NCT03379727
Study groupRoleWhat they receive
MidostaurinExperimentalPatients went through 3 phases: Induction phase - Day (D)8 to D28 in combination with standard of care (7+3 or 5+2 chemotherapy) up to 2 cycles; Consolidation phase - D8 to D28 in combination with cytarabine up to 4 cycles; Maintenance phase - D1 to D28 up to 12 cycles
Receives: Drug: Midostaurin; Drug: Cytarabine; Drug: anthracycline ((daunorubicin or idarubicin): Induction Phase only

What is being measured

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

  1. Percentage of Patients With Adverse Events (AEs), Grade 3 & 4 AEs, Serious Adverse Events (SAEs), AEs Leading to Discontinuation, and Deaths up to 24 Months (M24).

    Safety of Midostaurin was represented by various types of AEs, SAEs \& death up to M24. AE: the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained. AE grades to characterize the severity of AEs were based on the Common Terminology Criteria for AEs ver. 4.03 with Grade (Gr) 1: mild; Gr 2: moderate; Gr 3: severe; Gr 4: life-threatening; Gr 5: death related to AE. AEs not related to hematological toxicities were generally of grade 1 or 2 severity. SAE: 1 of the following: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, i.e. an event that jeopardizes the patient or may require medical or surgical intervention to prevent 1 of the outcomes listed above, requires inpatient hospitalization or prolongation of existing hospitalization with a few exceptions.

    Measured: Baseline up to approximatly 24 months

Secondary outcomes (1)

  1. Percentage of Patients With Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (CRi) as Per Local Assessment

    CR/CRi rate is defined as the percentage of patients with complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) as per local assessment in Induction, Consolidation and Maintenance phases. CR/CRi rate was calculated based on the full analysis set (FAS).

    Complete remission (CR): Bone marrow blasts <5% with spicules; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) >1.0 x109/L; platelet count >100 x 109/L; independence of red cell transfusions.

    CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia (<1.0 x109/L) or thrombocytopenia (<100 x 109/L)

    Measured: Baseline up to approximately 24 months

Timeline

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

  1. First posted20 Dec 2017
  2. Study start13 Feb 2018
  3. Primary completion9 Jul 2021
  4. Study completion9 Jul 2021

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03379727
Sponsor's protocol ID
CPKC412A2408
Other IDs
2016-004440-12, 2016
Status last verified
Feb 2024
First submitted
14 Dec 2017
Last updated
29 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Sierra J, Montesinos P, Thomas X, Griskevicius L, Cluzeau T, Caillot D, Legrand O, Minotti C, Luppi M, Farkas F, Bengoudifa BR, Gilotti G, Hodzic S, Rambaldi A, Venditti A. Midostaurin plus daunorubicin or idarubicin for young and older adults with FLT3-mutated AML: a phase 3b trial. Blood Adv. 2023 Nov 14;7(21):6441-6450. doi: 10.1182/bloodadvances.2023009847.

    PubMed 37581981

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Midostaurin, Cytarabine and anthracycline ((daunorubicin or idarubicin): Induction Phase only in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 86 sites in 15 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 13 inclusion and 21 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: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Italy, France, Spain, Bulgaria, Finland and 10 more countries. 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 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?

Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients With Adverse Events (AEs), Grade 3 & 4 AEs, Serious Adverse Events (SAEs), AEs Leading to Discontinuation, and Deaths up to 24 Months (M24). (time frame: Baseline up to approximatly 24 months). 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 NCT03379727, which also lists 1 linked publication.

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 29 Feb 2024.

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