AzTrials
AzTrials

Chronic Myeloid Leukemia in RemissionPhase 3ENDURE-CML-IXNCT03117816

ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission

A Phase 3 study testing AOP2014 / Pegylated-Proline-interferon alpha-2b and Surveillance in people with Chronic Myeloid Leukemia in Remission, run by Philipps University Marburg at 26 sites in 2 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

A randomized, open-label assessor blinded, multi-center, controlled phase III Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia in Remission
What is being tested?
AOP2014 / Pegylated-Proline-interferon alpha-2b and Surveillance
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
26 sitesin 2 countries
Study dates
4 May 2017to 12 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent form.
  • Capability and willingness to comply with study procedures and ability to self-administration of the study drug.
  • Male or female aged ≥ 18 years.
  • At least three years of TKI therapy.
  • BCR-ABL-positive, chronic phase CML patients with a transcript level according to the international scale (IS) of at least MR4, or better (MR4.5, MR5). MR4 is defined as (i) detectable disease ≤0.01% BCR-ABL IS or (ii) undetectable disease in cDNA with ≥10,000 ABL or ≥24,000 GUS transcripts for at least one year. There have to be at least three consecutive PCR-results with MR4 or better within the last year (+ months) before study entry. The latest of these PCRs must be a confirmatory MR4 measurement prior to randomization by the EUTOS-certified Study Reference Laboratories for PCR (BCR-ABL mRNA). No PCR-results in the last year before randomisation can be worse than MR4. If the last PCR was not done within two months from baseline (day 0) in an EUTOS-certified study Reference Laboratory; the PCR sample must be sent to an EUTOS-certified study Reference Laboratory at screening.
  • Patients who had failed to discontinue TKI in a prior discontinuation attempt are eligible for this protocol, if they fulfil criterion 5 after retreatment with TKI. A prior TKI discontinuation failure must be specifically indicated at inclusion and documented.
Show all 13Show fewer
  • Adequate organ function:
  • especially total bilirubin, lactate dehydrogenase [LDH], aspartate aminotransferase [AST], alanine aminotransferase [ALT] and coagulation parameters ≤ 2 × upper limit of normal (ULN)
  • Adequate hematological parameters:
  • platelet count ≥ 100 × 1000000000/L; white blood cell count ≥ 2.5 × 1000000000/L; lymphocytes ≥ 1.0 × 1000000000/L; hemoglobin ≥ 9.0 g/dL or 5.59 mmol/L.
  • Female patients with reproductive potential must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used. Male patients must agree to use condoms during study participation.
  • Negative serum pregnancy test in women of childbearing potential.
  • Date of diagnosis of CML confirmed by laboratory PCR must be known.

Who cannot join

  • Rare variants of BCR-ABL not quantifiable by RT-PCR according to the international scale (IS).
  • Current or previous autoimmune diseases requiring treatment.
  • Immunosuppressive treatment of any kind; transplant recipients
  • Prior allogeneic stem cell transplantation.
  • Prior pegylated IFN therapy. Prior low dose conventional IFN treatment with ≤ 3 x 3 Mio I.E. / week for less than 1 year is acceptable.
  • History of TKI resistance within the last 4 years of TKI therapy.
Show all 27Show fewer
  • History of accelerated phase or blast crisis.
  • Hypersensitivity/allergy to the active substance or excipients of the formulation.
  • Severe hepatic dysfunction or decompensated cirrhosis.
  • End stage renal disease (GFR <15 ml/min)
  • Thyroid disease that cannot be controlled by conventional therapy.
  • Uncontrolled diabetes mellitus
  • Epilepsy or other disorders of the central nervous system.
  • Severe cardiac disease history including unstable or uncontrolled cardiac disease in the previous 6 months.
  • Uncontrolled hypertension
  • Any history of retinopathy e.g. retinal detachment, degeneration or thromboembolic events.
  • Clinically significant concomitant diseases or conditions, which, in the opinion of the investigator, would lead to an unacceptable risk for the patient to participate in the study (please refer also to the actual Investigator Brochure).
  • Other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin, or other cancer(s) for which the patient has been disease free for more than 3 years.
  • Active or uncontrolled infections at the time of randomization.
  • Pregnant and/or nursing women.
  • Use of antibiotic therapy within the last 2 weeks prior to randomization
  • Concurrent use of molecular targeted therapy.
  • Tested HIV sero-positivity or tested active hepatitis B or C infection.
  • Participation in another clinical study with other investigational drugs within 14 days prior to randomization.
  • Vaccination within 1 month prior to randomization.
  • Any medical, mental, psychological or psychiatric condition (particularly severe depression, suicidal ideation or suicide attempt) that in the opinion of the investigator would not permit the patient to complete the study or comply to study procedures.
  • Drug and/or alcohol abuse.

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

Germany23 sites

  • 03 Universitätsklinikum Aachen, Hämatologie/Onkologie

    Aachen, 52074

  • 18 Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • 06 Universitätsmedizin Berlin Charite- Campus Virchow Klinikum, Klinik für Hämatologie und Onkologie

    Berlin, 13353

  • 19 Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III

    Bonn, 53105

  • 16 Klinikum Bremen Mitte, Medizinische Klinik I

    Bremen, 28177

  • 22 BAG / Onkologische Gemeinschaftspraxis

    Dresden, 01307

  • 05 Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

    Düsseldorf, 40225

  • 07 Universitätsklinikum Erlangen, Medizinische Klinik 5

    Erlangen, 91054

  • 20 Universitätsklinikum Essen, Klinik für Hämatologie

    Essen, 45147

  • 17 Klinikum der Goethe Universität, Medizinische Klinik II

    Frankfurt A. Main, 60590

  • 21 Universitätsklinikum Hamburg Eppendorf, Klinik für Onkologie, Hämatologie und KMT

    Hamburg, 20246

  • 23 Evangelische Krankenhaus Hamm gGmbH, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Hamm, 59063

  • 02 Universitätsklinikum Jena, linik für Innere Medizin II Abt. für Hämatologie und Internistische Onkologie

    Jena, 07740

  • 24 Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, 56068

  • 13 Universitätsklinikum Leipzig, Abteilung für Hämatologie u. Internistische Onkologie

    Leipzig, 04103

  • 14 Johannes-Gutenberg-Universität III. Medizinische Klinik

    Mainz, 55131

  • 04 Universitätsmedizin Mannheim, III. Medizinische Klinik

    Mannheim, 68169

  • 01 Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg, Klinik für Hämatologie, Onkologie und Immunologie

    Marburg, 35043

  • 10 Technische Universität München (TUM) Klinikum rechts der Isar, III. Medizinische Klinik und Poliklinik

    Munich, 81675

  • 08 Universitätsklinikum Münster, Medizinische Klinik, Innere Medizin A

    Münster, 48149

  • 09 Universitätsklinikum Tübingen, Medizinische Klinik

    Tübingen, 72076

  • 12 Universitätsklinikum Ulm, Klinik für Innere Medizin III

    Ulm, 89081

  • 15 Universitätsklinikum Würzburg, Zentrum für Innere Medizin

    Würzburg, 97080

Other trials in Germany

France3 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Léon Bérard

    Lyon, 69373

  • CHRU de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: Efficacy and Safety of Pegylated Proline Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients With Chronic Myeloid Leukemia (CML) Who Discontinue ABL-Kinase Inhibitor Therapy - a Randomized Phase III, Multicenter Trial With Post-study Follow-up

A randomized, open-label assessor blinded, multi-center, controlled phase III Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).

Read the detailed description

Four hypotheses are tested in hierarchical order. To avoid inflation of type 1 error (false rejection of a null hypothesis), further confirmatory testing has to be stopped as soon as a null hypothesis could not be rejected.

All four hypotheses are tested at significance level 0.05. Null hypothesis 1 is the primary endpoint and investigates molecular relapse-free survival as a time-to-event variable; the two arms are compared with the log-rank test. Null hypotheses 2, 3, and 4 deal with probabilities of molecular relapse-free survival 7, 13, and 25 months after randomization, respectively; arms A and B are compared with the uncorrected chi-square test.

Being tested
AOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance
Keywords
deep molecular remission of MR4 or better

What participants receive

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

  • AOP2014 / Pegylated-Proline-interferon alpha-2bDrug

    AOP2014 as pre-filled auto-injection pen for subcutaneous injection, containing 250 µg AOP2014 / 0.5 ml. The solution also contains inactive ingredients (sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, and acetic acid). The solution is colorless to light yellow.

  • SurveillanceOther

    For patients randomized into this treatment arm stopp their standard treatment and will just be under observation.

Study groups in NCT03117816
Study groupRoleWhat they receive
investigational arm AExperimentalThere will be an overlapping treatment with AOP2014 and TKI for one month. After one month, the TKI therapy will be stopped and patient will receive only AOP2014 treatment for the next 14 months.
Receives: Drug: AOP2014 / Pegylated-Proline-interferon alpha-2b
surveillance arm BOtherThis is an open-label study with a "surveillance" group as comparator arm. Similar as in the arm A, patient will discontinue TKI therapy one month after randomization. From then on patient will receive no further CML treatment.
Receives: Other: Surveillance

What is being measured

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

  1. mRFS

    The primary efficacy endpoint is molecular relapse free survival (mRFS). Relapse is defined as loss of major molecular remission, MMR, which is any increase of the BCR-ABL ratio to > 0.1% according to the international scale (IS). Time to relapse is defined as the time from randomization to relapse the BCR-ABL ratio to > 0.1% according to the international scale (IS). Time to relapse is defined as the time from randomization to relapse.

    Measured: Randomization until time of relapse

Secondary outcomes (11)

  1. mRFS 7

    The primary efficacy endpoint is molecular relapse free survival, RFS 7 months after

    Measured: 7 months after randomization

  2. mRFS 13

    The relapse free survival, RFS 13 months after randomization

    Measured: 13 months after randomization

  3. mRFS 25

    The relapse free survival, RFS 25 months after randomization

    Measured: 25 months after randomization

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

    Adverse events, serious adverse events (AEs, SAEs)• Safety, tolerability and toxicity based on incidences of adverse events, serious adverse events

    Measured: Day 0 - Month 15 (Arm B) or Month 16 (additional safety visit one month after last application for Arm A)

  5. Quality of life measured by EORTC QLQ-C30

    The QoL assessment in this study is planned to gain information on the QoL of CML patients under stopping conditions. The data will be compared between the treatment groups and to QoL of normal population.

    Measured: Day 0 - Month 25

  6. Quality of life measured by EORTC-QLQ-CML24

    The QoL assessment in this study is planned to gain information on the QoL of CML patients under stopping conditions. The data will be compared between the treatment groups and to QoL of normal population. Furthermore, results of the CML24 module should be shared with the EORTC group to complete the validation of this questionnaire

    Measured: Day 0 - Month 25

  7. OS (overall survival)

    Overall survival (OS), defined as the time between the date of randomization and the date of death from any cause.

    Measured: Day 0 - Month 25 (plus annual post study follow up Months 36,48,60)

  8. Kinetics of BCR-ABL transcript level over time after TKI stop

    Kinetics of BCR-ABL transcript level over time after TKI stop

    Measured: Day 0 - Month 25 (plus annual post study follow up Months 36,48,60)

  9. For Germany: Detection of blood parameters 95 CD86+pDC as mRFS predictor

    For Germany: To explore the value of 95 CD86+pDC / 105 lymphocytes at baseline in predicting risk of molecular relapse (loss of MMR)

    Measured: Day 0 - Month 25 (plus annual post study follow up Months 36,48,60)

  10. For Germany: Explore immunological and genetic biomarkers and identify predictors

    For Germany: Explore immunological and genetic biomarkers to study biology of TFR, and identify predictors IFN response (e.g. mRNA sequencing of whole blood or leukocyte subpopulations, PD-L1-, PD1-, CD62L- measurements by FACS on peripheral blood subsets, T-cell activation and exhaustion marker measurements, PR1-CTL assessment and cytokines). Evaluation of cytokines/chemokines (i.e., IL-6, IFN-α, IL 10, and others).

    Measured: Day 0 - Month 25 (plus annual post study follow up Months 36,48,60)

  11. For Germany: Evaluation of cytokines/chemokines

    For Germany: Evaluation of cytokines/chemokines (i.e., IL-6, IFN-α, IL 10, and others)

    Measured: Day 0 - Month 25 (plus annual post study follow up Months 36,48,60)

Timeline

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

  1. First posted18 Apr 2017
  2. Study start4 May 2017
  3. Primary completion26 Jan 2022
  4. Study completion12 Dec 2022

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03117816
Sponsor's protocol ID
KKS-227
Other IDs
2016-001030-94, 2016
Acronym
ENDURE-CML-IX
Status last verified
Mar 2023
First submitted
8 Mar 2017
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ben-Neriah Y, Daley GQ, Mes-Masson AM, Witte ON, Baltimore D. The chronic myelogenous leukemia-specific P210 protein is the product of the bcr/abl hybrid gene. Science. 1986 Jul 11;233(4760):212-4. doi: 10.1126/science.3460176.

    PubMed 3460176

  • Daley GQ, Van Etten RA, Baltimore D. Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science. 1990 Feb 16;247(4944):824-30. doi: 10.1126/science.2406902.

    PubMed 2406902

  • Perrotti D, Jamieson C, Goldman J, Skorski T. Chronic myeloid leukemia: mechanisms of blastic transformation. J Clin Invest. 2010 Jul;120(7):2254-64. doi: 10.1172/JCI41246. Epub 2010 Jul 1.

    PubMed 20592475

  • Saussele S, Lauseker M, Gratwohl A, Beelen DW, Bunjes D, Schwerdtfeger R, Kolb HJ, Ho AD, Falge C, Holler E, Schlimok G, Zander AR, Arnold R, Kanz L, Dengler R, Haferlach C, Schlegelberger B, Pfirrmann M, Muller MC, Schnittger S, Leitner A, Pletsch N, Hochhaus A, Hasford J, Hehlmann R; German CML Study Group. Allogeneic hematopoietic stem cell transplantation (allo SCT) for chronic myeloid leukemia in the imatinib era: evaluation of its impact within a subgroup of the randomized German CML Study IV. Blood. 2010 Mar 11;115(10):1880-5. doi: 10.1182/blood-2009-08-237115. Epub 2009 Nov 18.

    PubMed 19965667

  • Hochhaus A, O'Brien SG, Guilhot F, Druker BJ, Branford S, Foroni L, Goldman JM, Muller MC, Radich JP, Rudoltz M, Mone M, Gathmann I, Hughes TP, Larson RA; IRIS Investigators. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61. doi: 10.1038/leu.2009.38. Epub 2009 Mar 12.

    PubMed 19282833

  • Larson RA, Hochhaus A, Hughes TP, Clark RE, Etienne G, Kim DW, Flinn IW, Kurokawa M, Moiraghi B, Yu R, Blakesley RE, Gallagher NJ, Saglio G, Kantarjian HM. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012 Oct;26(10):2197-203. doi: 10.1038/leu.2012.134. Epub 2012 May 18.

    PubMed 22699418

  • Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boque C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

    PubMed 24311723

  • Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Muller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saussele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM, Hehlmann R. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013 Aug 8;122(6):872-84. doi: 10.1182/blood-2013-05-501569. Epub 2013 Jun 26.

    PubMed 23803709

  • Cross NC, White HE, Muller MC, Saglio G, Hochhaus A. Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia. 2012 Oct;26(10):2172-5. doi: 10.1038/leu.2012.104. Epub 2012 Apr 16.

    PubMed 22504141

  • Muller MC, Cross NC, Erben P, Schenk T, Hanfstein B, Ernst T, Hehlmann R, Branford S, Saglio G, Hochhaus A. Harmonization of molecular monitoring of CML therapy in Europe. Leukemia. 2009 Nov;23(11):1957-63. doi: 10.1038/leu.2009.168. Epub 2009 Aug 27.

    PubMed 19710700

  • Hehlmann R, Muller MC, Lauseker M, Hanfstein B, Fabarius A, Schreiber A, Proetel U, Pletsch N, Pfirrmann M, Haferlach C, Schnittger S, Einsele H, Dengler J, Falge C, Kanz L, Neubauer A, Kneba M, Stegelmann F, Pfreundschuh M, Waller CF, Spiekermann K, Baerlocher GM, Ehninger G, Heim D, Heimpel H, Nerl C, Krause SW, Hossfeld DK, Kolb HJ, Hasford J, Saussele S, Hochhaus A. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-study IV. J Clin Oncol. 2014 Feb 10;32(5):415-23. doi: 10.1200/JCO.2013.49.9020. Epub 2013 Dec 2.

    PubMed 24297946

  • Graham SM, Jorgensen HG, Allan E, Pearson C, Alcorn MJ, Richmond L, Holyoake TL. Primitive, quiescent, Philadelphia-positive stem cells from patients with chronic myeloid leukemia are insensitive to STI571 in vitro. Blood. 2002 Jan 1;99(1):319-25. doi: 10.1182/blood.v99.1.319.

    PubMed 11756187

  • Corbin AS, Agarwal A, Loriaux M, Cortes J, Deininger MW, Druker BJ. Human chronic myeloid leukemia stem cells are insensitive to imatinib despite inhibition of BCR-ABL activity. J Clin Invest. 2011 Jan;121(1):396-409. doi: 10.1172/JCI35721. Epub 2010 Dec 13.

    PubMed 21157039

  • Cortes J, O'Brien S, Kantarjian H. Discontinuation of imatinib therapy after achieving a molecular response. Blood. 2004 Oct 1;104(7):2204-5. doi: 10.1182/blood-2004-04-1335. No abstract available.

    PubMed 15377577

  • Rousselot P, Huguet F, Rea D, Legros L, Cayuela JM, Maarek O, Blanchet O, Marit G, Gluckman E, Reiffers J, Gardembas M, Mahon FX. Imatinib mesylate discontinuation in patients with chronic myelogenous leukemia in complete molecular remission for more than 2 years. Blood. 2007 Jan 1;109(1):58-60. doi: 10.1182/blood-2006-03-011239. Epub 2006 Sep 14.

    PubMed 16973963

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AOP2014 / Pegylated-Proline-interferon alpha-2b and Surveillance in people with Chronic Myeloid Leukemia in Remission, run by Philipps University Marburg at 26 sites in 2 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 27 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany, France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

mRFS (time frame: Randomization until time of relapse). 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 NCT03117816, which also lists 61 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 31 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in