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Leukemia, Lymphocytic, Chronic, B-CellPhase 1/2ENHANCENCT02406742

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 1/2 study testing CC-122, Ibrutinib and Obinutuzumab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Celgene at 24 sites in 5 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

Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with ibrutinib and obinuzutumab. CC-122 has multiple activities, including immune modulation of several immune cell subsets and antiproliferative activity in CLL. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Leukemia, Lymphocytic, Chronic, B-Cell
What is being tested?
CC-122, Ibrutinib and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
24 sitesin 5 countries
Study dates
27 Jul 2015to 7 Jul 2020
Phase
Phase 1/2
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 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects ≥ 18 years age and ≤ 80 years of age at the time of signing the informed consent form.
  • Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Must have a documented diagnosis of CLL/ SLL requiring treatment (per IWCLL guidelines). In addition:
  • Presence of at least one clinically measurable lesion: i. nodal lesion that measures ≥ 1.5 cm in longest dimension (LD) and ≥ 1.0 cm in longest perpendicular dimension (LPD), or ii. spleen that measures ≥ 14 cm in longest vertical dimension (LVD) with a minimum of 2 cm enlargement, or iii. liver that measures ≥ 20 cm in LVD with a minimum of 2 cm enlargement, or iv. peripheral blood B lymphocyte count > 5000/uL.
  • Must meet the criteria for relapsed and/or refractory disease according to the IWCLL guidelines (Hallek, 2008) to ≥ 1 prior treatment (with the exception of Arm B) and have evidence of disease progression requiring treatment at the time of study entry as follows:
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  • For Arms A and C, subjects must have received either prior chemoimmunotherapy or therapy with an approved BTK inhibitor with the following exceptions: i. Chemoimmunotherapy is not required if subjects have specific comorbidities that preclude the use of standard chemoimmunotherapy meeting at least 1 of the following criteria;
  • 1. CIRS ≥ 6; 2. Creatinine Clearance < 70 mL/min; 3. Subject is not a candidate for a chemoimmunotherapy in the opinion of investigator. ii. Treatment with an approved BTK inhibitor is not required if subject has contraindications or is not a candidate for such a therapy in the opinion of the investigator. b. For Arm B, subjects with treatment-naïve or R/R CLL must meet the following criteria: i. Dose Escalation Phase: Subjects must not have received prior treatment with ibrutinib (or any other approved BTK inhibitors) and must have either R/R CLL or treatment naïve (ie, first-line) CLL if the subject:
  • has 17p- and/or TP53 mutation; or
  • is unfit for standard chemoimmunotherapy meeting at least 1 of the following co-morbidity criteria: a. CIRS ≥ 6; b. Creatinine Clearance < 70 mL/min; c. Subject is not a candidate for a chemoimmunotherapy in the opinion of the investigator. The reason for not being a candidate must be documented in CRF. ii. Dose Expansion Phase: Subjects must not have received prior treatment with ibrutinib (or any other approved BTK inhibitors) and must have high risk CLL. High risk is defined as: 1) 17p- and/or TP53 mutation positive in treatment naïve CLL; or 2) 17p- and/or TP53 mutation positive, and/or complex karyotype, and/or progression < 24 months after completion of 1st line chemoimmunotherapy in R/R CLL c. Subjects with R/R SLL or CLL with bulky disease (at least one lymph node measuring > 5.0 cm in diameter) are considered at higher risk for developing a TFR and may only be enrolled upon discussion with the sponsor's medical monitor and agreement to close medical management.
  • 6. Subjects must have the following lab values:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 or ≥ 1000 cells/mm3 if secondary to bone marrow involvement by disease.
  • Platelet count ≥ 100,000 cells/mm3 (100 x 109/L) or ≥ 50,000 cells/mm3 (50 x 109/L) if secondary to bone marrow involvement by disease.
  • Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) < 3.0 x upper limit of normal (ULN) unless due to disease.
  • Serum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome.
  • o Serum bilirubin ≤ 1.0 x ULN unless due to Gilbert's syndrome, Treatment Arm B only (CC-122 in combination with ibrutinib)
  • Calculated creatinine clearance of ≥ 60 ml/min.
  • No evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
  • 7. ECOG PS (Eastern Cooperative Group Performance Status) of 0 or 1. 8. Ability to swallow oral capsules without difficulty. 9. Pregnancy Prevention Risk Management Plan:
  • <!-- -->
  • Females of childbearing potential (FCBP) must undergo pregnancy testing based on the frequency outlined in the Pregnancy Prevention Risk Management Plan (PPRMP) and pregnancy results must be negative.
  • Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in the PPRMP.
  • For Arm C, subjects must agree to use adequate contraceptive methods for 18 months (please refer to the obinutuzumab IB, PI, and SmPC).
  • Complete abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject.
  • Periodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
  • Males (including those who have had a vasectomy) must practice complete abstinence or use barrier contraception (condoms) when engaging in sexual activity with FCBP as specified in the PPRMP.
  • Males must agree not to donate semen or sperm for the duration of the study and for 3 months after the last dose of CC-122.
  • All subjects must:
  • Understand that the (investigational Product) IP could have a potential teratogenic risk.
  • Agree to abstain from donating blood while taking IP and following discontinuation of IP.
  • Agree not to share IP with another person.
  • Other than the subject, FCBP and males should not handle the IP or touch the capsules, unless gloves are worn.
  • Be counseled about pregnancy precautions and risks of fetal exposure.
  • ARM B ONLY:
  • 10. Enrollment into Arm B will be permitted if ibrutinib is considered the standard of care in the clinical practice.
  • EXPANSION COHORT 2 OF ARM C:
  • 11. Subjects in Cohort 2 of Arm C must meet the following criteria:
  • Subject must have received at least one BCR PI (ibrutinib, idelalisib, or other approved BTK or PI3K inhibitor) and/or venetoclax;
  • Subject must be either resistant to or intolerant of (ie., treatment failures) the last BCR PI and/or venetoclax. Resistant is defined as relapsed or refractory per
  • IWCLL2008:
  • Relapse is defined as a patient who has previously achieved a CR or PR, but after a period of 6 or more months, demonstrates evidence of disease progression. ii. Refractory is defined as failing to achieve a CR or PR, or disease progression within 6 months after initiation of treatment with an approved BTK or PI3K inhibitor (eg, ibrutinib, idelalisib) or venetoclax. iii. Intolerance is defined as the inability to continue treatment with a BCR PI or venetoclax due to toxicities or due to development of a contraindication that makes the subject ineligible to receive further treatment with a BCR PI or venetoclax.

Who cannot join

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Any condition that confounds the ability to interpret data from the study.
  • Prior autologous or allogeneic stem cell transplant (SCT)/bone marrow transplant within 12 months of signing the ICD. Subjects who received allogeneic SCT ≥ 12 months before signing the ICD may be eligible provided there is no ongoing graft-versus-host disease and no ongoing immune suppression therapy.
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection requiring parenteral antibiotics.
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  • Uncontrolled diabetes mellitus.
  • The glycemic targets for subjects with diabetes should take into consideration age, comorbidities, life expectancy, and functional status of the subjects and follow established guidelines (eg, International Diabetes Federation, the European Diabetes Working Party guidelines, and the American Diabetes Association). For younger (< 70 years old) or subjects with life expectancy ≥ 10 years, the target glycosylated hemoglobin, type A1C (HbA1c) should be < 7.0%. The target HbA1c for older (≥ 70 years old) subjects or subjects with life expectancy < 10 years should be < 8.0%. Consultation with an endocrinologist is recommended when deciding if diabetes is optimally controlled.
  • Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease). d. Active central nervous system involvement as documented by spinal fluid cytology or imaging. e. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. f. Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with protocol.
  • History of second malignancies with life expectancy of < 2 years or requirement of therapy that would confound study results. This does not include the following:
  • Basal cell carcinoma of the skin.
  • Squamous cell carcinoma of the skin.
  • Carcinoma in situ of the cervix.
  • Carcinoma in situ of the breast.
  • Carcinoma in situ of the bladder.
  • Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).
  • Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV), or hepatitis B or C virus (HBV, HCV).
  • Hepatitis B screening is mandatory for all patients (HBsAg and anti-HBc). Patients with active hepatitis B disease should not be treated with obinutuzumab. Patients should be referred to a specialist if they are carriers before treatment starts (see PI or SmPC). Subjects who are positive for anti-HBc and/or anti-HBs but negative for HBsAg and HBV DNA may be treated after consultation with a hepatologist.
  • Any peripheral neuropathy ≥ NCI CTCAE Grade 2.
  • Use of systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day.
  • Medicines with high probability to cause QT prolongation or torsades de pointes. Subjects on chronic medications in this category may enroll after discussion with the medical monitor if changing these medications are not in the best medical interest of the patient.
  • History of hypersensitivity to IMiDs® (lenalidomide, pomalidomide, thalidomide).
  • Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echocardiogram (ECHO).
  • Complete left bundle branch, or bifasicular, block.
  • Congenital long QT syndrome.
  • Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation.
  • QTcF > 470 msec on Screening ECG (mean of triplicate recordings).
  • Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting CC 122.
  • Uncontrolled congestive heart failure or uncontrolled hypertension.
  • Troponin-T value >0.4 ng/mL or BNP >300 pg/mL. Subjects with baseline troponin-T >ULN or BNP >100 pg/mL are eligible but must have cardiologist evaluation prior to enrollment in the trial for baseline assessment and optimization of cardioprotective therapy.
  • Chemotherapy, radiotherapy, investigational anticancer therapy or major surgery within 28 days of Day 1 dosing with the following exceptions:
  • Arm A: A minimum 5-day washout after discontinuation of ibrutinib therapy (or other BTK inhibitors) is required; only those subjects without rapid disease progression during the 5-day washout will be allowed to enroll into Arm A.
  • Rapid disease progression is defined as follows:
  • 1. For subjects with measurable nodal disease, the increase in the sum of diameters of the largest lymph nodes (up to 3 nodes) exceeds
  • 1 cm per day OR the diameter of the largest lymph node exceeds 5 cm during the 5 day wash out. 2. For subjects with lymphocytosis, the increase in the ALC exceeds 2x109/L per day OR the ALC exceeds 100,000 x109/L during the 5-day wash out; b. Arm C: No minimum washout is required after discontinuation of ibrutinib (or other BTK inhibitors) c. Approved PI3 kinase inhibitors: Subjects may start study treatment within 3 days of discontinuation of approved PI3 kinase inhibitors.
  • 14. Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management 15. Active disease transformation (ie, Richter's Syndrome); subjects with Richter's Syndrome that has resolved > 2 years from signing the ICD are eligible.
  • 16. Known acute or chronic pancreatitis 17. Pregnant or lactating females
  • Arm B only (CC-122 in combination with ibrutinib):
  • 18. Prior treatment with a BTK inhibitor 19. Presence of transfusion-dependent thrombocytopenia or a history of bleeding disorders or clinical conditions (eg, gastrointestinal bleeding or constitutional disorders) that may increase risk of life-threatening bleeding when thrombocytopenic 20. History of stroke or intracranial hemorrhage within 6 months prior to signing the ICD 21. Medications that are strong inhibitors or inducers of CYP3A4/5 (eg, itraconazole, ketoconazole, clarithromycin, ritonavir, phenytoin, pentobarbital, and rifampin) should be changed; subjects who cannot change these medications must be excluded.
  • 22. Use of concomitant anticoagulation with warfarin or other vitamin K antagonists is prohibited, as is treatment with these agents in the 7 days prior to signing the ICD. The use of other anticoagulants (eg, heparins) and anti-platelet agents is allowed per investigator's discretion.
  • Arm C only (CC-122 in combination with obinutuzumab):
  • 23. Hypersensitivity to obinutuzumab

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

United States8 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Ohio State University Medical CenterJames Cancer Hospital

    Columbus, Ohio, 43210

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center The University of Texas

    Houston, Texas, 77030

  • University of California San Diego

    La Jolla, California, 92093

  • The West Clinic

    Memphis, Tennessee, 38120

  • Weill Cornell Medical College Dr. Feldman's Office

    New York, New York, 10065

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98118

Other trials in United States

Spain5 sites

  • Hospital Universitario Vall D hebron

    Barcelona, 08035

  • Fundacion Jimenez Daaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Germany4 sites

  • Universitat zu Koln

    Cologne, 50937

  • Universitaetsklinikum EssenInnere Klinik und Poliklinik

    Essen, 45147

  • University of Schleswig-Holstein

    Kiel, 24116

  • Universitatsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Italy4 sites

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

  • Ospedale Niguarda Milano

    Milan, 20162

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

Other trials in Italy

Austria3 sites

  • University Hospital Innsbruck

    Innsbruck, 6020

  • University Hospital of Salzburg St Johanns Spital

    Salzburg, 5020

  • Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

About this study

Official title: Phase 1/2 Study to Determine the Safety, Pharmacokinetics, and Efficacy of Single Agent CC-122 and the Combinations CC-122 AND Ibrutinib and CC-122 and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with ibrutinib and obinuzutumab.

CC-122 has multiple activities, including immune modulation of several immune cell subsets and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience.

Read the detailed description

The primary objectives of this Phase 1/2 Study are to determine the safety of single agent CC-122 and the safety, tolerability, and RP2D of CC-122 when administered in combination with ibrutinib and in combination with obinutuzumab to subjects with CLL/SLL. The secondary objectives are to evaluate the PK profiles of subjects administered CC-122 in combination with ibrutinib and in combination with obinutuzumab, to determine ibrutinib concentrations when given alone and in combination with CC-122 and to evaluate the preliminary efficacy of CC-122 at selected dose levels/regimens.

Being tested
CC-122, Ibrutinib, Obinutuzumab
Keywords
CC-122, Pharmacokinetics, Safety, Ibrutinib, Obinutuzumab, GA101, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • CC-122Drug

    CC-122 will be administered daily starting at Cycle 1 Day 1 in 28-day cycles until disease progression, unacceptable toxicity, or discontinuation for any other reason.

  • IbrutinibDrug

  • ObinutuzumabDrug

    Obinutuzumab will be administered as an intravenous (IV) infusion at a dose of 100 mg on Cycle 1 Day 1 and 900 mg on Cycle 1 Day 2 and 1000 mg on Cycle 1 Days 8 and 15. The dose of obinutuzumab on Days 1 and 2 of Cycle 1 may be adjusted per institutional practice as long as the combined dose equals 1000 mg. Obinutuzumab will be administered at a dose of 1000 mg on Day 1 of Cycles 2 through 6.

Study groups in NCT02406742
Study groupRoleWhat they receive
CC-122 Single AgentExperimentalAn intrasubject dose escalation design was selected to determine the safety of single agent CC-122 (Arm A) in order to reach an optimal, clinically active dose and to mitigate the risk of early tumor flare reactions, based on earlier experience with lenalidomide monotherapy in CLL.
Receives: Drug: CC-122
CC-122 in combination with ibrutinibExperimentalAscending fixed dose cohorts evaluated in a 3 + 3 dose-finding design will be used to determine the safety and tolerability of the combination of CC-122 and ibrutinib to determine the NTD, MTD, and Recommended Phase 2 Dose (RP2D). An intrasubject dose escalation cohort may also be evaluated at the discretion of the Safety Review Committee. The RP2D of the combination may be evaluated in ibrutinib-naïve and high-risk CLL patients in the dose expansion phase to continue to evalute safety and efficacy.
Receives: Drug: CC-122; Drug: Ibrutinib
CC-122 in combination with obinutuzumabExperimentalAscending fixed dose cohorts evaluated in a 3 + 3 dose-finding design will be used to determine the safety and tolerability of the combination of CC-122 and obinutuzumab to determine the , MTD, and Recommended Phase 2 Dose (RP2D). An intrasubject dose escalation cohort may also be evaluated at the discretion of the Safety Review Committee.. The RP2D of the combination may be evaluated in CLL patients who failed a B-cell receptor pathway inhibitor or venetoclax in the dose expansion phase to continue to evalute safety and efficacy.
Receives: Drug: CC-122; Drug: Obinutuzumab

What is being measured

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

  1. Number of Participants and Severity of AEs

    Number and severity of adverse events using the NCI CTCAE criteria (version 4.03), including DLTs

    Measured: Approximately 60 Months

  2. Determination of Non Tolerated Dose (NTD) and Maximum Tolerated Dose (MTD)

    Determination of the NTD and MTD in CC-122 in combination with ibrutinib and CC-122 in combination with obinutuzumab

    Measured: 52 weeks

Secondary outcomes (9)

  1. CC-122 Plasma Concentrations When Administered Alone or in Combination With Ibrutinib or Obinutuzumab

    CC-122 plasma concentrations when administered alone or in combination with ibrutinib or obinutuzumab

    Measured: Approximately 60 Months

  2. Ibrutinib Plasma Concentrations When Administered in Combination With CC-122

    Geometric mean concentration of Ibrutinib when administered alone or in combination with CC-122

    Measured: Approximately 60 Months

  3. Best Overall Response (BOR)

    Best overall response [CR, CRi, nPR, PR, PRL (applicable to Arm B only)] CR = Complete Response CRi = Complete response with incomplete marrow recovery nPR = nodular Partial Response PR = Partial response PRL= Partial response with lymphocytosis

    Measured: Approximately 60 Months

  4. Minimal Residual Disease Response Rate

    Minimal Residual Disease Response Rate in bone marrow and peripheral blood

    Measured: Approximately 60 Months

  5. Duration of Response

    measured from the time the response is first met until the first date that progressive disease or death is documented. Participants who neither progress nor die or who withdrew consent or are lost to follow-up prior to documentation of progression will be censored at the date of their last adequate response assessment.

    Measured: Approximately 60 Months

  6. Progression Free Survival (PFS)

    will be calculated as the time from irst IP (i.e. any study drug) dose date to the first documented progression or death due to any cause during or after the treatment period, whichever occurs first.

    Measured: Approximately 60 Months

  7. Cmax When Administered Alone or in Combination With Ibrutinib

    Peak (maximum) drug plasma concentration

    Measured: Approximately 60 Months

  8. Tmax of CC-122 When Administered Alone or in Combination With Ibrutinib

    Time to peak (maximum) drug concentration

    Measured: Approximately 60 Months

  9. AUC of CC-122 When Administered Alone or in Combination With Ibrutinib

    Area under the concentration -time curve calculated to the last observable concentration at time t

    Measured: Approximately 60 Months

Timeline

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

  1. First posted2 Apr 2015 (estimated)
  2. Study start27 Jul 2015
  3. Primary completion7 Jul 2020
  4. Study completion7 Jul 2020

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406742
Sponsor's protocol ID
CC-122-CLL-001
Acronym
ENHANCE
Status last verified
Aug 2021
First submitted
30 Mar 2015
Last updated
20 Sep 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CC-122, Ibrutinib and Obinutuzumab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Celgene at 24 sites in 5 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 41 inclusion and 43 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Spain, Germany, Italy, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2021). 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?

Number of Participants and Severity of AEs (time frame: Approximately 60 Months). 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 NCT02406742.

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 20 Sep 2021.

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