Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT

January 3, 2025 updated by: Gruppo Italiano Trapianto di Midollo Osseo

Phase II Study on Venetoclax (VEN) Plus Decitabine (DEC) (VEN-DEC) for Elderly (≥60 <75years) Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Elegible for Allogeneic Stem Cell Transplantation (allo-SCT)

This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the safety and efficacy of the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) as "bridge" to allo-SCT in elderly (≥ 60 - < 75 years) AML patients. The primary objective is to evaluate the proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML, eligible for allo-SCT, treated with the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/Cri/MLFS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML, eligible for allo-SCT, treated with the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/CRi/MLFS, organized under the auspices of the Gruppo Italiano TRapianti di Midollo Osseo (GITMO) that involves the prinicipla centres active in transplantation of any kind of stem cells in Italy. The target for this study is 100 patients.

Biologic characterization of AML will be performed at each participating Center by flow cytometry, cytogenetics and RT-qPCR on target genes (FLT3, NPM1A, WT1,) at disease onset. MRD monitoring will be performed at each participating Center by flow cytometry, cytogenetics and RT-qPCR (routine assessment) at the time of CR/CRi/MLFS before allo-SCT and during follow up (at least 4 timepoints: +100 days, +180 days, +1 year and +2 years from allo-SCT).

Genomic analysis by NGS gene-panel (Sophia Genetics) exploring the mutational status of the genes involved in of AML will be centralized in Brescia Laboratory at the enrollment into the study (diagnosis) and at the time of no response (PR/NR), before allo-SCT in patients in CR/CRi/MLFS and in case of relapse, at any time.

Primary Objectives To evaluate the proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML eligible for allo-SCT treated with the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/CRi/MLFS.

Secondary Objectives

  • Incidence and severity of adverse drug reactions (ADR) classified by System Organ Class (SOC) and preferred term (PT) from start treatment with Ventoclax and Decitabine to allo-SCT
  • Efficacy of VEN-DEC combination
  • Evaluation of the outcome of allo-SCT in term of:1) Incidence of graft failure at day +30, +100 from allo-SCT2) Incidence of Non-Relapse Mortality (NRM) at day +100, 1 year and 2 years from allo-SCT3) Incidence and severity of acute GVHD at day +100 from allo-SCT4) Incidence and severity of chronic GVHD at 1 year and 2 years from allo-SCT5) Probability of GRFS (GVHD free, relapse free survival) at 1 and 2 years from allo-SCT
  • Relapse incidence (RI) at 1 year and 2 years from allo-SCT
  • Disease-free survival (DFS) at 1 and 2 years from allo-SCT
  • Overall Survival (OS) at 1 and 2 years from allo-SCT
  • Correlation of immunophenothype, cytogenetic, molecular and NGS-genomic profiles with sensitivity (CR - CRi - MLFS) or resistance (PR/NR) to "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC)
  • Correlation of immunophenothype, cytogenetic, molecular and NGS-genomic profiles with the outcome of allo-SCT in terms of NRM, probability of RI, DFS, OS.

This study has 2 endpoints

Primary Endpoint Proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML eligible for allo-SCT treated with the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/CRi/MLFS.

Secondary Endpoints

  • Efficacy of VEN-DEC combination
  • Cumulative incidence of graft failure at +30 days, +100 days from transplant
  • Outcome of allo-SCT in term of NRM at day +100, 1 year and 2 years from allo-SCT
  • Cumulative incidence and severity of acute GvHD at 100 days after transplant
  • Cumulative incidence and severity of chronic GvHD at 1 and 2 years post transplant
  • RI at 1 and 2 year after transplantation from days of transplant.
  • OS at 1 and 2 years post transplant
  • DFS at 1 and 2 years post transplant
  • 1 and 2 year probability of GRFS
  • Correlation of immunophenothype, cytogenetic, molecular and NGS-genomic profiles with sensitivity (CR - CRi - MLFS) or resistance (PR-NR) to "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC)
  • Correlation of immunophenothype, cytogenetic, molecular and NGS-genomic profiles with the outcomes of allo-SCT: NRM, RI, DFS, OS.

Biologic characterization of AML will be performed at each participating Center by flow cytometry, cytogenetics and RT-qPCR on target genes (FLT3, NPM1A, WT1,…) at disease onset. MRD monitoring will be performed at each participating Center by flow cytometry, cytogenetics and RT-qPCR (routine assessment) at the time of CR/CRi/MLFS, before allo-SCT and during follow up (at least 4 timepoints: +100 days, +180 days, +1 year and +2 years from allo-SCT).Genomic analysis by NGS gene-panel (Sophia Genetics) exploring the mutational status of the genes involved in of AML will be centralized in Brescia Laboratory at the enrollment into the study (diagnosis) and at the time of no response (PR/NR), before allo-SCT in patients in CR/CRi/MLFS and in case of relapse, at any time.

Venetoclax will be given with a 3-day ramp up beginning with 100 mg dose on Day 1 to reach the final dose of 400 mg on Day 3 of Cycle 1. Venetoclax will be continued at 400 mg daily. Tumor lysis prophylaxis will be administered from day -4, cycle 1 (oral uric acid reducing agent and hydration with at least 1.5 L/day).

Decitabine will be administered at the dose of 20 mg/sqm intravenously from day 1 to day 5 every 28 days (VEN-DEC) for 2 cycles. The response will be assessed after the 2nd Cycle VEN-DEC according to ELN criteria. In case of CR/CRi/MLFS, patients will undergo allo-SCT within 2 months. A maximum of two additional VEN-DEC cycles is permitted while waiting for allo-SCT. In case of NR or PR after the 2nd Cycle VEN-DEC, two additional cycles of VEN-DEC will be administered and patients achieving CR/CRi/MLFS will undergo allo-SCT as soon as possible (within 2 months). Patients with NR or PR will be treated according to single center policy, including also allo-SCT.

Patients achieving Morphologic Leukemia-free State (MLFS) will be considered responsive patients, since the percentage of BM blast cells is < 5%. These patients may undergo allo-SCT after 2 - 4 cycles of VEN-DEC.Granulocyte colony stimulating factor (G-CSF) will be allowed during VEN-DEC in case of febrile neutropenia. Whenever clinically indicated, G-CSF use has to be notified tin the CRF.

Population for analysis The population for analysis in this trial will be the Intent to Treat (ITT) population. All patients who have received at least one therapeutic dose of study medications will be included in the ITT analysis.

Sample size calculation The study is designed as a Simon optimal two-Stage Phase II clinical trial, including a planned futility check: after enrollment of the first 30 patients the Investigator will pause for the futility check is at that time point the target 4 patients will not yet be admitted to allo-SCT. Based on the current literature, less than 10% of elderly (>60 <75 years) AML patients can be submitted to allo-SCT, due to no-response to induction conventional chemotherapy (NR or PR) and /or to treatment toxicity. Therefore, to test the null hypothesis (conventional chemotherapy) that p ≤0.10 versus the alternative (VEN-DEC) that p ≥0.20, the expected sample size is 89 patients, with a probability of early termination of 0.647, when true proportion is 0.1. Alpha error is 0.0478 and beta value 0.1982. If there are 3 or fewer patients submitted to allo-SCT in the first 30 enrolled patients, the trial will be terminated for futility. Otherwise, considering an overall 12% of drop-out rate, 70 additional patients will be accrued for a total of 100 patients: in the second stage 70 patients will only be enrolled if at least 4 patients of the first stage undergo allo-SCT. The null hypothesis will be rejected if 14 of more patients treated with VEN-DEC will be submitted to allo-SCT in CR/CRi/MLFS.

The study is considered completed when the 100th patient will be enrolled. It is planned to complete the total enrollment (100 patients) in 18 months, starting from the first patient enrolled.

The follow-up according to the protocol is 2 years for each patient from the day of enrollment. In the transplanted patients the pre-transplant period will be followed by 2 years post-transplant follow-up

The study will be performed in 4 years from the first patient enrolled according to the following times:

18 moths for enrollment (from the first patient) and for database completion and cleaning 24 months of follow up. In the transplanted patients the pre-transplant period will be followed by 2 years post-transplant follow-up 6 months for statistical analysis, drafting of the final report and paper.

The study will be conducted in accordance with the ethical principles derived from the Declaration of Helsinki, the CGP and regulations.

Before starting the study, the protocol will be sent to the Ethics Committee, in accordance with the current legislation on interventional study.

The protocol has been written and the study will be conducted according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonized tripartite Guideline for GCP, issued by European Union. IRB approval must be obtained prior to the starting of the trial. ICF must be submitted to appropriate authority or IRB together with clinical protocol for written approval.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Clinica di Ematologia. AOU Ospedali Riuniti di Ancona
      • Ascoli Piceno, Italy
        • UOC di Ematologia, Ospedale C e G Mazzoni
      • Bari, Italy
        • U.O. Ematologia con Trapianto, Policlinico di Bari
      • Bologna, Italy
        • Ospedale Seragnoli Malpighi
      • Brescia, Italy, 25100
        • USD, Trapianti di Midollo osseo, Azienda Spedali Civili di Brescia
      • Catania, Italy
        • Ospedale Policlinico di Catania, TMO
      • Cuneo, Italy
        • Struttura Complessa di Ematologia, Azienda Ospedaliera Santa Croce e Carle
      • Firenze, Italy
        • Terapie Cellulari e Medicina Trasfusionale, Ospedale Careggi
      • Genova, Italy
        • UO Ematologia, Programma Trapianti IRCCS Ospedale Policlinico San Martino, Genova
      • Milano, Italy
        • Div. di Ematologia e TMO, Istituto Nazionale Tumori
      • Milano, Italy
        • Unità Operativa di Ematologia e Trapianto Midollo Osseo (UTMO), Ospedale San Raffaele di Milano
      • Milano, Italy
        • Centro Trapianto Fondazione IRCCS Cà Granda - Osp. Maggiore
      • Milano, Italy
        • Div. di Ematologia, Talamona, Osp. Niguarda, Ca-Granda
      • Milano, Italy
        • Istituto Clinico Humanitas, Oncologia ed Ematologia
      • Monza, Italy, 20900
        • Ospedale San Gerardo
      • Napoli, Italy
        • UOSC Ematologia con Trapianto CSE, AORN A. Cardarelli, AORN Cardarelli
      • Palermo, Italy
        • CTMO Osp. V. Cervello Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
      • Pescara, Italy
        • Dip.di Ematologia, Osp. Civile di Pescara, Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico
      • Reggio Calabria, Italy
        • CTMO Centro Unico, Regionale Trapianti di Cellule Staminali e Terapie Cellulari, "A. Neri", Grande Osp. Bianchi, Melacrino Morelli
      • Roma, Italy
        • Policlinico Tor Vergata
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza
      • Venezia, Italy
        • UOC di Ematologia, Osp. dell'Angelo
      • Verona, Italy
        • Div. di Ematologia - Unità di TMO e Oncoematologia Pediatrica Policlinico GB Rossi
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71100
        • Unità Terapia Intensiva Ematologica e terapia cellulari - casa della sofferenza
    • Lecce
      • Tricase, Lecce, Italy
        • UO Ematologia e TMO - Ospedale C. Panico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Patients >60 <75 years of age

    • Diagnosis of AML eligible for allo-SCT from any donor
    • High- and Intermediate-Risk ELN
    • WBC <25x109/L (Hydroxyurea is permitted to meet this criterion)
    • adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)
    • adequate renal function (creatinine clearance ≥50 ml/min)
    • ECOG Performance Status < 2
    • Males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial.
    • Women of childbearing potential must use highly effective contraception for at least 1 month after the last dose of VEN and for however long the EU SmPC says for DEC
    • Willing and able to comply with all of the requirements and visits in the protocol.
    • Written and signed informed consent.

Exclusion Criteria:

  • • Previous treatment for AML (Hydroxyurea is allowed) or for an antecedent Myelodysplastic Syndrome (MDS).

    • Absence of informed consent
    • AML patients with t(15;17); t(8;21); inv(16)
    • Subject has known active CNS involvement with AML.
    • Low Risk ELN
    • grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment
    • Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min.
    • The evidence of HBV or HCV active infection (HBV DNA HCV RNA positive test).
    • Patients with HIV infection
    • Current uncontrolled infections
    • Patients with other life-threatening concurrent disease
    • Subjects with known hypersensitivity to any of the component medication
    • Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:
  • Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
  • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. • Participation in another clinical trial within 1 month before the start of this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment with VEN-DEC
Venetoclax will be given with a 3-day ramp up beginning with 100 mg dose on Day 1, with 200mg on Day 2, to reach the final dose of 400 mg on Day 3 of Cycle 1. Venetoclax will be continued at 400 mg daily. Tumor lysis prophylaxis will be administered from day -4, cycle 1 (oral uric acid reducing agent and hydration with at least 1.5 L/day).Decitabine will be administered at the dose of 20 mg/sqm intravenously from day 1 to day 5 every 28 days (VEN-DEC) for 2 cycles.
Combination product: Venetoclax and Decitabine
The prognosis of acute myeloid leukemia (AML) patients aged over 60 years is poor and allogeneic stem cell transplantation (allo-SCT) is the only curative option.The association VEN-DEC is a promising combination therapy for AML elderly patients who are fit and eligible for allo-SCT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Response to VEN-DEC chemo-free combination (ELN Guidelines)
Time Frame: At the end of cycle 2 (each cycle is 28 days)
response to VEN-DEC induction will be assessed on bone marrow according to the ELN Guidelines (13), as following: - CR without minimal residual disease (CR-MRD neg); (Complete Remission ) bone marrow blasts 5%) - CR remission with incomplete hematologic recovery (CRi): Morphologic Leukemia-free State (MLFS) Partial Remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; - Primary refractory disease/Non response (NR): No CR or CRi after 2 courses of VEN-DEC; excluding patients with death in aplasia or death due to indeterminate cause;
At the end of cycle 2 (each cycle is 28 days)
Allo-SCT
Time Frame: 18 months from 1st enrolled patient
Proportion of patients who undergo to allo-SCT in first CR/CRi/MLFS
18 months from 1st enrolled patient
Allo-SCT Engraftment
Time Frame: up to 24 weeks
Percentage of patients with Neutrophil engraftment and percentage of patients with platelet engraftment
up to 24 weeks
Overall Survival (OS)
Time Frame: at 2 year post transplant
at 2 year post transplant. OS is defined as the time from transplant to the date of death due to any cause or to the last date the patient was known to be alive (censored observation) or to the date of the data cut-off for final analysis
at 2 year post transplant
Cumulative incidence of Non-Relapse Mortality
Time Frame: at 100 days
NRM is defined as death due to any other cause than progression of malignancy after allogeneic stem cell transplantation. Cumulative incidence will be estimated at 100 days
at 100 days
Cumulative incidence of Non-Relapse Mortality
Time Frame: at 180 days
NRM is defined as death due to any other cause than progression of malignancy after allogeneic stem cell transplantation. Cumulative incidence will be estimated at 180 days
at 180 days
Cumulative incidence of Non-Relapse Mortality
Time Frame: at 365 days
NRM is defined as death due to any other cause than progression of malignancy after allogeneic stem cell transplantation. Cumulative incidence will be estimated at 365 days
at 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano Trapianto di Midollo Osseo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Domenico Russo, MD, Spedali Civili Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GITMO-VEN-DEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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