Leukemia, Myeloid, AcutePhase 1/2NCT00906945
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia
A Phase 1/2 study testing G-CSF, Plerixafor and Mitoxantrone in people with Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- G-CSF, Plerixafor and Mitoxantrone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2011to Sep 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myeloid leukemia diagnosed by WHO criteria with one of the following:
- Primary refractory disease following no more than 2 cycles of induction chemotherapy
- First relapse with no prior unsuccessful salvage chemotherapy
- Age between 18 and 70 years old
- ECOG performance status ≤ 3
- Adequate organ function defined as:
Show all 13Show fewer
- Calculated creatinine clearance ≥ 50 ml/min
- AST, ALT, total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
- Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
- Are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
- Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
- Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
- Able to provide signed informed consent prior to registration on study
Who cannot join
- Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
- Peripheral blood blast count ≥ 20 x 103 /mm3
- Active CNS involvement with leukemia
- Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
- Pregnant or nursing
- Received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks
- Received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
- Severe concurrent illness that would limit compliance with study requirements
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center
Houston, Texas, 77030
Washington University
St Louis, Missouri, 63110
About this study
Official title: Chemosensitization With Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia
This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.
Read the detailed description
In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through the following:
- Addition of G-CSF, which down regulates SDF-1 expression and acts synergistically with plerixafor in stem cell mobilization
- Intravenous instead of subcutaneous dosing of plerixafor to improve kinetics of administration.
- Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4 blockade.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- G-CSF, Plerixafor, Mitoxantrone, Etoposide, Cytarabine
- Keywords
- stem cell mobilization, chemosensitization, CXCR4, SDF-1, CXCL-12
- 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.
G-CSFDrug
Also called filgrastim, Neupogen
PlerixaforDrug
Also called AMD3100, Mozobil
MitoxantroneDrug
Also called Novantrone
EtoposideDrug
Also called VP-16, Vepesid, Etopophos
CytarabineDrug
Also called Ara-C, Cytosar
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | * G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 240 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 Receives: Drug: G-CSF; Drug: Plerixafor; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
| Dose Level 2 | Experimental | * G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 320 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 Receives: Drug: G-CSF; Drug: Plerixafor; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
| Dose Level 3 | Experimental | * G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 420 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 Receives: Drug: G-CSF; Drug: Plerixafor; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
| Dose Level 4 | Experimental | * G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 560 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 Receives: Drug: G-CSF; Drug: Plerixafor; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
| Dose Level 5 | Experimental | * G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 750 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 Receives: Drug: G-CSF; Drug: Plerixafor; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
| MTD - Phase II | Experimental | * G-CSF MTD determined in Phase 1 SQ on Days 1-8
* Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 Receives: Drug: G-CSF; Drug: Plerixafor; Drug: Mitoxantrone; Drug: Etoposide; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC
Measured: Completion of Phase I enrollment (17 months)
Phase II: Complete Response Rate (CR+CRi)
- Morphologic complete remission (CR): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1,000/mm3, platelet count > 100,000/mm3.
- Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1,000/mm3 or thrombocytopenia <100,000/mm3.
Measured: 45 days
Secondary outcomes (12)
Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency
Measured: 30 days following end of treatment
Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery
-Neutrophil recovery is defined as absolute neutrophil count (ANC) >= 500/mm^3
Measured: Up to 62 days after treatment
Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery
-Neutrophil recovery is defined as absolute neutrophil count >= 1000/mm^3
Measured: Up to 62 days after treatment
Time to Hematologic Recovery as Measured by Time to Platelet Recovery
-Platelet recovery is defined as platelets >= 50,000/mm^3
Measured: Up to 62 days after treatment
Time to Hematologic Recovery as Measured by Time to Platelet Recovery
-Platelet recovery is defined as platelets >= 100,000/mm3
Measured: Up to 62 days after treatment
Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells
Measured: 6 hours after plerixafor
Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count
Measured: 6 hours after plerixafor
Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity
Measured: 6 hours after plerixafor
Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity
Measured: 6 hours after plerixafor
Time to Progression
Recurrence / morphologic relapse: Defined as reappearance of blasts in the blood or the finding of > 5% blasts in the BM, not attributable to any other cause. New dysplastic changes are considered a relapse. If there are no blasts in the peripheral blood and 5-19% blasts in the BM, the BM biopsy and aspirate should be repeated in > 1 week to confirm relapse.
Measured: 2 years
Time to Treatment Failure
Measured: 8 days
Overall Survival
Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.
Measured: Median follow-up was 34.6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startFeb 2011
- Primary completionNov 2012
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey L. Uy, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906945
- Sponsor's protocol ID
- 10-0910 / 201106039
- Status last verified
- Feb 2017
- First submitted
- 13 May 2009
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemosensitization With Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00906945
- Acronym / sponsor ID
- 10-0910 / 201106039
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- stem cell mobilization, chemosensitization, CXCR4, SDF-1, CXCL-12
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.
Detailed description
In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through the following:
- Addition of G-CSF, which down regulates SDF-1 expression and acts synergistically with plerixafor in stem cell mobilization
- Intravenous instead of subcutaneous dosing of plerixafor to improve kinetics of administration.
- Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4 blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: G-CSF, Drug: Plerixafor, Drug: Mitoxantrone, Drug: Etoposide, Drug: Cytarabine* G-CSF 10 mcg/kg SQ on Days 1-8 * Plerixafor 240 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 |
| Dose Level 2 | Experimental | Drug: G-CSF, Drug: Plerixafor, Drug: Mitoxantrone, Drug: Etoposide, Drug: Cytarabine* G-CSF 10 mcg/kg SQ on Days 1-8 * Plerixafor 320 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 |
| Dose Level 3 | Experimental | Drug: G-CSF, Drug: Plerixafor, Drug: Mitoxantrone, Drug: Etoposide, Drug: Cytarabine* G-CSF 10 mcg/kg SQ on Days 1-8 * Plerixafor 420 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 |
| Dose Level 4 | Experimental | Drug: G-CSF, Drug: Plerixafor, Drug: Mitoxantrone, Drug: Etoposide, Drug: Cytarabine* G-CSF 10 mcg/kg SQ on Days 1-8 * Plerixafor 560 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 |
| Dose Level 5 | Experimental | Drug: G-CSF, Drug: Plerixafor, Drug: Mitoxantrone, Drug: Etoposide, Drug: Cytarabine* G-CSF 10 mcg/kg SQ on Days 1-8 * Plerixafor 750 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 |
| MTD - Phase II | Experimental | Drug: G-CSF, Drug: Plerixafor, Drug: Mitoxantrone, Drug: Etoposide, Drug: Cytarabine* G-CSF MTD determined in Phase 1 SQ on Days 1-8 * Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Acute myeloid leukemia diagnosed by WHO criteria with one of the following:
- Age between 18 and 70 years old
- ECOG performance status ≤ 3
- Adequate organ function defined as:
- Are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
Key exclusion criteria (8 listed)
- Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
- Peripheral blood blast count ≥ 20 x 103 /mm3
- Active CNS involvement with leukemia
- Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFAlso: filgrastim, Neupogen | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, MTD - Phase II |
| PlerixaforAlso: AMD3100, Mozobil | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, MTD - Phase II |
| MitoxantroneAlso: Novantrone | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, MTD - Phase II |
| EtoposideAlso: VP-16, Vepesid, Etopophos | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, MTD - Phase II |
| CytarabineAlso: Ara-C, Cytosar | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, MTD - Phase II |
Primary outcome
Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC
Time frame: Completion of Phase I enrollment (17 months)
Phase II: Complete Response Rate (CR+CRi)
Time frame: 45 days
* Morphologic complete remission (CR): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1,000/mm3, platelet count > 100,000/mm3. * Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1,000/mm3 or thrombocytopenia <100,000/mm3.
12 secondary outcomes
Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency
Time frame: 30 days following end of treatment
Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery
Time frame: Up to 62 days after treatment
Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery
Time frame: Up to 62 days after treatment
Time to Hematologic Recovery as Measured by Time to Platelet Recovery
Time frame: Up to 62 days after treatment
Time to Hematologic Recovery as Measured by Time to Platelet Recovery
Time frame: Up to 62 days after treatment
Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells
Time frame: 6 hours after plerixafor
Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count
Time frame: 6 hours after plerixafor
Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity
Time frame: 6 hours after plerixafor
Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity
Time frame: 6 hours after plerixafor
Time to Progression
Time frame: 2 years
Time to Treatment Failure
Time frame: 8 days
Overall Survival
Time frame: Median follow-up was 34.6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey L. Uy, M.D. principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing G-CSF, Plerixafor and Mitoxantrone in people with Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 3 sites in United States.
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 8 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 4 Apr 2017). 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?
Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC (time frame: Completion of Phase I enrollment (17 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?
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 4 Apr 2017.