Myelodysplastic SyndromePhase 1NCT00402558
Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
A Phase 1 study testing Thymoglobulin, Busulfan and Fludarabine in people with Myelodysplastic Syndrome and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated dose of NK cells. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Myelodysplastic Syndrome, Leukemia
- What is being tested?
- Thymoglobulin, Busulfan and Fludarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 2014
- Phase
- Phase 1
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with age </= 70 years with one of of the following: Acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; Myelodysplastic syndromes with intermediate or high risk IPSS score; CML which has progressed to accelerated phase or blast crisis despite imatinib treatment
- Patients must have an HLA matched (HLA A, B, C, DR) related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation. (Recent large analyses of the National Marrow Donor Program indicate that a mis-match at the DQ locus has no adverse effect on outcome. The current national standard of care is to consider only these 4 loci in identifying suitably "matched" donors.)
- Patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C and Bw antigens.
- Zubrod performance status </= 2.
- Left ventricular ejection fraction >/= 45%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
- No symptomatic pulmonary disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% of expected, corrected for hemoglobin.
Show all 11Show fewer
- Serum creatinine </= 1.8mg%.
- Serum glutamate pyruvate transaminase (SGPT) </= 200 IU/ml unless related to patients malignancy.
- Bilirubin </= 1.5 mg/dl (unless Gilbert's syndrome).No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
- No known allergy to mouse proteins or monoclonal antibodies
Who cannot join
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Pleural/pericardial effusion or ascites estimated to be >1L.
- HIV-positive.
- Pregnancy: Positive Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known allergy to mouse proteins.
- Patient has received other systemic chemotherapeutic drugs (including Mylotarg) within 14 days prior to trial enrollment or has unresolved grade >1 toxicity from prior chemotherapy treatment. (Hydroxyurea or low dose ara-c less than or equal to 20 mg/m2/d is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed lumbar microdiscectomy (LMD), that is in remission prior to enrollment on this study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alloreactive NK Cells With Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplantation for AML and MDS
The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours who has certain genetic type in their blood called HLA, that almost matches yours. The stem cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or unrelated donor. The safety of this treatment will also be studied.
Read the detailed description
NK cells are part of the immune system (the cells in your body that fight disease). Sometimes, NK cells react against and fight leukemia cells that are mismatched with your body for certain HLA tissue type proteins. When the NK cells react, these cells are called "alloreactive NK cells."
In this study, researchers will collect alloreactive NK cells from the blood of a relative of yours whose HLA proteins do not match yours exactly. The NK cells are separated from the blood using a machine called a CLINIMACs system. This machine uses special kinds of cells and magnetic beads to separate the NK cells. The drug interleukin-2 is then added to the NK cells, to improve their function. The interleukin-2 will be washed out of the cell sample before it is given to you. The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.
If you are able to take part in this study, you will receive high-dose chemotherapy for 4 days. You will receive fludarabine over about 30 minutes daily as an intravenous (IV--through a needle in your vein) infusion . You will also receive busulfan over 3 hours by IV once a day. About 2 days later, you will be given the infusion of the alloreactive NK cells by IV. Patients will receive one of 3 dose levels. Some patients will receive interleukin-2 daily for 4 days to enhance the function of the NK cells.
Five (5) days after the NK cell infusion, thymoglobulin will be given to you by IV daily for 3 days. Thymoglobulin is an immunosuppressive treatment to reduce the risk of graft rejection. Then blood stem cells will be administered IV from a different stem cell donor whose HLA type matches yours.
You will receive the drugs tacrolimus and methotrexate to help lower the risk of a reaction called "graft-vs.-host disease" (GVHD). GVHD is when the donated immune cells in the transplant react against the body of the person receiving the cells. Tacrolimus will be given by IV for about 2 weeks, and after that it is given by mouth as a pill for at least 3 months. Methotrexate will be given as an IV injection for 3 to 4 doses over the first 11 days after the stem cell transplant.
You will also receive the drug G-CSF (Neupogen) as an injection under the skin until your blood cell counts reach a certain high enough level.
You will need to stay in the hospital for about 4 weeks. After you leave the hospital, you will continue as an outpatient in the hospital area, which means you will have to stay close enough to be able to come back for any visits for at least 100 days after the transplant.
You will be asked to come back to the clinic at 3, 6, and 12 months after your transplant for routine safety testing. This will include a physical exam, a bone marrow biopsy, and routine blood draws.
This is an investigational study. The way the researchers make the alloreactive NK cells using the CLINIMACs device is investigational. The CliniMACS device is not FDA approved. At this time, it is being used in research only. Up to 18 patients will take part in this study.
- Conditions
- Myelodysplastic Syndrome, Leukemia
- Being tested
- Thymoglobulin, Busulfan, Fludarabine, Alloreactive NK Infusion, G-CSF
- Keywords
- Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia, NK Cells, Natural Killer Cells, Fludarabine, Busulfan, Thymoglobulin, AML, CML, MDS, ATG, Antithymocyte globulin, Busulfex, Myleran®, Fludarabine Phosphate, G-CSF, Filgrastim, Neupogen
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
Also called ATG, Antithymocyte globulin
1.5 mg/kg By Vein Daily x 3 Days
BusulfanDrug
Also called Busulfex, Myleran®
130 mg/m^2 By Vein Over 3 Hours x 4 Days
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
40 mg/m^2 By Vein Over 30 Minutes x 4 Days
Alloreactive NK InfusionProcedure or surgery
Alloreactive NK infusion from haploidentical donor on Day -8. The alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7.
G-CSFDrug
Also called Filgrastim, Neupogen
5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 x 109/L for 3 consecutive days.
TacrolimusDrug
Also called Prograf
Starting dose of 0.015 mg/kg as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present.
MethotrexateDrug
5 mg/m2 intravenously on Days 1, 3 and 6 and Day +11 post transplant.
Interleukin-2Drug
Also called Aldesleukin, IL-2, Proleukin
0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4 only to participants receiving fourth dose level of NK cells.
| Study group | Role | What they receive |
|---|---|---|
| Thymoglobulin + Busulfan + Fludarabine | Experimental | Thymoglobulin 1.5 mg/kg by vein for 3 days. Busulfan 130 mg/m^2 by vein for 4 days. Fludarabine 40 mg/m^2 by vein for 4 days. Alloreactive NK infusion from haploidentical donor on Day -8. Alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7 NK Cells plus systemic interleukin-2 treatment. The 4th dose level is 3 x 107 NK cells/kg plus systemic interleukin-2 at a dose of 0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4.
G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count is > 500 x 109/L for 3 consecutive days. Tacrolimus starting dose of 0.015 mg/kg daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present. Methotrexate 5 mg/m2 by vein on Days 1, 3 and 6 and Day +11 post transplant. Receives: Drug: Thymoglobulin; Drug: Busulfan; Drug: Fludarabine; Procedure: Alloreactive NK Infusion; Drug: G-CSF; Drug: Tacrolimus; Drug: Methotrexate; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of NK cells
Measured: Continual Reassessment (Baseline, 3, 6 and 12 Months Follow Ups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard E. Champlin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402558
- Sponsor's protocol ID
- 2005-0508
- Other IDs
- NCI-2012-01484, 1P01CA100265
- Status last verified
- May 2015
- First submitted
- 20 Nov 2006
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alloreactive NK Cells With Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplantation for AML and MDS
- ClinicalTrials.gov ID
- NCT00402558
- Acronym / sponsor ID
- 2005-0508
- Conditions
- Myelodysplastic Syndrome, Leukemia
- Keywords
- Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia, NK Cells, Natural Killer Cells, Fludarabine, Busulfan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours who has certain genetic type in their blood called HLA, that almost matches yours. The stem cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or unrelated donor. The safety of this treatment will also be studied.
Detailed description
NK cells are part of the immune system (the cells in your body that fight disease). Sometimes, NK cells react against and fight leukemia cells that are mismatched with your body for certain HLA tissue type proteins. When the NK cells react, these cells are called "alloreactive NK cells."
In this study, researchers will collect alloreactive NK cells from the blood of a relative of yours whose HLA proteins do not match yours exactly. The NK cells are separated from the blood using a machine called a CLINIMACs system. This machine uses special kinds of cells and magnetic beads to separate the NK cells. The drug interleukin-2 is then added to the NK cells, to improve their function. The interleukin-2 will be washed out of the cell sample before it is given to you. The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.
If you are able to take part in this study, you will receive high-dose chemotherapy for 4 days. You will receive fludarabine over about 30 minutes daily as an intravenous (IV--through a needle in your vein) infusion . You will also receive busulfan over 3 hours by IV once a day. About 2 days later, you will be given the infusion of the alloreactive NK cells by IV. Patients will receive one of 3 dose levels. Some patients will receive interleukin-2 daily for 4 days to enhance the function of the NK cells.
Five (5) days after the NK cell infusion, thymoglobulin will be given to you by IV daily for 3 days. Thymoglobulin is an immunosuppressive treatment to reduce the risk of graft rejection. Then blood stem cells will be administered IV from a different stem cell donor whose HLA type matches yours.
You will receive the drugs tacrolimus and methotrexate to help lower the risk of a reaction called "graft-vs.-host disease" (GVHD). GVHD is when the donated immune cells in the transplant react against the body of the person receiving the cells. Tacrolimus will be given by IV for about 2 weeks, and after that it is given by mouth as a pill for at least 3 months. Methotrexate will be given as an IV injection for 3 to 4 doses over the first 11 days after the stem cell transplant.
You will also receive the drug G-CSF (Neupogen) as an injection under the skin until your blood cell counts reach a certain high enough level.
You will need to stay in the hospital for about 4 weeks. After you leave the hospital, you will continue as an outpatient in the hospital area, which means you will have to stay close enough to be able to come back for any visits for at least 100 days after the transplant.
You will be asked to come back to the clinic at 3, 6, and 12 months after your transplant for routine safety testing. This will include a physical exam, a bone marrow biopsy, and routine blood draws.
This is an investigational study. The way the researchers make the alloreactive NK cells using the CLINIMACs device is investigational. The CliniMACS device is not FDA approved. At this time, it is being used in research only. Up to 18 patients will take part in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thymoglobulin + Busulfan + Fludarabine | Experimental | Drug: Thymoglobulin, Drug: Busulfan, Drug: Fludarabine, Procedure: Alloreactive NK Infusion, Drug: G-CSF, Drug: Tacrolimus, Drug: Methotrexate, Drug: Interleukin-2Thymoglobulin 1.5 mg/kg by vein for 3 days. Busulfan 130 mg/m^2 by vein for 4 days. Fludarabine 40 mg/m^2 by vein for 4 days. Alloreactive NK infusion from haploidentical donor on Day -8. Alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7 NK Cells plus systemic interleukin-2 treatment. The 4th dose level is 3 x 107 NK cells/kg plus systemic interleukin-2 at a dose of 0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count is > 500 x 109/L for 3 consecutive days. Tacrolimus starting dose of 0.015 mg/kg daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present. Methotrexate 5 mg/m2 by vein on Days 1, 3 and 6 and Day +11 post transplant. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with age </= 70 years with one of of the following: Acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; Myelodysplastic syndromes with intermediate or high risk IPSS score; CML which has progressed to accelerated phase or blast crisis despite imatinib treatment
- Patients must have an HLA matched (HLA A, B, C, DR) related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation. (Recent large analyses of the National Marrow Donor Program indicate that a mis-match at the DQ locus has no adverse effect on outcome. The current national standard of care is to consider only these 4 loci in identifying suitably "matched" donors.)
- Patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C and Bw antigens.
- Zubrod performance status </= 2.
- Left ventricular ejection fraction >/= 45%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
Key exclusion criteria (6 listed)
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Pleural/pericardial effusion or ascites estimated to be >1L.
- HIV-positive.
- Pregnancy: Positive Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known allergy to mouse proteins.
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 |
|---|---|---|
| ThymoglobulinAlso: ATG, Antithymocyte globulin1.5 mg/kg By Vein Daily x 3 Days | Drug | Thymoglobulin + Busulfan + Fludarabine |
| BusulfanAlso: Busulfex, Myleran®130 mg/m^2 By Vein Over 3 Hours x 4 Days | Drug | Thymoglobulin + Busulfan + Fludarabine |
| FludarabineAlso: Fludarabine Phosphate, Fludara40 mg/m^2 By Vein Over 30 Minutes x 4 Days | Drug | Thymoglobulin + Busulfan + Fludarabine |
| Alloreactive NK InfusionAlloreactive NK infusion from haploidentical donor on Day -8. The alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7. | Procedure or surgery | Thymoglobulin + Busulfan + Fludarabine |
| G-CSFAlso: Filgrastim, Neupogen5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 x 109/L for 3 consecutive days. | Drug | Thymoglobulin + Busulfan + Fludarabine |
| TacrolimusAlso: PrografStarting dose of 0.015 mg/kg as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present. | Drug | Thymoglobulin + Busulfan + Fludarabine |
| Methotrexate5 mg/m2 intravenously on Days 1, 3 and 6 and Day +11 post transplant. | Drug | Thymoglobulin + Busulfan + Fludarabine |
| Interleukin-2Also: Aldesleukin, IL-2, Proleukin0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4 only to participants receiving fourth dose level of NK cells. | Drug | Thymoglobulin + Busulfan + Fludarabine |
Primary outcome
Maximum Tolerated Dose of NK cells
Time frame: Continual Reassessment (Baseline, 3, 6 and 12 Months Follow Ups)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Richard E. Champlin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thymoglobulin, Busulfan and Fludarabine in people with Myelodysplastic Syndrome and Leukemia, run by M.D. Anderson Cancer Center at 1 site 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 11 inclusion and 6 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 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
Maximum Tolerated Dose of NK cells (time frame: Continual Reassessment (Baseline, 3, 6 and 12 Months Follow Ups)). 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 8 May 2015.