LeukemiaPhase 2NCT00782379
Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer
A Phase 2 study testing busulfan, cyclophosphamide and fludarabine phosphate in people with Leukemia and Lymphoma, run by Northside Hospital, Inc. at 1 site in United States.
Trial summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- What is being tested?
- busulfan, cyclophosphamide and fludarabine phosphate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 2012
- Phase
- Phase 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 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Diagnosis of one of the following high-risk hematologic malignancies:
- Chronic myelogenous leukemia meeting one of the following criteria:
- Disease in chronic phase and resistant to available tyrosine kinase inhibitors
- Disease in accelerated phase
- Disease with blast crisis that has entered into a second chronic phase after induction chemotherapy
- Acute myelogenous leukemia meeting the following criteria:
- Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
- Must meet one of the following criteria:
- Disease in second or subsequent complete remission
- Primary induction chemotherapy failure with disease subsequently entering complete remission
- Disease in first complete remission with poor-risk cytogenetics or arising from preceding hematological disease
- Myelodysplastic syndrome meeting at least one of the following criteria:
- Treatment-related
- Monosomy 7 or complex cytogenetics
- International prognostic scoring system score ≥ 1.5
- Chronic myelomonocytic leukemia
- Acute lymphocytic leukemia or lymphoblastic lymphoma meeting the following criteria:
- Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
- Must meet one of the following criteria:
- Disease in second or subsequent complete remission
- Acute lymphocytic leukemia with poor-risk karyotype [e.g., t(9;22) or bcr-abl fusion, t(4;11), or other MLL translocation] and in first complete remission
- Chronic lymphocytic leukemia or prolymphocytic leukemia meeting both of the following criteria:
- Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
- In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy)
- Hodgkin or non-Hodgkin lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse disease) meeting the following criteria:
- Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation
- In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- No available matched related or unrelated donor OR a matched related or unrelated donor will not be available in the time frame necessary to perform a transplant
- Availability of a first-degree relative (parent, child, sibling) matched at 3/6-5/6 loci (HLA-A, -B, -DR)
- Donor must be willing to donate mobilized peripheral blood stem cells
- No positive HLA crossmatch in the host-vs-graft direction or high titer donor-specific antibodies
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Bilirubin < 2 mg/dL (unless due to hemolysis, Gilbert syndrome, or primary malignancy)
- Creatinine < 2 mg/dL OR creatinine clearance ≥ 40 mL/min
- Not pregnant
- Fertile patients must use effective contraception
- LVEF (Left ventriculr ejection fraction) ≥ 45%
- FEV_1 and forced vital capacity ≥ 50% predicted
- No HIV positivity
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No immunosuppressive agents ≤ 24 hours after completion of post-transplant cyclophosphamide (including steroids as antiemetics)
Trial locations and contacts
1 site in 1 country.
United States1 site
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
About this study
Official title: A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.
Read the detailed description
OBJECTIVES:
Primary
- To estimate the incidence of graft rejection and severe graft-versus-host disease after myeloablative HLA-mismatched peripheral blood stem cell transplantation (PBSCT) from first-degree relatives in patients with high-risk hematologic malignancies.
Secondary
- To estimate overall survival, relapse, non-relapse mortality, and event-free survival in these patients.
- To characterize additional hematologic and non-hematologic toxicities of myeloablative haploidentical PBSCT.
- To characterize donor hematopoietic chimerism in peripheral blood stem cells after PBSCT.
OUTLINE:
- Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -2, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV over 1-2 hours on days -3 and -2.
- Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo infusion of unmanipulated peripheral blood stem cells on day 0.
- Post-transplant regimen: Patients receive high-dose cyclophosphamide IV over 1-2 hours on days 3 and 4, tacrolimus IV over 24 hours or orally twice daily on days 5-180, and oral mycophenolate mofetil 3 times daily on days 5-34 followed by a taper to day 90. Treatment continues in the absence of disease progression or clinically significant graft-vs-host disease.
After completion of PBSCT, patients are followed periodically for 1 year.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Being tested
- busulfan, cyclophosphamide, fludarabine phosphate, mycophenolate mofetil, tacrolimus
- Keywords
- stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4)
cyclophosphamideDrug
14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2).
30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3)
Also called CellCept
15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD.
tacrolimusDrug
Also called Prograf, FK-506
0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD.
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Also called Allo HSCT
Patients to received unmanipulated PBSCs on Day 0
peripheral blood stem cell transplantationProcedure or surgery
Also called allogeneic hematopoietic stem cell transplant
patients to receive unmanipulated PBSCs on day 0
| Study group | Role | What they receive |
|---|---|---|
| Myeloablative Haploidentical Transplant | Experimental | All patients will receive treatment using Fludarabine, Busulfan and Cyclophosphamide prior to receiving a haploidentical transplant followed by post-transplant cyclosphosphamide. Receives: Drug: busulfan; Drug: cyclophosphamide; Drug: fludarabine phosphate; Drug: mycophenolate mofetil; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Graft Rejection for Patients at Day 100
Number of patients who experienced graft rejection by Day 100
Measured: Day 100
Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence
Measured: Day 100
Secondary outcomes (9)
Overall Survival at Day 100
Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.
Measured: Day 100
Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.
Measured: 1 year
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Measured: Day 30
Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
Measured: Day 100
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Measured: Day 60
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Measured: Day 90
Overall Survival at 12 Months
Overall survival, defined as a patient being alive after transplant, is without regard to disease status.
Measured: 12 months
Disease Free Survival at 12 Months
Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.
Measured: 12 months
Disease Free Survival at Day 100
Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.
Measured: Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2011
- Study completionApr 2012
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 LeukemiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott R. Solomon, MD, Principal investigator, Blood and Marrow Transplant Group of GeorgiaH. Kent Holland, MD, Principal investigator, Blood and Marrow Transplant Group of GeorgiaAsad Bashey, MD, PhD, Principal investigator, Blood and Marrow Transplant Group of GeorgiaLawrence E. Morris, MD, Principal investigator, Blood and Marrow Transplant Group of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782379
- Sponsor's protocol ID
- CDR0000617648
- Other IDs
- BMTGG-NSH-864
- Status last verified
- Mar 2013
- First submitted
- 29 Oct 2008
- Last updated
- 21 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00782379
- Acronym / sponsor ID
- CDR0000617648
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Keywords
- stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northside Hospital, Inc.University, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.
Detailed description
OBJECTIVES:
Primary
- To estimate the incidence of graft rejection and severe graft-versus-host disease after myeloablative HLA-mismatched peripheral blood stem cell transplantation (PBSCT) from first-degree relatives in patients with high-risk hematologic malignancies.
Secondary
- To estimate overall survival, relapse, non-relapse mortality, and event-free survival in these patients.
- To characterize additional hematologic and non-hematologic toxicities of myeloablative haploidentical PBSCT.
- To characterize donor hematopoietic chimerism in peripheral blood stem cells after PBSCT.
OUTLINE:
- Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -2, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV over 1-2 hours on days -3 and -2.
- Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo infusion of unmanipulated peripheral blood stem cells on day 0.
- Post-transplant regimen: Patients receive high-dose cyclophosphamide IV over 1-2 hours on days 3 and 4, tacrolimus IV over 24 hours or orally twice daily on days 5-180, and oral mycophenolate mofetil 3 times daily on days 5-34 followed by a taper to day 90. Treatment continues in the absence of disease progression or clinically significant graft-vs-host disease.
After completion of PBSCT, patients are followed periodically for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myeloablative Haploidentical Transplant | Experimental | Drug: busulfan, Drug: cyclophosphamide, Drug: fludarabine phosphate, Drug: mycophenolate mofetil, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationAll patients will receive treatment using Fludarabine, Busulfan and Cyclophosphamide prior to receiving a haploidentical transplant followed by post-transplant cyclosphosphamide. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| busulfan110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4) | Drug | Myeloablative Haploidentical Transplant |
| cyclophosphamide14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2). | Drug | Myeloablative Haploidentical Transplant |
| fludarabine phosphate30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3) | Drug | Myeloablative Haploidentical Transplant |
| mycophenolate mofetilAlso: CellCept15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD. | Drug | Myeloablative Haploidentical Transplant |
| tacrolimusAlso: Prograf, FK-5060.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD. | Drug | Myeloablative Haploidentical Transplant |
| allogeneic hematopoietic stem cell transplantationAlso: Allo HSCTPatients to received unmanipulated PBSCs on Day 0 | Procedure or surgery | Myeloablative Haploidentical Transplant |
| peripheral blood stem cell transplantationAlso: allogeneic hematopoietic stem cell transplantpatients to receive unmanipulated PBSCs on day 0 | Procedure or surgery | Myeloablative Haploidentical Transplant |
Primary outcome
Incidence of Graft Rejection for Patients at Day 100
Time frame: Day 100
Number of patients who experienced graft rejection by Day 100
Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
Time frame: Day 100
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence
9 secondary outcomes
Overall Survival at Day 100
Time frame: Day 100
Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
Time frame: 1 year
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
Time frame: Day 30
Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
Time frame: Day 100
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
Time frame: Day 60
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
Time frame: Day 90
Overall Survival at 12 Months
Time frame: 12 months
Disease Free Survival at 12 Months
Time frame: 12 months
Disease Free Survival at Day 100
Time frame: Day 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott R. Solomon, MD principal investigator
Blood and Marrow Transplant Group of Georgia
H. Kent Holland, MD principal investigator
Blood and Marrow Transplant Group of Georgia
Asad Bashey, MD, PhD principal investigator
Blood and Marrow Transplant Group of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing busulfan, cyclophosphamide and fludarabine phosphate in people with Leukemia and Lymphoma, run by Northside Hospital, Inc. 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?
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 21 Nov 2013. 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 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 3 May 2013). 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?
Incidence of Graft Rejection for Patients at Day 100 (time frame: Day 100). 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 21 Nov 2013.