B-cell Lymphoma RefractoryPhase 2TBFNCT01786018
Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas
A Phase 2 study testing Thiotepa, Busulfan and Fludarabin in people with B-cell Lymphoma Refractory, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- B-cell Lymphoma Refractory
- What is being tested?
- Thiotepa, Busulfan and Fludarabin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Feb 2015
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient inclusion criteria:
- Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
- Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
- Patients younger than 65 years old
- A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
- Patient must be competent to give consent.
Patient exclusion criteria:
- Patients treated with an autologous transplant as salvage therapy
- Patients with progressive lymphomas despite conventional therapies
- Patients with progressive lymphomas despite conventional therapies
- Uncontrolled CNS involvement with disease
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Females who are pregnant or breastfeeding
- Organ dysfunction defined as follows:
- Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
- Pulmonary: DLCO <40% predicted
- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
- Renal: creatinine clearance <50 cc/min (24 hour urine collection)
- Karnofsky performance score < 60%
- Patients with poorly controlled hypertension despite multiple antihypertensives
- Documented fungal disease that is progressive despite treatment
- Viral infections: HIV positive patients.
- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
- Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
- Patients with active non-hematologic malignancies (except non-melanoma skin cancers).
- Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence.
Donor inclusion criteria:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLA-mismatched (9/10 match) donors will also be considered.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 mg/kg of body weight.
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian).
Donor exclusion criteria:
- Age < 18 years.
- Identical twin.
- Pregnancy.
- Infection with HIV.
- Inability to achieve adequate venous access.
- Known allergy to filgrastin (G-CSF).
- Current serious systemic illness.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Città della Salute e della Scienza di Torino
Torino, 10126
Benedetto Bruno, MD, +390116336728, benedetto.bruno@unito.it
About this study
Official title: Allogeneic Transplantation After a Conditioning With Thiotepa, Busulfan and Fludarabin for the Treatment of Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas: a Phase II Multi-Center Trial
The purpose of this study is to evaluate progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.
Read the detailed description
In the present study, it is hypothesised that patients with aggressive B cell lymphomas refractory to or relapsed early (within 12 months) after the completion of standard first-line immunoProtocol TBF2012 Version 1, 20 Nov 2012 9 chemotherapy can benefit from de-bulking salvage therapy (i.e. R-DHAP + bortezomib) followed by an allograft to improve progression-free survival.
Patient inclusion criteria
- Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
- Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
- Patients younger than 65 years old
- A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
- Patient must be competent to give consent
Patient exclusion criteria
- Patients treated with an autologous transplant as salvage therapy
- Patients with progressive lymphomas despite conventional therapies
- Patients with progressive lymphomas despite conventional therapies
- Uncontrolled CNS involvement with disease
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Females who are pregnant or breastfeeding
- Organ dysfunction defined as follows:
- Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
- Pulmonary: DLCO <40% predicted
- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4 the upper limit of normal
- Renal: creatinine clearance <50 cc/min (24 hour urine Protocol TBF2012 Version 1, 20 Nov 2012 6 collection)
- Karnofsky performance score < 60%
- Patients with poorly controlled hypertension despite multiple antihypertensives
- Documented fungal disease that is progressive despite treatment
- Viral infections: HIV positive patients.
- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
- Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
- Patients with active non-hematologic malignancies (except nonmelanoma skin cancers).
- Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence. Donor inclusion criteria:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
- Age < 18 years.
- Identical twin.
- Pregnancy.
- Infection with HIV.
- Inability to achieve adequate venous access.
- Known allergy to filgrastin (G-CSF).
- Current serious systemic illness.
Donor inclusion criteria:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
- Age < 18 years.
- Identical twin.
- Pregnancy.
- Infection with HIV.
- Inability to achieve adequate venous access.
- Known allergy to filgrastin (G-CSF).
- Current serious systemic illness.
Donor inclusion criteria:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
- Age < 18 years.
- Identical twin.
- Pregnancy.
- Infection with HIV.
- Inability to achieve adequate venous access.
- Known allergy to filgrastin (G-CSF).
- Current serious systemic illness.
- Conditions
- B-cell Lymphoma Refractory
- Keywords
- Non Hodgkin lymphomas, Allogeneic Transplantation, Thiotepa, Busulfan, Fludarabin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiotepaDrug
Also called TEPADINA®
BusulfanDrug
Also called BUSILVEX®
FludarabinDrug
Also called FLUDARA®
transplant (HCT)Procedure or surgery
Transplant will be PBSCs collected as per institutional standard. A portion of the PBSC product will be removed for DLI that is equivalent to 3x10^7 CD3 cells/kg recipient weight and cryopreserved.
CytoreductionRadiation
Cytoreduction and /or radiation therapy will be given by the referring physician or the attending physician as determined on clinical grounds or to meet eligibility requirements of the protocol for patients with advanced malignancy or to reduce tumor bulk. However, no intensive chemotherapy can be given within three weeks before conditioning.
ImmunosuppressionDrug
Day -3. Commence cyclosporine at 5.0 mg/kg PO Q12 hours, continue to day +50 and then taper by 5% per week until day +180.
CyclosporineDrug
CSP is given based on adjusted body weight, at 5.0 mg/kg PO q12 hours from day -3.
If there is nausea and vomiting at anytime during CSP treatment the drug should be given intravenously at the appropriate dose that was used to obtain a therapeutic level.
See guidelines for PO to IV conversion below.
MethotrexateDrug
Day 1 15 mg Days 3, 6, 11 10 mg m2 day IV for GVHD prevention
ATGDrug
Also called Anti-Human Thymocyte Globulin
(FOR UNRELATED TRANSPLANTS ONLY) Days -3, -2: 2.5 mg /kg/day
Collection and infusions of Donor PBSCProcedure or surgery
Collection and infusions of Donor PBSC
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
* Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
* Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2) Receives: Drug: Thiotepa; Drug: Busulfan; Drug: Fludarabin; Procedure: transplant (HCT); Radiation: Cytoreduction; Drug: Immunosuppression; Drug: Cyclosporine; Drug: Methotrexate; Drug: ATG; Procedure: Collection and infusions of Donor PBSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 2 years
Secondary outcomes (3)
Transplant-related morbidity (TRM) at day +100 and at +365
Measured: 1 year
Overall survival
Measured: 2 years
Incidence of acute and chronic GVHD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Lymphoma RefractoryStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedetto Bruno, Azienda Ospedaliera San Giovanni Battista
- Investigators
- Benedetto Bruno, MD, Principal investigator, Divisione di Ematologia-Città della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786018
- Sponsor's protocol ID
- TBF2012
- Acronym
- TBF
- Status last verified
- Jul 2014
- First submitted
- 5 Feb 2013
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Transplantation After a Conditioning With Thiotepa, Busulfan and Fludarabin for the Treatment of Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas: a Phase II Multi-Center Trial
- ClinicalTrials.gov ID
- NCT01786018
- Acronym / sponsor ID
- TBF / TBF2012
- Conditions
- B-cell Lymphoma Refractory
- Keywords
- Non Hodgkin lymphomas, Allogeneic Transplantation, Thiotepa, Busulfan, Fludarabin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 7 Feb 2013 (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 purpose of this study is to evaluate progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.
Detailed description
In the present study, it is hypothesised that patients with aggressive B cell lymphomas refractory to or relapsed early (within 12 months) after the completion of standard first-line immunoProtocol TBF2012 Version 1, 20 Nov 2012 9 chemotherapy can benefit from de-bulking salvage therapy (i.e. R-DHAP + bortezomib) followed by an allograft to improve progression-free survival.
Patient inclusion criteria
- Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
- Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
- Patients younger than 65 years old
- A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
- Patient must be competent to give consent
Patient exclusion criteria
- Patients treated with an autologous transplant as salvage therapy
- Patients with progressive lymphomas despite conventional therapies
- Patients with progressive lymphomas despite conventional therapies
- Uncontrolled CNS involvement with disease
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Females who are pregnant or breastfeeding
- Organ dysfunction defined as follows:
- Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
- Pulmonary: DLCO <40% predicted
- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4 the upper limit of normal
- Renal: creatinine clearance <50 cc/min (24 hour urine Protocol TBF2012 Version 1, 20 Nov 2012 6 collection)
- Karnofsky performance score < 60%
- Patients with poorly controlled hypertension despite multiple antihypertensives
- Documented fungal disease that is progressive despite treatment
- Viral infections: HIV positive patients.
- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
- Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
- Patients with active non-hematologic malignancies (except nonmelanoma skin cancers).
- Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence. Donor inclusion criteria:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
- Age < 18 years.
- Identical twin.
- Pregnancy.
- Infection with HIV.
- Inability to achieve adequate venous access.
- Known allergy to filgrastin (G-CSF).
- Current serious systemic illness.
Donor inclusion criteria:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
- Age < 18 years.
- Identical twin.
- Pregnancy.
- Infection with HIV.
- Inability to achieve adequate venous access.
- Known allergy to filgrastin (G-CSF).
- Current serious systemic illness.
Donor inclusion criteria:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
- Age < 18 years.
- Identical twin.
- Pregnancy.
- Infection with HIV.
- Inability to achieve adequate venous access.
- Known allergy to filgrastin (G-CSF).
- Current serious systemic illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Thiotepa, Drug: Busulfan, Drug: Fludarabin, Procedure: transplant (HCT), Radiation: Cytoreduction, Drug: Immunosuppression, Drug: Cyclosporine, Drug: Methotrexate, Drug: ATG, Procedure: Collection and infusions of Donor PBSC* Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg) * Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg) * Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| ThiotepaAlso: TEPADINA® | Drug | 1 |
| BusulfanAlso: BUSILVEX® | Drug | 1 |
| FludarabinAlso: FLUDARA® | Drug | 1 |
| transplant (HCT)Transplant will be PBSCs collected as per institutional standard. A portion of the PBSC product will be removed for DLI that is equivalent to 3x10^7 CD3 cells/kg recipient weight and cryopreserved. | Procedure or surgery | 1 |
| CytoreductionCytoreduction and /or radiation therapy will be given by the referring physician or the attending physician as determined on clinical grounds or to meet eligibility requirements of the protocol for patients with advanced malignancy or to reduce tumor bulk. However, no intensive chemotherapy can be given within three weeks before conditioning. | Radiation | 1 |
| ImmunosuppressionDay -3. Commence cyclosporine at 5.0 mg/kg PO Q12 hours, continue to day +50 and then taper by 5% per week until day +180. | Drug | 1 |
| CyclosporineCSP is given based on adjusted body weight, at 5.0 mg/kg PO q12 hours from day -3. If there is nausea and vomiting at anytime during CSP treatment the drug should be given intravenously at the appropriate dose that was used to obtain a therapeutic level. See guidelines for PO to IV conversion below. | Drug | 1 |
| MethotrexateDay 1 15 mg Days 3, 6, 11 10 mg m2 day IV for GVHD prevention | Drug | 1 |
| ATGAlso: Anti-Human Thymocyte Globulin(FOR UNRELATED TRANSPLANTS ONLY) Days -3, -2: 2.5 mg /kg/day | Drug | 1 |
| Collection and infusions of Donor PBSCCollection and infusions of Donor PBSC | Procedure or surgery | 1 |
Primary outcome
Progression free survival
Time frame: 2 years
3 secondary outcomes
Transplant-related morbidity (TRM) at day +100 and at +365
Time frame: 1 year
Overall survival
Time frame: 2 years
Incidence of acute and chronic GVHD
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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.
Benedetto Bruno, MD principal investigator
Divisione di Ematologia-Città della Salute e della Scienza di Torino
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 Thiotepa, Busulfan and Fludarabin in people with B-cell Lymphoma Refractory, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 8 Jul 2014. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedetto Bruno, MD (+390116336728, benedetto.bruno@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2 years). 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 Jul 2014.