Follicular LymphomaNCT02316613
Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)
An observational study of Follicular Lymphoma, run by Hoffmann-La Roche at 1 site in France.
Trial summary
This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Rituximab
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to Apr 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment of approximately 90 physicians who treat patients with follicular non-Hodgkin's lymphoma to actively participate in this observational study. Patients with relapsed or refractory follicular non-Hodgkin's lymphoma (World Health Organization grade 1-3) and requiring treatment are to be enrolled prospectively. Subgroup of interest: patients receiving MabThera® (rituximab) maintenance therapy.
Who may be able to join
- Adult patient (age >/= 18 years)
- Presenting with WHO grade 1-3, CD20-positive follicular non-Hodgkin's lymphoma, histologically confirmed at initial diagnosis
- In relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy
- Having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data
Who cannot join
- Patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion
- Follicular lymphoma presenting with a transformation to diffuse large cell non-Hodgkin's lymphoma
- First line treatment with radiotherapy alone
- Initial abstention from treatment (decision to not treat the progression at the time of inclusion in the OLYMPE study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma
This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.
- Conditions
- Follicular Lymphoma
- Being tested
- Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called MabThera®
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. All participants received at least one cycle of rituximab (MabThera) during maintenance therapy or observation period. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.
Measured: Baseline
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.
Measured: Induction Phase: 18.7 months
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase
Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.
Measured: Induction Phase: 18.7 months
Percentage of Participants With MabThera as Maintenance Therapy
During the maintenance period participants received four weekly infusion of MabThera.
Measured: Maintenance/observation Phase: 67.8 months
Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase
After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.
Measured: Maintenance/observation Phase: 67.8 months
Duration of MabThera Maintenance Therapy When Associated With Observation
Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.
Measured: Maintenance/observation Phase: 67.8 months
Percentage of Participants With Prescription of Injection Prophylaxis
Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.
Measured: Maintenance/observation Phase: 67.8 months
Percentage of Participants With Injection Prophylaxis Treatment
Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.
Measured: Maintenance/observation Phase: 67.8 months
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression
The therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.
Measured: Up to 6 years
Number of Participants With Therapeutic Management After the First Study Disease Progression
After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.
Measured: Up to 6 years
Secondary outcomes (14)
Percentage of Participants With Last Induction Treatment Response
Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.
Measured: Induction Phase: 18.7 months
Percentage of Participants With Number of Disease Progressions
Participants with at least one disease progression after the first study induction period were reported.
Measured: Up to 6 years
Percentage of Participants With Disease Characteristics at First Study Disease Progression
Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).
Measured: Up to 6 years
Progression Free Survival (PFS)
The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.
Measured: Up to 6 years
Time to Next Treatment
Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.
Measured: Up to 6 years
Overall Survival (OS)
The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.
Measured: Up to 6 years
Number of Participants Who Used MabThera
Measured: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Dose of MabThera
All participants who received MabThera treatment before the first disease progression were reported.
Measured: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Infusion Duration
Measured: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Number of Cycles of MabThera
Measured: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Time Between Cycles
Measured: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase
Measured: Maintenance phase : 67.8 months
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score
The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much"). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items.
Measured: Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])
Number and Type of Hospitalization Associated With MabThera Perfusion
Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startFeb 2007
- Primary completionApr 2013
- Study completionApr 2013
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 Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316613
- Sponsor's protocol ID
- ML20248
- Status last verified
- Jan 2016
- First submitted
- 28 Nov 2014
- Last updated
- 25 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT02316613
- Acronym / sponsor ID
- ML20248
- Conditions
- Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Posted 25 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: RituximabParticipants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. All participants received at least one cycle of rituximab (MabThera) during maintenance therapy or observation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of approximately 90 physicians who treat patients with follicular non-Hodgkin's lymphoma to actively participate in this observational study. Patients with relapsed or refractory follicular non-Hodgkin's lymphoma (World Health Organization grade 1-3) and requiring treatment are to be enrolled prospectively. Subgroup of interest: patients receiving MabThera® (rituximab) maintenance therapy.
Key inclusion criteria (4 listed)
- Adult patient (age >/= 18 years)
- Presenting with WHO grade 1-3, CD20-positive follicular non-Hodgkin's lymphoma, histologically confirmed at initial diagnosis
- In relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy
- Having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data
Key exclusion criteria (4 listed)
- Patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion
- Follicular lymphoma presenting with a transformation to diffuse large cell non-Hodgkin's lymphoma
- First line treatment with radiotherapy alone
- Initial abstention from treatment (decision to not treat the progression at the time of inclusion in the OLYMPE study)
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 |
|---|---|---|
| RituximabAlso: MabThera® | Drug | All Participants |
Primary outcome
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
Time frame: Baseline
At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
Time frame: Induction Phase: 18.7 months
Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase
Time frame: Induction Phase: 18.7 months
Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.
Percentage of Participants With MabThera as Maintenance Therapy
Time frame: Maintenance/observation Phase: 67.8 months
During the maintenance period participants received four weekly infusion of MabThera.
Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase
Time frame: Maintenance/observation Phase: 67.8 months
After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.
Duration of MabThera Maintenance Therapy When Associated With Observation
Time frame: Maintenance/observation Phase: 67.8 months
Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.
Percentage of Participants With Prescription of Injection Prophylaxis
Time frame: Maintenance/observation Phase: 67.8 months
Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.
Percentage of Participants With Injection Prophylaxis Treatment
Time frame: Maintenance/observation Phase: 67.8 months
Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression
Time frame: Up to 6 years
The therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.
Number of Participants With Therapeutic Management After the First Study Disease Progression
Time frame: Up to 6 years
After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.
14 secondary outcomes
Percentage of Participants With Last Induction Treatment Response
Time frame: Induction Phase: 18.7 months
Percentage of Participants With Number of Disease Progressions
Time frame: Up to 6 years
Percentage of Participants With Disease Characteristics at First Study Disease Progression
Time frame: Up to 6 years
Progression Free Survival (PFS)
Time frame: Up to 6 years
Time to Next Treatment
Time frame: Up to 6 years
Overall Survival (OS)
Time frame: Up to 6 years
Number of Participants Who Used MabThera
Time frame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Dose of MabThera
Time frame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Infusion Duration
Time frame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Number of Cycles of MabThera
Time frame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Time Between Cycles
Time frame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase
Time frame: Maintenance phase : 67.8 months
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score
Time frame: Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])
Number and Type of Hospitalization Associated With MabThera Perfusion
Time frame: Up to 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- 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.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by Hoffmann-La Roche at 1 site in France.
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 4 inclusion and 4 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 25 Feb 2016. 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 France. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2016). 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?
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase (time frame: Baseline). The study lists 10 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 25 Feb 2016.