Adult Nasal Type Extranodal NK/T-cell LymphomaPhase 2NCT01419795
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
A Phase 2 study testing lenalidomide, rituximab and pharmacological study in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- lenalidomide, rituximab and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Patients with CLL/SLL/PLL or NHL and who:
- Met the criteria of relapse or progression after allogeneic HCT according to the HCT protocol or the attending discretion and who,
- Not responding to appropriate tapering of immunosuppressive medications
- Absolute neutrophil count (ANC) >= 1500/mm^3 or >= 1000/mm^3 if ANC has persistently < 1500/ mm^3 for more than 2 weeks
Show all 13Show fewer
- Platelet count (transfusion independent) >= 50,000/mm^3 or >= 20,000/mm^3 if platelet count has persistently < 50,000/mm^3 for more than 2 weeks
- Creatinine clearance >= 30ml/min by Cockcroft-Gault formula
- Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if total bilirubin has been persistently > 1.5 x ULN for more than 2 weeks
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x ULN or =< 5 x ULN if AST or ALT have been persistently > 3 x ULN for more than 2 weeks
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
- All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
- Study participants with risk factors for venous thrombo-embolism (VTE), such as previous VTE, cardiac disease, chronic renal insufficiency, and/or poorly controlled diabetes, should be able to comply with some degree of prophylactic anticoagulation using aspirin 81 or 325 mg daily, coumadin, or low molecular weight heparin
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
- Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking lenalidomide)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Known hypersensitivity to thalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Resistance to prior use of lenalidomide, defined as progression on full dose lenalidomide within the first two cycles of therapy
Show all 10Show fewer
- Concurrent use of other anti-cancer agents or treatments
- Known seropositive for or active viral infection with human immunodeficiency virus
- Karnofsky performance status < 50%
- Active grades III or IV acute graft-versus-host disease (GVHD)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase II Study Investigating Treatment of Post-Allogeneic Transplant Progression or Relapse of CLL/SLL/PLL or NHL With Lenalidomide Alone or With Rituximab
This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To improve overall survival in patients with relapse of NHL or CLL/SLL/PLL within 180 days after allogeneic hematopoietic cell transplant (HCT).
SECONDARY OBJECTIVES:
- Rate of response (complete response [CR], partial response [PR], or stable disease [SD]) and time to progression.
II. Grade III-IV toxicity.
III. Incidences of grades II-IV acute graft-versus-host disease (GVHD) and limited or extensive chronic GVHD.
IV. Compare efficacy and safety between the first, second and third cohorts.
- Laboratory research studies for efficacy and toxicity: blood samples will be stored at baseline, day 7, and day 28 of cycle 1 and day 28 of cycle 3 to investigate:
- changes in plasma cytokines and peripheral blood lymphocytes in correlation to treatment with lenalidomide;
- pharmacokinetics of rituximab;
- donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease response and relapse.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide orally (PO) once daily (QD) on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
ARM II: Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 60 days and then every 3 months for up to 18 months.
- Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma
- Being tested
- lenalidomide, rituximab, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Peripheral, Leukemia, Prolymphocytic, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called CC-5013, IMiD-1, Revlimid
Given PO
rituximabBiological
Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8
Given IV
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (lenalidomide, rituximab) | Experimental | Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. Receives: Drug: lenalidomide; Biological: rituximab; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm II (lenalidomide) | Active comparator | Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. Receives: Drug: lenalidomide; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1)
Estimated using the Kaplan-Meier method in all cohorts.
Measured: 12 months
Secondary outcomes (8)
Rate of Response (CR, PR, or SD) and Time to Progression
Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.
Measured: Assessed up to 18 months
Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
Measured: Assessed up to 30 days after completion of study treatment
Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
Measured: Assessed up to 30 days after completion of study treatment
Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts
Measured: Assessed up to 18 months
Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide
Measured: From baseline to day 28 of course 3
Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts
Measured: Assessed up to 30 days after completion of study treatment
Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses
Measured: Baseline, day 7 and 28 of course 1, and day 28 of course 3
Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse
Measured: Baseline, day 7 and 28 of course 1, and day 28 of course 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startMay 2012
- Primary completionSep 2013
Why it stopped: Low accrual
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 Adult Nasal Type Extranodal NK/T-cell LymphomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mohamed Sorror, Fred Hutchinson Cancer Center
- Investigators
- Mohamed Sorror, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419795
- Sponsor's protocol ID
- 2467.00
- Other IDs
- NCI-2011-01703, P30CA015704
- Status last verified
- Jul 2017
- First submitted
- 15 Aug 2011
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Investigating Treatment of Post-Allogeneic Transplant Progression or Relapse of CLL/SLL/PLL or NHL With Lenalidomide Alone or With Rituximab
- ClinicalTrials.gov ID
- NCT01419795
- Acronym / sponsor ID
- 2467.00
- Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 21 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- To improve overall survival in patients with relapse of NHL or CLL/SLL/PLL within 180 days after allogeneic hematopoietic cell transplant (HCT).
SECONDARY OBJECTIVES:
- Rate of response (complete response [CR], partial response [PR], or stable disease [SD]) and time to progression.
II. Grade III-IV toxicity.
III. Incidences of grades II-IV acute graft-versus-host disease (GVHD) and limited or extensive chronic GVHD.
IV. Compare efficacy and safety between the first, second and third cohorts.
- Laboratory research studies for efficacy and toxicity: blood samples will be stored at baseline, day 7, and day 28 of cycle 1 and day 28 of cycle 3 to investigate:
- changes in plasma cytokines and peripheral blood lymphocytes in correlation to treatment with lenalidomide;
- pharmacokinetics of rituximab;
- donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease response and relapse.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide orally (PO) once daily (QD) on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
ARM II: Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 60 days and then every 3 months for up to 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (lenalidomide, rituximab) | Experimental | Drug: lenalidomide, Biological: rituximab, Other: pharmacological study, Other: laboratory biomarker analysisPatients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. |
| Arm II (lenalidomide) | Active comparator | Drug: lenalidomide, Other: pharmacological study, Other: laboratory biomarker analysisPatients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Patients with CLL/SLL/PLL or NHL and who:
- Absolute neutrophil count (ANC) >= 1500/mm^3 or >= 1000/mm^3 if ANC has persistently < 1500/ mm^3 for more than 2 weeks
- Platelet count (transfusion independent) >= 50,000/mm^3 or >= 20,000/mm^3 if platelet count has persistently < 50,000/mm^3 for more than 2 weeks
Key exclusion criteria (10 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
- Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking lenalidomide)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Known hypersensitivity to thalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
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 |
|---|---|---|
| lenalidomideAlso: CC-5013, IMiD-1, RevlimidGiven PO | Drug | Arm I (lenalidomide, rituximab), Arm II (lenalidomide) |
| rituximabAlso: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8Given IV | Biological | Arm I (lenalidomide, rituximab) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (lenalidomide, rituximab), Arm II (lenalidomide) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (lenalidomide, rituximab), Arm II (lenalidomide) |
Primary outcome
Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1)
Time frame: 12 months
Estimated using the Kaplan-Meier method in all cohorts.
8 secondary outcomes
Rate of Response (CR, PR, or SD) and Time to Progression
Time frame: Assessed up to 18 months
Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab
Time frame: Assessed up to 30 days after completion of study treatment
Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD
Time frame: Assessed up to 30 days after completion of study treatment
Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts
Time frame: Assessed up to 18 months
Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide
Time frame: From baseline to day 28 of course 3
Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts
Time frame: Assessed up to 30 days after completion of study treatment
Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses
Time frame: Baseline, day 7 and 28 of course 1, and day 28 of course 3
Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse
Time frame: Baseline, day 7 and 28 of course 1, and day 28 of course 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- 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.
Mohamed Sorror principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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 lenalidomide, rituximab and pharmacological study in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Fred Hutchinson 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 13 inclusion and 10 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: stopped early, as of the sponsor's last update on 27 Jul 2017. 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 21 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1) (time frame: 12 months). 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 27 Jul 2017; AzTrials last refreshed its copy on 1 Nov 2026.