Philadelphia Positive Chronic Myeloid LeukemiaPhase 2NCT00171249
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia
A Phase 2 study testing STI571 400 mg and STI571 600 mg in people with Philadelphia Positive Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Novartis Pharmaceuticals at 12 sites in 5 countries.
Trial summary
The objectives of Part 1 of the study were: To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Positive Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- What is being tested?
- STI571 400 mg and STI571 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 9 Aug 1999to 23 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
- Male or female participants, aged ≥18 years, with a histologically confirmed diagnosis of Ph+ leukemia of one of the following types:
- Accelerated phase chronic myeloid/myelogenous leukemia (CML).
- Acute lymphoid/lymphoblastic leukemia (ALL) or acute myeloid/myelogenous leukemia (AML) in first or subsequent relapse after either standard chemotherapy, autologous or allogeneic bone marrow transplantation, or high-dose treatment with peripheral blood stem cell support, or
- ALL or AML refractory to standard chemotherapy (no complete remission achieved after two courses of conventional induction chemotherapy).
- Lymphoid blastic phase of CML in first or subsequent relapse or refractory to standard chemotherapy.
- With serum serum glutamate oxaloacetate transaminase (aspartate aminotransferase) and serum glutamate pyruvate transaminase (alanine aminotransferase) not more than 3 x upper limit of normal (ULN) (or not more than 5xULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2xULN, and total serum bilirubin level not more than 3xULN (bilirubin limit was 1.5xULN before protocol amendment 1)
Who cannot join
- Participants who had an Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.
- Participants with known leukemic involvement of the central nervous system (CNS).
- Participants who had received treatment with any of the following agents: interferon-alpha within 48 hours, hydroxyurea within 24 hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 or 28 days respectively, 6-mercaptopurine, vinca alkaloids or steroids within 7 days, anthracyclines, mitoxantrone, etoposide, methotrexate, cyclophosphamide within 21 days, or busulfan within 6 weeks.
- Participants who had undergone hematopoietic stem cell transplantation within six weeks of Day 1, or who had not achieved full hematopoietic recovery following the transplant.
- Participants with grade 3/4 cardiac disease or any serious, concomitant, medical condition.
- Participants with a history of non-compliance to medical regimens or who were considered potentially unreliable.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
United States4 sites
Dana Faber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center, University of Texas
Houston, Texas, 77030
New York Presbyterian Hospital
New York, New York, 10021
Oregon Health & Sciences University
Portland, Oregon, 97239
Germany4 sites
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Mainz
Novartis Investigative Site
Mannheim
France2 sites
Novartis Investigative Site
Pessac
Novartis Investigative Site
Poitiers
About this study
Official title: An Extension to a Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Adult Patients With Philadelphia Chromosome Positive Leukemia Including Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Accelerated Phase Chronic Myeloid Leukemia
The objectives of Part 1 of the study were:
- To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP).
- To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment.
The objective of the extension (Part 2) was:
-To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.
- Conditions
- Philadelphia Positive Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Being tested
- STI571 400 mg, STI571 600 mg
- Keywords
- Chronic Myelogenous Leukemia, CML, Philadelphia Chromosome, Accelerated phase, Acute Myelogenous Leukemia, AML, Acute Lymphoblastic Leukemia, ALL, Imatinib mesylate
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI571 400 mgDrug
Also called Imatinib mesylate, Glivec®, GleevecTM
STI571 capsules and tablets
STI571 600 mgDrug
Also called Imatinib mesylate, Glivec®, GleevecTM
STI571 capsules and tablets
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg | Experimental | Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Receives: Drug: STI571 400 mg |
| Lymphoid Blast Crisis 400 mg | Experimental | Participants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Receives: Drug: STI571 400 mg |
| Acute Lymphoblastic Leukemia 400 mg | Experimental | Participants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Receives: Drug: STI571 400 mg |
| Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg | Experimental | Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Receives: Drug: STI571 600 mg |
| Lymphoid Blast Crisis 600 mg | Experimental | Participants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Receives: Drug: STI571 600 mg |
| Acute Lymphoblastic Leukemia 600 mg | Experimental | Participants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Receives: Drug: STI571 600 mg |
| Acute Myeloid/Myelogenous Leukemia 600 mg | Experimental | Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. Receives: Drug: STI571 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC).
Measured: Up to 3 years after start of treatment
Secondary outcomes (6)
Percentage of Participants With Cytogenetic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Bone marrow (BM) cytogenetic analysis was required at baseline, after 12 weeks (visit 22) and after 24 weeks (visit 28) to evaluate Ph chromosome positivity. In several participants, this was also done after 4 and 8 weeks. Based on the percentage of Philadelphia chromosome positive (Ph+) cells = (positive cells/examined cells)x100, at each BM assessment the cytogenetic response was classified as: Complete, 0% Ph+ cells; Partial, >0 - 35% Ph+ cells; Minor, >35 - 65% Ph+ cells; Minimal, >65 - 95% Ph+ cells; None, >95% Ph+ cells; Not done: <20 metaphases were examined and/or response could not be assigned. Cytogenetic response was defined as confirmed complete or partial response. A BM sample was considered as assessable for cytogenetic response only if it contained ≥20 metaphases. However, an assessment of partial response was retained in a sample with <20 metaphases when it was immediately preceded or followed by a complete or partial response in another sample with ≥20 metaphases.
Measured: Up to 3 years after start of treatment
Time to Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Time to response was defined for all participants as the time until first documented response (which was confirmed ≥4 weeks later).
Measured: Up to 3 years after start of treatment
Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Duration of response was defined as the time between first documented response (which was confirmed ≥4 weeks later) and the earliest date of the following: loss of response (when any of the criteria for response were no longer fulfilled); progression to blast crisis (≥30% blasts in peripheral blood or bone marrow, extramedullary involvement other than liver/spleen enlargement); discontinuation due to adverse event, laboratory abnormality, unsatisfactory therapeutic effect or death.
Measured: Up to 3 years after start of treatment
Time to Progression to Blast Crisis in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Progression to blast crisis was defined as ≥30% blasts in peripheral blood or bone marrow or as extramedullary involvement other than liver or spleen enlargement.
Measured: Up to 3 years after start of treatment
Overall Survival by Disease
To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date.
Measured: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 months after start of treatment
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date.
Measured: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start9 Aug 1999
- Primary completion23 Sep 2013
- Study completion23 Sep 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 Philadelphia Positive Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171249
- Sponsor's protocol ID
- CSTI571A0109E2
- Other IDs
- 2005-001381-14, 2005
- Status last verified
- Jul 2021
- First submitted
- 12 Sep 2005
- Last updated
- 22 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension to a Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Adult Patients With Philadelphia Chromosome Positive Leukemia Including Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Accelerated Phase Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00171249
- Acronym / sponsor ID
- CSTI571A0109E2
- Conditions
- Philadelphia Positive Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Keywords
- Chronic Myelogenous Leukemia, CML, Philadelphia Chromosome, Accelerated phase, Acute Myelogenous Leukemia, AML, Acute Lymphoblastic Leukemia, ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 1999 (actual)
- Primary completion
- 23 Sep 2013 (actual)
- Study completion
- 23 Sep 2013 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 22 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of Part 1 of the study were:
- To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP).
- To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment.
The objective of the extension (Part 2) was:
-To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg | Experimental | Drug: STI571 400 mgParticipants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Lymphoid Blast Crisis 400 mg | Experimental | Drug: STI571 400 mgParticipants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Acute Lymphoblastic Leukemia 400 mg | Experimental | Drug: STI571 400 mgParticipants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg | Experimental | Drug: STI571 600 mgParticipants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Lymphoid Blast Crisis 600 mg | Experimental | Drug: STI571 600 mgParticipants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Acute Lymphoblastic Leukemia 600 mg | Experimental | Drug: STI571 600 mgParticipants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
| Acute Myeloid/Myelogenous Leukemia 600 mg | Experimental | Drug: STI571 600 mgParticipants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants, aged ≥18 years, with a histologically confirmed diagnosis of Ph+ leukemia of one of the following types:
- With serum serum glutamate oxaloacetate transaminase (aspartate aminotransferase) and serum glutamate pyruvate transaminase (alanine aminotransferase) not more than 3 x upper limit of normal (ULN) (or not more than 5xULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2xULN, and total serum bilirubin level not more than 3xULN (bilirubin limit was 1.5xULN before protocol amendment 1)
Key exclusion criteria (7 listed)
- Participants who had an Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.
- Participants with known leukemic involvement of the central nervous system (CNS).
- Participants who had received treatment with any of the following agents: interferon-alpha within 48 hours, hydroxyurea within 24 hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 or 28 days respectively, 6-mercaptopurine, vinca alkaloids or steroids within 7 days, anthracyclines, mitoxantrone, etoposide, methotrexate, cyclophosphamide within 21 days, or busulfan within 6 weeks.
- Participants who had undergone hematopoietic stem cell transplantation within six weeks of Day 1, or who had not achieved full hematopoietic recovery following the transplant.
- Participants with grade 3/4 cardiac disease or any serious, concomitant, medical condition.
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 |
|---|---|---|
| STI571 400 mgAlso: Imatinib mesylate, Glivec®, GleevecTMSTI571 capsules and tablets | Drug | Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg, Acute Lymphoblastic Leukemia 400 mg, Lymphoid Blast Crisis 400 mg |
| STI571 600 mgAlso: Imatinib mesylate, Glivec®, GleevecTMSTI571 capsules and tablets | Drug | Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg, Acute Lymphoblastic Leukemia 600 mg, Acute Myeloid/Myelogenous Leukemia 600 mg, Lymphoid Blast Crisis 600 mg |
Primary outcome
Percentage of Participants With Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Time frame: Up to 3 years after start of treatment
Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC).
6 secondary outcomes
Percentage of Participants With Cytogenetic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Time frame: Up to 3 years after start of treatment
Time to Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Time frame: Up to 3 years after start of treatment
Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Time frame: Up to 3 years after start of treatment
Time to Progression to Blast Crisis in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Time frame: Up to 3 years after start of treatment
Overall Survival by Disease
Time frame: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 months after start of treatment
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Time frame: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 months after start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STI571 400 mg and STI571 600 mg in people with Philadelphia Positive Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Novartis Pharmaceuticals at 12 sites in 5 countries.
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 6 inclusion and 7 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, France, Italy, United Kingdom. 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 22 Jul 2021). 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 Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia (time frame: Up to 3 years after start of treatment). 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 22 Jul 2021.