Acute Myeloid LeukemiaPhase 2NCT04326439
AflacLL1901 (CHOA-AML)
A Phase 2 study testing Cytarabine, Daunorubicin and Erwinase in people with Acute Myeloid Leukemia and AML, Childhood, run by Emory University at 1 site in United States.
Trial summary
The investigators propose to study an Aflac-AML chemotherapy backbone prospectively to validate its use in all pediatric AML and to further evaluate the cardiotoxicity with this approach for low risk AML. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Acute Myeloid Leukemia, AML, Childhood
- What is being tested?
- Cytarabine, Daunorubicin and Erwinase
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 15 Mar 2022
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: Patients must be less than 21 years of age at the time of study enrollment
- Diagnosis: Patients must be newly diagnosed with AML
- Patients with previously untreated primary AML who meet the customary criteria for AML with ≥ 20% bone marrow blasts as set out in the 2016 WHO Myeloid Neoplasm Classification are eligible.
- Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive. In cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis.
- Patients with <20% bone marrow blasts are eligible if they have:
- A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities,
Show all 9Show fewer
- the unequivocal presence of megakaryoblasts, or
- Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)
- Performance Level: Patients with acceptable organ function and any performance status are eligible for enrollment
Who cannot join
- Patients with any of the following constitutional conditions are not eligible:
- Fanconi anemia
- Shwachman syndrome
- Any other known bone marrow failure syndrome
- Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Note: Enrollment may occur, pending results of clinically indicated studies to exclude these conditions.
- Other Excluded Conditions:
Show all 13Show fewer
- Any concurrent malignancy
- Juvenile myelomonocytic leukemia (JMML)
- Philadelphia chromosome positive AML
- Biphenotypic or bilineal acute leukemia
- Acute promyelocytic leukemia (APL)
- Acute myeloid leukemia arising from myelodysplasia
- Therapy-related myeloid neoplasms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CHOA-AML: A Pilot Study for Newly Diagnosed Pediatric Patients With Acute Myeloid Leukemia (AML)
The investigators propose to study an Aflac-AML chemotherapy backbone prospectively to validate its use in all pediatric AML and to further evaluate the cardiotoxicity with this approach for low risk AML.
Read the detailed description
Advances in risk stratification and therapy, have improved the event-free survival (EFS) and overall survival (OS) for pediatric acute myeloid leukemia (AML) to approximately 50% and 65% respectively, with current treatment strategies. Patients with good response to induction and/or those who lack high-risk cytogenetic and molecular features [classified as low-risk AML (LR-AML)] have even better outcomes with EFS and OS approaching 70% and 85% respectively; however, treatment-related toxicities remain a major concern. Anthracycline-based therapeutic regimens expose patients to the risk of anthracycline-induced cardiotoxicity. Therefore, strategies that reduce cardiac toxicities using tailored approaches while maintaining and/or improving outcomes are needed for all patients with AML. The Children's Oncology Group (COG) regimens AAML1031 and AAML0531 utilized an anthracycline-intensive backbone for LR-AML with cumulative anthracycline doxorubicin-equivalent doses of up to 492mg/m2. However, high-risk patients treated with chemotherapy alone received an intensified induction chemotherapy (using mitoxantrone-cytarabine) but with overall reduced doses of anthracycline-equivalent (342mg/m2). The investigators piloted an institutional practice to treat all LR-AML patients with four cycle regimen (Aflac-AML) with the goal of reducing cumulative anthracycline exposure, thereby reducing the risk of cardiotoxicity, while providing three high-dose cytarabine courses. In this pilot institutional experience with this approach, they were able to maintain excellent outcomes for this low-risk group with 3-year event-free survival (EFS) and OS of 70.0% ± 0.1% and 85.5% ± 0.08% respectively, from end of course 1. Recent evolution in cytogenetic classification has further delineated risk groups in AML. Gemtuzumab ozogamicin (GO), an antibody-drug conjugate was shown to reduce relapse risk in patients with CC genotype with de-novo AML on COG study AAML0531. The investigators propose to study an Aflac-AML chemotherapy backbone prospectively to validate its use in all pediatric AML and to further evaluate the cardiotoxicity with this approach for low risk AML.
- Conditions
- Acute Myeloid Leukemia, AML, Childhood
- Being tested
- Cytarabine, Daunorubicin, Erwinase, Etoposide, Gemtuzumab ozogamicin
- Keywords
- acute myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
Also called cytosine arabinoside, ARA-C
100 mg/m²/dose every 12 hours IV Days 1-10
DaunorubicinDrug
Also called Rubidomycin
50 mg/m²/dose IV Days 1, 3, 5
ErwinaseDrug
Also called Erwinaze, Erwinia L-Asparaginase, Erwinia Chrysanthemi L-asparaginase, Crisantaspase
25,000 International Units/m²/dose IM Days 2, 9
EtoposideDrug
Also called VePesid, VP-16
150 mg/m²/dose IV Days 1-5
Gemtuzumab ozogamicinDrug
Also called Mylotarg®, CDP-771, CMA-676, hP67.6-calicheamicin
Administered as a single 3 mg/m2 dose of GO to be given between days 6-10 during Induction I for patients with CC genotype, in addition to ADE therapy.
Stem cell transplantation (SCT)Procedure or surgery
Also called Hematopoietic stem cell transplantation (HSCT), Bone Marrow Transplant (BMT)
Transplantation of multipotent hematopoietic stem cells from bone marrow
SorafenibDrug
Also called BAY 43-9006 Tosylate, BAY 54-9085 Nexavar
200 mg/m2/dose daily, rounded to accommodate tablet size. The maximum dose will be 400 mg. Days 7 through 34.
| Study group | Role | What they receive |
|---|---|---|
| Aflac-AML Regimen for Low Risk AML Patients | Experimental | Participants in this arm will receive the standard Aflac-AML Regimen with the following chemotherapy:
* Induction-1: patients on Induction-I will receive gemtuzumab + ADE therapy based on genotyping. Lasts a total of 28 days.
* Induction II - MA
* Intensification I - AE
* Intensification II - HD ARAC/LASP
Patients with low risk status who had low risk markers and were MRD positive at the end of Induction I and continue to be MRD positive after Induction II will come off protocol. Receives: Drug: Cytarabine; Drug: Daunorubicin; Drug: Erwinase; Drug: Etoposide; Drug: Gemtuzumab ozogamicin |
| Aflac-AML Regimen for High Risk AML Patients | Experimental | Participants in this arm will receive standard Aflac-AML Regimen with the following chemotherapy:
* Induction-1: patients will receive gemtuzumab in addition to ADE therapy based on genotyping. Induction I lasts a total of 28 days.
* Induction 1 for FLT3-ITD patients - ADE (10+3+5) with GO with Sorafenib
* Induction II - MA
* Induction II for FLT3-ITD patients - MA with Sorafenib
* Intensification I - AE
* Intensification I for FLT3-ITD patients - AE with sorafenib
* Intensification II - HD ARAC/LASP
* Intensification II for FLT3-ITD patients - HD ARAC/LASP with sorafenib
* Hematopoietic stem cell transplantation (HSCT)
If a patient is classified as High risk after Induction I, they may proceed to best allogenic donor SCT following Induction II. These patients may receive a third course of chemotherapy prior to HSCT. In cases where HSCT is not an option, patients can receive 4 cycles of chemotherapy. Only patients with FLT3-ITD mutation will receive sorafenib. Receives: Drug: Cytarabine; Drug: Daunorubicin; Drug: Erwinase; Drug: Etoposide; Drug: Gemtuzumab ozogamicin; Procedure: Stem cell transplantation (SCT); Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS) in Low Risk Patients and High Risk Patients
Event-free survival defined as the time from on study to death, failure to achieve remission or relapse in newly diagnosed patients with pediatric acute myeloid leukemia in the Low risk stratification group and High risk stratification group
Measured: Up to 2 years post-intervention
Secondary outcomes (6)
Overall Survival (OS)
Time from study entry and from end of first course of therapy for newly diagnosed patients with pediatric acute myeloid leukemia
Measured: Up to 2 years post-intervention
Minimal Residual Disease (MRD) Negative Status
Number of patients that are in remission (MRD negative) after course 1 in participants receiving GO and those that did not receive GO.
Measured: Post-induction I, an average of 28 days
Disease-free Survival (DFS) for Patients Who Are MRD Negative
Disease-free survival for patients who are MRD negative but lack high or low risk molecular and cytogenetic features, defined as time from end of first course of therapy to death or relapse
Measured: Up to 2 years post-intervention
Cardiotoxicity in Patients With de Novo AML That Receive the Four-cycle Aflac-AML Regimen With the Inclusion of Dexrazoxane
Number of patients that develop cardiac ejection fraction <50% (CTCAE V5.0 grade 2 or greater dysfunction) either during therapy (early cardiotoxicity) or after completion of therapy (late cardiotoxicity)
Measured: At completion of Cycle 4 (each cycle average is 28 days)
Proportion of Patients Who Develop Infection and/or Febrile Neutropenia During Each Treatment Course
Number of participants that developed infection and/or febrile neutropenia at the end of each treatment cycle.
Measured: At the end of each cycle (each cycle average is 28 days)
Duration of Hospital Admission in Patients That Developed Infection and Febrile Neutropenia at the End of Each Treatment Cycle
Duration of hospital admission in patients that developed infection and febrile neutropenia at the end of each treatment cycle
Measured: At the end of each cycle (each cycle average is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start24 Jan 2020
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Why it stopped: Due to unforeseen circumstances, the study team was limited in enrolling patients on this trial; thus, it was terminated.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Himalee Sabnis, Emory University
- Investigators
- Himalee Sabnis, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326439
- Sponsor's protocol ID
- IRB00111627
- Status last verified
- May 2022
- First submitted
- 13 Mar 2020
- Last updated
- 15 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabnis HS, Minson KA, Monroe C, Allen K, Metts JL, Cooper TM, Woods WG, Castellino SM, Keller FG. A strategy to reduce cumulative anthracycline exposure in low-risk pediatric acute myeloid leukemia while maintaining favorable outcomes. Leuk Res. 2020 Sep;96:106421. doi: 10.1016/j.leukres.2020.106421. Epub 2020 Jul 12.
PubMed 32683126
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOA-AML: A Pilot Study for Newly Diagnosed Pediatric Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT04326439
- Acronym / sponsor ID
- IRB00111627
- Conditions
- Acute Myeloid Leukemia, AML, Childhood
- Keywords
- acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to unforeseen circumstances, the study team was limited in enrolling patients on this trial; thus, it was terminated.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Posted 15 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to study an Aflac-AML chemotherapy backbone prospectively to validate its use in all pediatric AML and to further evaluate the cardiotoxicity with this approach for low risk AML.
Detailed description
Advances in risk stratification and therapy, have improved the event-free survival (EFS) and overall survival (OS) for pediatric acute myeloid leukemia (AML) to approximately 50% and 65% respectively, with current treatment strategies. Patients with good response to induction and/or those who lack high-risk cytogenetic and molecular features [classified as low-risk AML (LR-AML)] have even better outcomes with EFS and OS approaching 70% and 85% respectively; however, treatment-related toxicities remain a major concern. Anthracycline-based therapeutic regimens expose patients to the risk of anthracycline-induced cardiotoxicity. Therefore, strategies that reduce cardiac toxicities using tailored approaches while maintaining and/or improving outcomes are needed for all patients with AML. The Children's Oncology Group (COG) regimens AAML1031 and AAML0531 utilized an anthracycline-intensive backbone for LR-AML with cumulative anthracycline doxorubicin-equivalent doses of up to 492mg/m2. However, high-risk patients treated with chemotherapy alone received an intensified induction chemotherapy (using mitoxantrone-cytarabine) but with overall reduced doses of anthracycline-equivalent (342mg/m2). The investigators piloted an institutional practice to treat all LR-AML patients with four cycle regimen (Aflac-AML) with the goal of reducing cumulative anthracycline exposure, thereby reducing the risk of cardiotoxicity, while providing three high-dose cytarabine courses. In this pilot institutional experience with this approach, they were able to maintain excellent outcomes for this low-risk group with 3-year event-free survival (EFS) and OS of 70.0% ± 0.1% and 85.5% ± 0.08% respectively, from end of course 1. Recent evolution in cytogenetic classification has further delineated risk groups in AML. Gemtuzumab ozogamicin (GO), an antibody-drug conjugate was shown to reduce relapse risk in patients with CC genotype with de-novo AML on COG study AAML0531. The investigators propose to study an Aflac-AML chemotherapy backbone prospectively to validate its use in all pediatric AML and to further evaluate the cardiotoxicity with this approach for low risk AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflac-AML Regimen for Low Risk AML Patients | Experimental | Drug: Cytarabine, Drug: Daunorubicin, Drug: Erwinase, Drug: Etoposide, Drug: Gemtuzumab ozogamicinParticipants in this arm will receive the standard Aflac-AML Regimen with the following chemotherapy: * Induction-1: patients on Induction-I will receive gemtuzumab + ADE therapy based on genotyping. Lasts a total of 28 days. * Induction II - MA * Intensification I - AE * Intensification II - HD ARAC/LASP Patients with low risk status who had low risk markers and were MRD positive at the end of Induction I and continue to be MRD positive after Induction II will come off protocol. |
| Aflac-AML Regimen for High Risk AML Patients | Experimental | Drug: Cytarabine, Drug: Daunorubicin, Drug: Erwinase, Drug: Etoposide, Drug: Gemtuzumab ozogamicin, Procedure: Stem cell transplantation (SCT), Drug: SorafenibParticipants in this arm will receive standard Aflac-AML Regimen with the following chemotherapy: * Induction-1: patients will receive gemtuzumab in addition to ADE therapy based on genotyping. Induction I lasts a total of 28 days. * Induction 1 for FLT3-ITD patients - ADE (10+3+5) with GO with Sorafenib * Induction II - MA * Induction II for FLT3-ITD patients - MA with Sorafenib * Intensification I - AE * Intensification I for FLT3-ITD patients - AE with sorafenib * Intensification II - HD ARAC/LASP * Intensification II for FLT3-ITD patients - HD ARAC/LASP with sorafenib * Hematopoietic stem cell transplantation (HSCT) If a patient is classified as High risk after Induction I, they may proceed to best allogenic donor SCT following Induction II. These patients may receive a third course of chemotherapy prior to HSCT. In cases where HSCT is not an option, patients can receive 4 cycles of chemotherapy. Only patients with FLT3-ITD mutation will receive sorafenib. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age: Patients must be less than 21 years of age at the time of study enrollment
- Diagnosis: Patients must be newly diagnosed with AML
- Patients with previously untreated primary AML who meet the customary criteria for AML with ≥ 20% bone marrow blasts as set out in the 2016 WHO Myeloid Neoplasm Classification are eligible.
- Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive. In cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis.
- Patients with <20% bone marrow blasts are eligible if they have:
Key exclusion criteria (13 listed)
- Patients with any of the following constitutional conditions are not eligible:
- Other Excluded Conditions:
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 |
|---|---|---|
| CytarabineAlso: cytosine arabinoside, ARA-C100 mg/m²/dose every 12 hours IV Days 1-10 | Drug | Aflac-AML Regimen for High Risk AML Patients, Aflac-AML Regimen for Low Risk AML Patients |
| DaunorubicinAlso: Rubidomycin50 mg/m²/dose IV Days 1, 3, 5 | Drug | Aflac-AML Regimen for High Risk AML Patients, Aflac-AML Regimen for Low Risk AML Patients |
| ErwinaseAlso: Erwinaze, Erwinia L-Asparaginase, Erwinia Chrysanthemi L-asparaginase, Crisantaspase25,000 International Units/m²/dose IM Days 2, 9 | Drug | Aflac-AML Regimen for High Risk AML Patients, Aflac-AML Regimen for Low Risk AML Patients |
| EtoposideAlso: VePesid, VP-16150 mg/m²/dose IV Days 1-5 | Drug | Aflac-AML Regimen for High Risk AML Patients, Aflac-AML Regimen for Low Risk AML Patients |
| Gemtuzumab ozogamicinAlso: Mylotarg®, CDP-771, CMA-676, hP67.6-calicheamicinAdministered as a single 3 mg/m2 dose of GO to be given between days 6-10 during Induction I for patients with CC genotype, in addition to ADE therapy. | Drug | Aflac-AML Regimen for High Risk AML Patients, Aflac-AML Regimen for Low Risk AML Patients |
| Stem cell transplantation (SCT)Also: Hematopoietic stem cell transplantation (HSCT), Bone Marrow Transplant (BMT)Transplantation of multipotent hematopoietic stem cells from bone marrow | Procedure or surgery | Aflac-AML Regimen for High Risk AML Patients |
| SorafenibAlso: BAY 43-9006 Tosylate, BAY 54-9085 Nexavar200 mg/m2/dose daily, rounded to accommodate tablet size. The maximum dose will be 400 mg. Days 7 through 34. | Drug | Aflac-AML Regimen for High Risk AML Patients |
Primary outcome
Event-free Survival (EFS) in Low Risk Patients and High Risk Patients
Time frame: Up to 2 years post-intervention
Event-free survival defined as the time from on study to death, failure to achieve remission or relapse in newly diagnosed patients with pediatric acute myeloid leukemia in the Low risk stratification group and High risk stratification group
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to 2 years post-intervention
Minimal Residual Disease (MRD) Negative Status
Time frame: Post-induction I, an average of 28 days
Disease-free Survival (DFS) for Patients Who Are MRD Negative
Time frame: Up to 2 years post-intervention
Cardiotoxicity in Patients With de Novo AML That Receive the Four-cycle Aflac-AML Regimen With the Inclusion of Dexrazoxane
Time frame: At completion of Cycle 4 (each cycle average is 28 days)
Proportion of Patients Who Develop Infection and/or Febrile Neutropenia During Each Treatment Course
Time frame: At the end of each cycle (each cycle average is 28 days)
Duration of Hospital Admission in Patients That Developed Infection and Febrile Neutropenia at the End of Each Treatment Cycle
Time frame: At the end of each cycle (each cycle average is 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32683126Sabnis HS, Minson KA, Monroe C, Allen K, Metts JL, Cooper TM, Woods WG, Castellino SM, Keller FG. A strategy to reduce cumulative anthracycline exposure in low-risk pediatric acute myeloid leukemia while maintaining favorable outcomes. Leuk Res. 2020 Sep;96:106421. doi: 10.1016/j.leukres.2020.106421. Epub 2020 Jul 12.
- Individual participant dataSharing planned: No
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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.
Himalee Sabnis, MD principal investigator
Emory University
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 Cytarabine, Daunorubicin and Erwinase in people with Acute Myeloid Leukemia and AML, Childhood, run by Emory University 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 9 inclusion and 13 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 15 Jun 2022. 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 15 Jun 2022). 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?
Event-free Survival (EFS) in Low Risk Patients and High Risk Patients (time frame: Up to 2 years post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326439, which also lists 1 linked publication.
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 15 Jun 2022.