Acute Lymphoblastic LeukemiaNCT03249636
New Markers for Minimal Residual Disease in Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by Assiut University at 1 site in Egypt.
Trial summary
Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the overproduction and accumulation of cancerous, immature white blood cells, known as lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as red and white blood cells and platelets) in the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Flow cytometric analysis
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2017to Oct 2019
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: New cases of patients with acute lymphocytic leukemia.
Who may be able to join
- 1. New cases of patients with acute lymphocytic leukemia. 2. Evaluation of markers 15 days after induction.
Who cannot join
- Patients died after induction
- Patients diagnosed as Non Hodgkin Lymphoma.
Trial locations and contacts
1 site in 1 country.
Noha G Sayed, Dr. contact
Egypt1 site
Assiut University
Asyut
Maureen R Farag, 01018548568, maureen.farag@yahoo.com
About this study
Official title: Evaluation of New Markers for Minimal Residual Disease in Precursor B Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the overproduction and accumulation of cancerous, immature white blood cells, known as lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating) to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak incidence at 2-5 years of age and another peak in old age.
Read the detailed description
In recent years, new pieces of information obtained through immunophenotyping, cytogenetics and genomic profiling. Chemotherapy resistance have contributed to a better understanding of the pathology of this complex disorder and to recognition of subgroups of patients who respond differently to therapy.
The possible impact of the expression of various markers has been studied in ALL.
In patients with acute leukemia, treatment decisions are based on the status of peripheral blood and bone marrow cellularity. This provides a measure of the efficacy of therapy and can reveal leukemia relapse. The reliability of morphologic examination of peripheral blood and bone marrow largely depends on the hematologist's expertise, and its sensitivity is fundamentally limited by the similarities in appearance between leukemic cells and normal lympho-hematopoietic progenitors. Therefore, patients in complete morphologic remission may still have a large number of residual leukemic cells (potentially up to 1010).
Minimal residual disease (MRD) is currently the most powerful prognostic indicator in Precursor B acute lymphoblastic leukemia (B ALL). MRD analysis can be done by either flow cytometric or molecular techniques. Flow cytometric detection holds potential for wider applicability than molecular techniques because flow cytometric methods for leukemia diagnosis are already established at most cancer centers worldwide.
Flow cytometric detection of MRD is based on the principle that ALL cells express immunophenotypic features that can be used to distinguish them from normal hematopoietic cells, including hematogones and activated lymphocytes commonly referred to as Leukemia associated immunophenotype (LAIP). In virtually all patients with ALL, leukemia-associated immunophenotypes can be defined at diagnosis and then used to monitor MRD during treatment.
The reliability of flow cytometric MRD assays depends on several factors. The most important being the correct marker combination in use. Applicability is limited in some cases by the lack of suitable leukemia associated immunophenotype (LAIP) with the currently used markers and also antigen immunomodulation post treatment. Therefore, the identification of new leukemia markers that are easily detectable and are stably expressed in a large proportion of ALL cases should simplify the application of MRD studies, help extend their benefit to all patients and possibly enhance the sensitivity of MRD detection.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Flow cytometric analysis
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometric analysisDiagnostic test
Level of expression of the markers and the correlation between the markers with each other and with the clinical presentation and impact on patients with ALL.
| Study group | Role | What they receive |
|---|---|---|
| ALL patients | New cases of patients with acute lymphocytic leukemia. Evaluation of markers 15 days after induction. Receives: Diagnostic Test: Flow cytometric analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of expression of markers in acute lymphoblastic leukemia.
Level of expression of CD66c, CD 123 \& CD 73 in acute lymphocytic leukemia ,the correlation with each other .and with the clinical assessment of patients before and after induction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study startDec 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen Farag, Assiut University
- Investigators
- Maureen R Farag, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249636
- Sponsor's protocol ID
- MFARAG
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Campana D, Coustan-Smith E. Measurements of treatment response in childhood acute leukemia. Korean J Hematol. 2012 Dec;47(4):245-54. doi: 10.5045/kjh.2012.47.4.245. Epub 2012 Dec 24.
PubMed 23320002Campana D, Behm FG. Immunophenotyping of leukemia. J Immunol Methods. 2000 Sep 21;243(1-2):59-75. doi: 10.1016/s0022-1759(00)00228-3.
PubMed 10986407Inaba H, Greaves M, Mullighan CG. Acute lymphoblastic leukaemia. Lancet. 2013 Jun 1;381(9881):1943-55. doi: 10.1016/S0140-6736(12)62187-4. Epub 2013 Mar 22.
PubMed 23523389
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Markers for Minimal Residual Disease in Precursor B Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03249636
- Acronym / sponsor ID
- MFARAG
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the overproduction and accumulation of cancerous, immature white blood cells, known as lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating) to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak incidence at 2-5 years of age and another peak in old age.
Detailed description
In recent years, new pieces of information obtained through immunophenotyping, cytogenetics and genomic profiling. Chemotherapy resistance have contributed to a better understanding of the pathology of this complex disorder and to recognition of subgroups of patients who respond differently to therapy.
The possible impact of the expression of various markers has been studied in ALL.
In patients with acute leukemia, treatment decisions are based on the status of peripheral blood and bone marrow cellularity. This provides a measure of the efficacy of therapy and can reveal leukemia relapse. The reliability of morphologic examination of peripheral blood and bone marrow largely depends on the hematologist's expertise, and its sensitivity is fundamentally limited by the similarities in appearance between leukemic cells and normal lympho-hematopoietic progenitors. Therefore, patients in complete morphologic remission may still have a large number of residual leukemic cells (potentially up to 1010).
Minimal residual disease (MRD) is currently the most powerful prognostic indicator in Precursor B acute lymphoblastic leukemia (B ALL). MRD analysis can be done by either flow cytometric or molecular techniques. Flow cytometric detection holds potential for wider applicability than molecular techniques because flow cytometric methods for leukemia diagnosis are already established at most cancer centers worldwide.
Flow cytometric detection of MRD is based on the principle that ALL cells express immunophenotypic features that can be used to distinguish them from normal hematopoietic cells, including hematogones and activated lymphocytes commonly referred to as Leukemia associated immunophenotype (LAIP). In virtually all patients with ALL, leukemia-associated immunophenotypes can be defined at diagnosis and then used to monitor MRD during treatment.
The reliability of flow cytometric MRD assays depends on several factors. The most important being the correct marker combination in use. Applicability is limited in some cases by the lack of suitable leukemia associated immunophenotype (LAIP) with the currently used markers and also antigen immunomodulation post treatment. Therefore, the identification of new leukemia markers that are easily detectable and are stably expressed in a large proportion of ALL cases should simplify the application of MRD studies, help extend their benefit to all patients and possibly enhance the sensitivity of MRD detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL patients | – | Diagnostic Test: Flow cytometric analysisNew cases of patients with acute lymphocytic leukemia. Evaluation of markers 15 days after induction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- New cases of patients with acute lymphocytic leukemia.
Key inclusion criteria (1 listed)
- 1. New cases of patients with acute lymphocytic leukemia. 2. Evaluation of markers 15 days after induction.
Key exclusion criteria (2 listed)
- Patients died after induction
- Patients diagnosed as Non Hodgkin Lymphoma.
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 |
|---|---|---|
| Flow cytometric analysisLevel of expression of the markers and the correlation between the markers with each other and with the clinical presentation and impact on patients with ALL. | Diagnostic test | ALL patients |
Primary outcome
Level of expression of markers in acute lymphoblastic leukemia.
Time frame: 1 year
Level of expression of CD66c, CD 123 \& CD 73 in acute lymphocytic leukemia ,the correlation with each other .and with the clinical assessment of patients before and after induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Background: PubMed 23320002Campana D, Coustan-Smith E. Measurements of treatment response in childhood acute leukemia. Korean J Hematol. 2012 Dec;47(4):245-54. doi: 10.5045/kjh.2012.47.4.245. Epub 2012 Dec 24.
- Background: PubMed 10986407Campana D, Behm FG. Immunophenotyping of leukemia. J Immunol Methods. 2000 Sep 21;243(1-2):59-75. doi: 10.1016/s0022-1759(00)00228-3.
- Background: PubMed 23523389Inaba H, Greaves M, Mullighan CG. Acute lymphoblastic leukaemia. Lancet. 2013 Jun 1;381(9881):1943-55. doi: 10.1016/S0140-6736(12)62187-4. Epub 2013 Mar 22.
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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.
Noha G Sayed, Dr. contact
Maureen R Farag, Resident principal investigator
Assiut University
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 Acute Lymphoblastic Leukemia, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Aug 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania M Bakry, Prof. Dr. (01013341395, rbakry.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of expression of markers in acute lymphoblastic leukemia. (time frame: 1 year). 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 NCT03249636, which also lists 3 linked publications.
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 29 Aug 2017.