Benefit: To Patient Have Investigation for Diagnosis and Follow up for His Disease and Reach to New Method Help in Early Diagnosis of Lymphoid DisorderNCT05643547
Immunophenotypic Evaluation of IL-7R α in Acute Leukaemia
An observational study of Benefit: To Patient Have Investigation for Diagnosis and Follow up for His Disease and Reach to New Method Help in Early Diagnosis of Lymphoid Disorder, run by Rania Abdeltwab Abdelazeim.
Trial summary
Acute leukemia is generally understood to be a neoplastic process that exerts a maturational block at a hematopoietic precursor cell level, accompanied by a proliferative drive of varying degree. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benefit: To Patient Have Investigation for Diagnosis and Follow up for His Disease and Reach to New Method Help in Early Diagnosis of Lymphoid Disorder
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 30 Oct 2024
- 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
- Child, Adult, Older adult
Study population: - Newly diagnosed patients with Acute leukemia (ALL, AML), male or female at any age will be investigated for Immunophenotypic expression of IL7R α and its diagnostic value.
Who may be able to join
- Newly diagnosed patients with Acute leukemia (ALL, AML), male or female at any age.
Who cannot join
- Patients diagnosed with hematological malignancy other than acute leukemias
- Patients receiving chemo and/or radiotherapy
- Patients on steroid therapy for any other reason
- Patients receiving any immunosuppressive drug
About this study
Acute leukemia is generally understood to be a neoplastic process that exerts a maturational block at a hematopoietic precursor cell level, accompanied by a proliferative drive of varying degree. The resulting accumulation of cells, most frequently in the marrow, causes the typical clinical picture, which includes marrow failure, tissue infiltration, organomegaly and on occasion, tumor masses. AL is broadly classified as acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) (1).
Acute lymphoblastic leukemia is frequently diagnosed in children and young adults, with incidence peaks between 2 and 5 years of age (2), whereas AML is the most common acute type in adults (3).
Read more
In addition to leukemia cells themselves, cells of the immune system are a fundamental component of the tumor microenvironment (TME), which often modify the TME to be more favorable to tumor development and progression through producing cytokines and mediators (4,5) . Interleukins / interleukin receptors interaction plays important roles in the antitumor immune response through mediating cell-cell communication in TME and is reported to be relevant to patient prognosis (6,7). As a member of the Interleukin family, Interleukin 7 (IL7) play vital roles in hematopoiesis and the development of T lymphocytes, as well as the inflammation, autoimmune diseases and hematological cancers. Its function is mediated by the IL7 R, which is a membrane receptor consisted of the specific IL7Ra chain (CD127) and IL-7Rγ chain (common gamma chain shared by the receptors for IL-2,-4,-9,-15, and-21) (8). It is thus not surprising that activation of IL-7 signalling is seen in the majority of T-ALLs and in some of the B cell precursor ALL (9,10).
Consistent with the absolute requirement of IL-7 to human T cell development, most T-ALLs have been shown to respond to IL-7. Thus targeting IL-7 signaling might be a reasonable general approach for treatment of T-ALL, regardless the presence of activating mutations. (10)
Read the detailed description
Acute leukemia is generally understood to be a neoplastic process that exerts a maturational block at a hematopoietic precursor cell level, accompanied by a proliferative drive of varying degree. The resulting accumulation of cells, most frequently in the marrow, causes the typical clinical picture, which includes marrow failure, tissue infiltration, organomegaly and on occasion, tumor masses. AL is broadly classified as acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) (1).
Acute lymphoblastic leukemia is frequently diagnosed in children and young adults, with incidence peaks between 2 and 5 years of age (2), whereas AML is the most common acute type in adults (3).
In addition to leukemia cells themselves, cells of the immune system are a fundamental component of the tumor microenvironment (TME), which often modify the TME to be more favorable to tumor development and progression through producing cytokines and mediators (4,5) . Interleukins / interleukin receptors interaction plays important roles in the antitumor immune response through mediating cell-cell communication in TME and is reported to be relevant to patient prognosis (6,7). As a member of the Interleukin family, Interleukin 7 (IL7) play vital roles in hematopoiesis and the development of T lymphocytes, as well as the inflammation, autoimmune diseases and hematological cancers. Its function is mediated by the IL7 R, which is a membrane receptor consisted of the specific IL7Ra chain (CD127) and IL-7Rγ chain (common gamma chain shared by the receptors for IL-2,-4,-9,-15, and-21) (8). It is thus not surprising that activation of IL-7 signalling is seen in the majority of T-ALLs and in some of the B cell precursor ALL (9,10).
Consistent with the absolute requirement of IL-7 to human T cell development, most T-ALLs have been shown to respond to IL-7. Thus targeting IL-7 signaling might be a reasonable general approach for treatment of T-ALL, regardless the presence of activating mutations. (10).
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunophenotypic expression of IL7R α in acute leukemia cases.
Immunophenotypic expression of IL7R α in acute leukemia cases.
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Mar 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benefit: To Patient Have Investigation for Diagnosis and Follow up for His Disease and Reach to New Method Help in Early Diagnosis of Lymphoid DisorderStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rania Abdeltwab Abdelazeim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Abdeltwab Abdelazeim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643547
- Sponsor's protocol ID
- 159159
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotypic Evaluation of IL-7R α in Acute Leukaemia
- ClinicalTrials.gov ID
- NCT05643547
- Acronym / sponsor ID
- 159159
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Rania Abdeltwab AbdelazeimUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 8 Dec 2022 (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 leukemia is generally understood to be a neoplastic process that exerts a maturational block at a hematopoietic precursor cell level, accompanied by a proliferative drive of varying degree. The resulting accumulation of cells, most frequently in the marrow, causes the typical clinical picture, which includes marrow failure, tissue infiltration, organomegaly and on occasion, tumor masses. AL is broadly classified as acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) (1).
Acute lymphoblastic leukemia is frequently diagnosed in children and young adults, with incidence peaks between 2 and 5 years of age (2), whereas AML is the most common acute type in adults (3).
In addition to leukemia cells themselves, cells of the immune system are a fundamental component of the tumor microenvironment (TME), which often modify the TME to be more favorable to tumor development and progression through producing cytokines and mediators (4,5) . Interleukins / interleukin receptors interaction plays important roles in the antitumor immune response through mediating cell-cell communication in TME and is reported to be relevant to patient prognosis (6,7). As a member of the Interleukin family, Interleukin 7 (IL7) play vital roles in hematopoiesis and the development of T lymphocytes, as well as the inflammation, autoimmune diseases and hematological cancers. Its function is mediated by the IL7 R, which is a membrane receptor consisted of the specific IL7Ra chain (CD127) and IL-7Rγ chain (common gamma chain shared by the receptors for IL-2,-4,-9,-15, and-21) (8). It is thus not surprising that activation of IL-7 signalling is seen in the majority of T-ALLs and in some of the B cell precursor ALL (9,10).
Consistent with the absolute requirement of IL-7 to human T cell development, most T-ALLs have been shown to respond to IL-7. Thus targeting IL-7 signaling might be a reasonable general approach for treatment of T-ALL, regardless the presence of activating mutations. (10)
Detailed description
Acute leukemia is generally understood to be a neoplastic process that exerts a maturational block at a hematopoietic precursor cell level, accompanied by a proliferative drive of varying degree. The resulting accumulation of cells, most frequently in the marrow, causes the typical clinical picture, which includes marrow failure, tissue infiltration, organomegaly and on occasion, tumor masses. AL is broadly classified as acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) (1).
Acute lymphoblastic leukemia is frequently diagnosed in children and young adults, with incidence peaks between 2 and 5 years of age (2), whereas AML is the most common acute type in adults (3).
In addition to leukemia cells themselves, cells of the immune system are a fundamental component of the tumor microenvironment (TME), which often modify the TME to be more favorable to tumor development and progression through producing cytokines and mediators (4,5) . Interleukins / interleukin receptors interaction plays important roles in the antitumor immune response through mediating cell-cell communication in TME and is reported to be relevant to patient prognosis (6,7). As a member of the Interleukin family, Interleukin 7 (IL7) play vital roles in hematopoiesis and the development of T lymphocytes, as well as the inflammation, autoimmune diseases and hematological cancers. Its function is mediated by the IL7 R, which is a membrane receptor consisted of the specific IL7Ra chain (CD127) and IL-7Rγ chain (common gamma chain shared by the receptors for IL-2,-4,-9,-15, and-21) (8). It is thus not surprising that activation of IL-7 signalling is seen in the majority of T-ALLs and in some of the B cell precursor ALL (9,10).
Consistent with the absolute requirement of IL-7 to human T cell development, most T-ALLs have been shown to respond to IL-7. Thus targeting IL-7 signaling might be a reasonable general approach for treatment of T-ALL, regardless the presence of activating mutations. (10).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- - Newly diagnosed patients with Acute leukemia (ALL, AML), male or female at any age will be investigated for Immunophenotypic expression of IL7R α and its diagnostic value.
Key inclusion criteria (1 listed)
- Newly diagnosed patients with Acute leukemia (ALL, AML), male or female at any age.
Key exclusion criteria (4 listed)
- Patients diagnosed with hematological malignancy other than acute leukemias
- Patients receiving chemo and/or radiotherapy
- Patients on steroid therapy for any other reason
- Patients receiving any immunosuppressive drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunophenotypic expression of IL7R α in acute leukemia cases.
Time frame: 2022-2024
Immunophenotypic expression of IL7R α in acute leukemia cases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Benefit: To Patient Have Investigation for Diagnosis and Follow up for His Disease and Reach to New Method Help in Early Diagnosis of Lymphoid Disorder, run by Rania Abdeltwab Abdelazeim.
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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Immunophenotypic expression of IL7R α in acute leukemia cases. (time frame: 2022-2024). 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 8 Dec 2022.