Acute Lymphoblastic Leukemia ALLNCT07113132
Role of SF3B1 Mutation in Assessment of Acute and Chronic Lymphatic Leukemia
An observational study of Acute Lymphoblastic Leukemia ALL and Chronic Lymphocytic Leukemia (CLL), run by Safaa Ali.
Trial summary
aim of the work 1. To evaluate the presence of SF3B1-K700E mutation in acute lymphoblastic leukemia and chronic lymphocytic leukemia. 2. To determine the correlation between the presence of SF3B1-K700E mutation with other laboratory findings. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia ALL, Chronic Lymphocytic Leukemia (CLL)
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Jul 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study will be conducted on peripheral blood samples of 28 acute lymphoblastic leukemia patients, 28 chronic lymphocytic leukemia patients and 28 control.
Who may be able to join
- Patients with acute lymphocytic leukemia or chronic lymphocytic leukemia of both genders at any age.
Who cannot join
- Patients with any other type of malignancies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
aim of the work
- To evaluate the presence of SF3B1-K700E mutation in acute lymphoblastic leukemia and chronic lymphocytic leukemia.
- To determine the correlation between the presence of SF3B1-K700E mutation with other laboratory findings.
Read the detailed description
Leukemia is one of the deadliest diseases having negative impact on people all over the world. Acute Lymphocytic Leukemia (ALL) is a type of WBC cancer, it's a rapidly invasive disease that originates from B- or T-lymphocyte progenitors. Accumulation of lymphoblasts and suppression of normal cells are the main characteristics of the disease course .
Acute lymphoblastic leukemia (ALL) predominantly affects children, with an incidence of 3-4/100,000 in patients under 14 years of age. The five-year survival rate is approximately 90% in children and 65% in adults .
The French-American-British (FAB) categorizes ALL into three subtypes However, the WHO classification incorporates immunophenotypic and genetic details, offering a more accurate and clinically significant classification, helping to choose therapies and prognostic evaluations according to the distinct characteristics of leukemia. Medical professionals have recently recommended that WHO categorization is better compared to FAB .
Chronic lymphoproliferative diseases (CLPD) are considered as a heterogeneous group of diseases characterized by monoclonal expansion and accumulation of apparently mature lymphocytes, which have a proliferative and/or survival advantage over normal lymphocytes in different organs such as bone marrow, peripheral blood and lymph nodes. This translates into the progressive accumulation of clonal cells and their products, causing peripheral blood and bone marrow lymphocytosis, in addition to lymphadenopathy, splenomegaly or other organomegaly .
Recently, mutations in the genes involved in the spliceosome have attracted considerable interest in different neoplasms. Among the spliceosome mutations, those in the SF3B1 gene are the most frequent and relevant in haematological diseases. Most human genes encode several mRNA isoforms by the alternative splicing process. Because alternatively spliced mRNA isoforms are often associated with cancer, spliceosome mutations have recently sparked significant interest in different neoplasms .
splicing of RNA is a fundamental process in eukaryotes, The spliceosome dynamically assembles on messenger RNA precursors (pre-mRNA), removing introns (regions that do not encode proteins) from pre-mRNA, leaving exons (the remainder of RNA transcription) attached .
It is known that SF3B1 mutations could play multiple roles in the pathogenesis of tumours by dysregulating several cellular functions and pathways, including heme biosynthesis, mitochondrial metabolism, and the NF-κB pathway .
The messenger RNA (mRNA) spliceosome is composed of a complex of five small nuclear ribonucleoproteins (snRNP) U1, U2, U4, U5, and U6 and other proteins and plays critical roles in regulating mRNA splicing and subsequent protein expression. It is assembled through binding of U1 snRNP to the 5' splice site of the pre-mRNA, recruitment of U2snRNP to the 3' splicing site at the intron-exon junction guided by the branch region sequence, and joining of the tri-snRNP U4/U5/U6 .
SF3B1, an essential protein in the U2snRNP complex, facilitates U2snRNP binding at the branch point near the 3' splicing site. SF3B1 mutants were shown to alter U2snRNP function by promoting alternative branch-point usage and induction of cryptic 3' splice site selection, thereby generating aberrantly spliced mRNA transcripts subject to nonsense-mediated decay and downregulation of target transcripts and protein expression .
The SF3B1 gene is located on the long arm of chromosome 2 (2q33.1) and encodes for the biggest subunit (155 KDa) of the splicing factor 3b protein complex . The interaction between the SF3B1 complex, the 12S unit, and the splicing factor 3a complex gives rise to the U2 small nuclear ribonucleoproteins (snRNP), fundamental for spliceosome assembly and mRNA splicing . The SF3B1 protein is located principally in the nucleus, where it forms nuclear speckles; it is necessary to anchor U2 snRNP to the pre-mRNA by sequence-independently binding the intron branch site .
SF3B1 high proportion in hematopoietic malignancies occurs within codon 700 (K700E) located in the HEAT domain repeat sequence. In addition, hotspots such as R625, K666, and H662 also occur in some proportion , which are thought to have similar mutational functions due to their spatial proximity to K700E in HEAT repeats. .
The most common SF3B1 mutation is an A to G transition that results in lysine to glutamic acid substitution at amino acid position 700 (SF3B1-K700E) .
Mutated SF3B1 gives rise to a protein with a neomorphic activity linked to several mechanisms involved in RNA processing. About half of aberrantly spliced mRNAs are characterized by the presence of premature stop codons, resulting in nonsense-mediated RNA decay and downregulation of the protein expression. Although the wild-type allele is still able to be expressed, the amount of protein produced is unable to compensate for the mutant allele. Another possibility is the translation of new proteins that lack the correct biological function and/or that acquire aberrant functions .
A study has shown Hotspot K700E and non-K700E SF3B1mut MDS show distinct clinical and mutational profiles in MDS, with K700E showing significantly better Overall survival than non-K700E and SF3B1wt. Only the absence of the SF3B1mut K700E mutation independently predicted worse Overall survival in MDS. Hence, identification of the SF3B1 mutation type is important for risk stratification .
In the study by Wang and colleges, somatic mutations of SF3B1 were found in approximately 15% of patients, making this the second most frequently mutated gene in CLL .
In a cohort of 537 unselected CLL cases, SF3B1 mutations were present in (8.9%) of cases , The residues surrounding Lys700 were the most frequently mutated (48%) .
Quesada and colleges in 2012 studied 279 untreated patients with CLL and found SF3B1 mutations in 27 (10%) . the most frequent mutation was K700E, occurring in almost half of the cases, No SF3B1 mutation was detected in 156 patients with non-Hodgkin lymphoma . CLL patients with mutations in SF3B1 had more aggressive disease and shorter overall survival than patients without these mutations .
Another study provided evidence that the SF3B1 inhibitor H3B-8800 displays therapeutic effects in mouse models of CLL, particularly when used on CLL cells harbouring SF3B1 mutations .
To address the functional role of SF3B1 in T-ALL, SF3B1 was silenced in T-ALL cell lines using short hairpin RNAs (shRNAs). The cell proliferation rate was significantly decreased upon SF3B1 silencing, accompanied by an increase in apoptotic cell death and G2-M cell cycle arrest. To further assess the role of SF3B1 in disease progression in vivo, SF3B1 was silenced in luciferase-expressing CUTLL1 cells and transplanted the cells into immunocompromised mice. SF3B1 silencing led to a significantly reduced tumour burden and prolonged mouse survival .
- Keywords
- sf3b1 mutation, all, cll
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all patients group | peripheral blood samples of 28 acute lymphoblastic leukemia patients | |
| cll patients | peripheral blood samples of 28 chronic lymphocytic leukemia patients | |
| control group | peripheral blood samples of 28 control |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- To evaluate the presence of SF3B1-K700E mutation in acute lymphoblastic leukemia and chronic lymphocytic leukemia using PCR technique
ARMS PCR technique will be used to detect the presence of SF3B1-MUTATION in acute lymphoblastic leukemia and chronic lymphocytic leukemia
Measured: 2 years
2-To determine the effect of presence of SF3B1-K700E mutation with other laboratory findings.
determine if the presence of SF3B1-mutation can affect the clinical data as severity of disease or organomegaly and laboratory data as count of white blood cells and platalet and hemoglobin level using automated cbc analyser and bone marrow of the patients (cellularity and count of blast cells) and result of flow cytometry
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (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 Leukemia ALLStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Safaa Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Safaa Ali, Assiut University
- Investigators
- Sohair m Farghaly, professor, Study director, Assiut UniversityTaghred m Kamal El-Din, asst. prof, Study chair, Assiut UniversityHebatallah Abdellatif, asst. prof, Study chair, Assiut Universitysafaa a omran, asst. lect., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113132
- Sponsor's protocol ID
- sf3b1 mutation in ALL and CLL
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cilloni D, Itri F, Bonuomo V, Petiti J. SF3B1 Mutations in Hematological Malignancies. Cancers (Basel). 2022 Oct 8;14(19):4927. doi: 10.3390/cancers14194927.
PubMed 36230848Wang L, Lawrence MS, Wan Y, Stojanov P, Sougnez C, Stevenson K, Werner L, Sivachenko A, DeLuca DS, Zhang L, Zhang W, Vartanov AR, Fernandes SM, Goldstein NR, Folco EG, Cibulskis K, Tesar B, Sievers QL, Shefler E, Gabriel S, Hacohen N, Reed R, Meyerson M, Golub TR, Lander ES, Neuberg D, Brown JR, Getz G, Wu CJ. SF3B1 and other novel cancer genes in chronic lymphocytic leukemia. N Engl J Med. 2011 Dec 29;365(26):2497-506. doi: 10.1056/NEJMoa1109016. Epub 2011 Dec 12.
PubMed 22150006Han C, Khodadadi-Jamayran A, Lorch AH, Jin Q, Serafin V, Zhu P, Politanska Y, Sun L, Gutierrez-Diaz BT, Pryzhkova MV, Abdala-Valencia H, Bartom ET, Buldini B, Basso G, Velu SE, Sarma K, Mattamana BB, Cho BK, Obeng RC, Goo YA, Jordan PW, Tsirigos A, Zhou Y, Ntziachristos P. SF3B1 homeostasis is critical for survival and therapeutic response in T cell leukemia. Sci Adv. 2022 Jan 21;8(3):eabj8357. doi: 10.1126/sciadv.abj8357. Epub 2022 Jan 21.
PubMed 35061527
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of SF3B1 Mutation in Assessment of Acute and Chronic Lymphatic Leukemia
- ClinicalTrials.gov ID
- NCT07113132
- Acronym / sponsor ID
- sf3b1 mutation in ALL and CLL
- Keywords
- sf3b1 mutation, all, cll
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Safaa AliUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Aug 2025 (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.
aim of the work
- To evaluate the presence of SF3B1-K700E mutation in acute lymphoblastic leukemia and chronic lymphocytic leukemia.
- To determine the correlation between the presence of SF3B1-K700E mutation with other laboratory findings.
Detailed description
Leukemia is one of the deadliest diseases having negative impact on people all over the world. Acute Lymphocytic Leukemia (ALL) is a type of WBC cancer, it's a rapidly invasive disease that originates from B- or T-lymphocyte progenitors. Accumulation of lymphoblasts and suppression of normal cells are the main characteristics of the disease course .
Acute lymphoblastic leukemia (ALL) predominantly affects children, with an incidence of 3-4/100,000 in patients under 14 years of age. The five-year survival rate is approximately 90% in children and 65% in adults .
The French-American-British (FAB) categorizes ALL into three subtypes However, the WHO classification incorporates immunophenotypic and genetic details, offering a more accurate and clinically significant classification, helping to choose therapies and prognostic evaluations according to the distinct characteristics of leukemia. Medical professionals have recently recommended that WHO categorization is better compared to FAB .
Chronic lymphoproliferative diseases (CLPD) are considered as a heterogeneous group of diseases characterized by monoclonal expansion and accumulation of apparently mature lymphocytes, which have a proliferative and/or survival advantage over normal lymphocytes in different organs such as bone marrow, peripheral blood and lymph nodes. This translates into the progressive accumulation of clonal cells and their products, causing peripheral blood and bone marrow lymphocytosis, in addition to lymphadenopathy, splenomegaly or other organomegaly .
Recently, mutations in the genes involved in the spliceosome have attracted considerable interest in different neoplasms. Among the spliceosome mutations, those in the SF3B1 gene are the most frequent and relevant in haematological diseases. Most human genes encode several mRNA isoforms by the alternative splicing process. Because alternatively spliced mRNA isoforms are often associated with cancer, spliceosome mutations have recently sparked significant interest in different neoplasms .
splicing of RNA is a fundamental process in eukaryotes, The spliceosome dynamically assembles on messenger RNA precursors (pre-mRNA), removing introns (regions that do not encode proteins) from pre-mRNA, leaving exons (the remainder of RNA transcription) attached .
It is known that SF3B1 mutations could play multiple roles in the pathogenesis of tumours by dysregulating several cellular functions and pathways, including heme biosynthesis, mitochondrial metabolism, and the NF-κB pathway .
The messenger RNA (mRNA) spliceosome is composed of a complex of five small nuclear ribonucleoproteins (snRNP) U1, U2, U4, U5, and U6 and other proteins and plays critical roles in regulating mRNA splicing and subsequent protein expression. It is assembled through binding of U1 snRNP to the 5' splice site of the pre-mRNA, recruitment of U2snRNP to the 3' splicing site at the intron-exon junction guided by the branch region sequence, and joining of the tri-snRNP U4/U5/U6 .
SF3B1, an essential protein in the U2snRNP complex, facilitates U2snRNP binding at the branch point near the 3' splicing site. SF3B1 mutants were shown to alter U2snRNP function by promoting alternative branch-point usage and induction of cryptic 3' splice site selection, thereby generating aberrantly spliced mRNA transcripts subject to nonsense-mediated decay and downregulation of target transcripts and protein expression .
The SF3B1 gene is located on the long arm of chromosome 2 (2q33.1) and encodes for the biggest subunit (155 KDa) of the splicing factor 3b protein complex . The interaction between the SF3B1 complex, the 12S unit, and the splicing factor 3a complex gives rise to the U2 small nuclear ribonucleoproteins (snRNP), fundamental for spliceosome assembly and mRNA splicing . The SF3B1 protein is located principally in the nucleus, where it forms nuclear speckles; it is necessary to anchor U2 snRNP to the pre-mRNA by sequence-independently binding the intron branch site .
SF3B1 high proportion in hematopoietic malignancies occurs within codon 700 (K700E) located in the HEAT domain repeat sequence. In addition, hotspots such as R625, K666, and H662 also occur in some proportion , which are thought to have similar mutational functions due to their spatial proximity to K700E in HEAT repeats. .
The most common SF3B1 mutation is an A to G transition that results in lysine to glutamic acid substitution at amino acid position 700 (SF3B1-K700E) .
Mutated SF3B1 gives rise to a protein with a neomorphic activity linked to several mechanisms involved in RNA processing. About half of aberrantly spliced mRNAs are characterized by the presence of premature stop codons, resulting in nonsense-mediated RNA decay and downregulation of the protein expression. Although the wild-type allele is still able to be expressed, the amount of protein produced is unable to compensate for the mutant allele. Another possibility is the translation of new proteins that lack the correct biological function and/or that acquire aberrant functions .
A study has shown Hotspot K700E and non-K700E SF3B1mut MDS show distinct clinical and mutational profiles in MDS, with K700E showing significantly better Overall survival than non-K700E and SF3B1wt. Only the absence of the SF3B1mut K700E mutation independently predicted worse Overall survival in MDS. Hence, identification of the SF3B1 mutation type is important for risk stratification .
In the study by Wang and colleges, somatic mutations of SF3B1 were found in approximately 15% of patients, making this the second most frequently mutated gene in CLL .
In a cohort of 537 unselected CLL cases, SF3B1 mutations were present in (8.9%) of cases , The residues surrounding Lys700 were the most frequently mutated (48%) .
Quesada and colleges in 2012 studied 279 untreated patients with CLL and found SF3B1 mutations in 27 (10%) . the most frequent mutation was K700E, occurring in almost half of the cases, No SF3B1 mutation was detected in 156 patients with non-Hodgkin lymphoma . CLL patients with mutations in SF3B1 had more aggressive disease and shorter overall survival than patients without these mutations .
Another study provided evidence that the SF3B1 inhibitor H3B-8800 displays therapeutic effects in mouse models of CLL, particularly when used on CLL cells harbouring SF3B1 mutations .
To address the functional role of SF3B1 in T-ALL, SF3B1 was silenced in T-ALL cell lines using short hairpin RNAs (shRNAs). The cell proliferation rate was significantly decreased upon SF3B1 silencing, accompanied by an increase in apoptotic cell death and G2-M cell cycle arrest. To further assess the role of SF3B1 in disease progression in vivo, SF3B1 was silenced in luciferase-expressing CUTLL1 cells and transplanted the cells into immunocompromised mice. SF3B1 silencing led to a significantly reduced tumour burden and prolonged mouse survival .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| all patients group | – | –peripheral blood samples of 28 acute lymphoblastic leukemia patients |
| cll patients | – | –peripheral blood samples of 28 chronic lymphocytic leukemia patients |
| control group | – | –peripheral blood samples of 28 control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study will be conducted on peripheral blood samples of 28 acute lymphoblastic leukemia patients, 28 chronic lymphocytic leukemia patients and 28 control.
Key inclusion criteria (1 listed)
- Patients with acute lymphocytic leukemia or chronic lymphocytic leukemia of both genders at any age.
Key exclusion criteria (1 listed)
- Patients with any other type of malignancies
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
1- To evaluate the presence of SF3B1-K700E mutation in acute lymphoblastic leukemia and chronic lymphocytic leukemia using PCR technique
Time frame: 2 years
ARMS PCR technique will be used to detect the presence of SF3B1-MUTATION in acute lymphoblastic leukemia and chronic lymphocytic leukemia
2-To determine the effect of presence of SF3B1-K700E mutation with other laboratory findings.
Time frame: two years
determine if the presence of SF3B1-mutation can affect the clinical data as severity of disease or organomegaly and laboratory data as count of white blood cells and platalet and hemoglobin level using automated cbc analyser and bone marrow of the patients (cellularity and count of blast cells) and result of flow cytometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 36230848Cilloni D, Itri F, Bonuomo V, Petiti J. SF3B1 Mutations in Hematological Malignancies. Cancers (Basel). 2022 Oct 8;14(19):4927. doi: 10.3390/cancers14194927.
- Background: PubMed 22150006Wang L, Lawrence MS, Wan Y, Stojanov P, Sougnez C, Stevenson K, Werner L, Sivachenko A, DeLuca DS, Zhang L, Zhang W, Vartanov AR, Fernandes SM, Goldstein NR, Folco EG, Cibulskis K, Tesar B, Sievers QL, Shefler E, Gabriel S, Hacohen N, Reed R, Meyerson M, Golub TR, Lander ES, Neuberg D, Brown JR, Getz G, Wu CJ. SF3B1 and other novel cancer genes in chronic lymphocytic leukemia. N Engl J Med. 2011 Dec 29;365(26):2497-506. doi: 10.1056/NEJMoa1109016. Epub 2011 Dec 12.
- Background: PubMed 35061527Han C, Khodadadi-Jamayran A, Lorch AH, Jin Q, Serafin V, Zhu P, Politanska Y, Sun L, Gutierrez-Diaz BT, Pryzhkova MV, Abdala-Valencia H, Bartom ET, Buldini B, Basso G, Velu SE, Sarma K, Mattamana BB, Cho BK, Obeng RC, Goo YA, Jordan PW, Tsirigos A, Zhou Y, Ntziachristos P. SF3B1 homeostasis is critical for survival and therapeutic response in T cell leukemia. Sci Adv. 2022 Jan 21;8(3):eabj8357. doi: 10.1126/sciadv.abj8357. Epub 2022 Jan 21.
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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.
Sohair m Farghaly, professor study director
Assiut University
Taghred m Kamal El-Din, asst. prof study chair
Assiut University
Hebatallah Abdellatif, asst. prof study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia ALL and Chronic Lymphocytic Leukemia (CLL), run by Safaa Ali.
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 1 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: opening soon, as of the sponsor's last update on 8 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact safaa a omran, asst. lect. (+201060284142, safaaali1491994@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- To evaluate the presence of SF3B1-K700E mutation in acute lymphoblastic leukemia and chronic lymphocytic leukemia using PCR technique (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT07113132, 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 8 Aug 2025.