Chronic LeukemiaNCT07445984
Chemogenomic Profiling in Hematological Malignancies (HEM-Profiling 2021)
A study testing Genetic, molecular and/or omics analyses in people with Chronic Leukemia and Acute Leukemia, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial summary
The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders
- What is being tested?
- Genetic, molecular and/or omics analyses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jul 2021to 28 Jul 2026
- Phase
- Interventional
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient aged >1 year old, referred for evaluation to the University Hospital of Parma;
- Retrospective study: previously patients with hematological malignancies;
- Prospective study: 1) patients with clinical suspect of hematological malignancies which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc. 2) patients with clinical suspect of relapsed/refractory onco-hematological disorder, which requires a diagnostic assessment using bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. 3) patients that progress in blastic transformation from a chronic condition or suspect of relapsed/refractory hematological disease, which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc;
- Written informed consent. Retrospective study: informed consent will be signed during the first follow-up visit.
Who cannot join
- Age <1 year old
- Patients who are unable to provide informed consent prior to any procedure for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Parma
Parma, PR, 43126
Giovanni Roti, Medical doctor, PhD, giovanni.roti@unipr.it
About this study
The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic evaluation for a suspect or a defined diagnosis of hematological malignancies collected at the University Hospital of Parma.
Read the detailed description
The hematological malignancies are referred to all the different hematological entities according to WHO 2016 Classification such as acute (AML, ALL) or chronic leukemia (CLL, CML, HCL), myeloproliferative or lymphoproliferative disorders (MF, PV, TE, CMML, NHL, HL) and myelodysplastic or myelodysplastic/myeloproliferative disorders.
- Conditions
- Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders, Lymphoproliferative Disorders, Myelodysplastic Disorders
- Being tested
- Genetic, molecular and/or omics analyses
- Medical subject headings
- Myeloproliferative Disorders, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic, molecular and/or omics analysesOther
The focus of our scientific approach is based on genetic, molecular and/or omics analyses performed with new technologies (Nanostring, NGS, single cell technologies, radiomics)
| Study group | Role | What they receive |
|---|---|---|
| Hematological malignancies | Other | Patients with hematological malignancies either treatment free or relapsed/ refractory Receives: Other: Genetic, molecular and/or omics analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the anti-cancer activity of bio-active compounds and derivatives present in FDA/EMA approved or investigator provided libraries, investigational molecules
The study will be performed in malignant cells of a cohort of 250 patients with onco-hematological disorders obtained from a bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. separated by a tissue-specific protocol: densitometry protocol for peripheral or bone marrow blood, tissue fractionation for tissue biopsies, precipitation for liquor. Cells will be than cultured in the presence or absence of small molecules derived from chemical library FDA/EMA approved, investigational molecules (monoclonal antibodies, antibody-drug conjugate, other experimental compounds). We will use miniaturized assays such cell culture in 384 multiwell plates to maximize the use of primary cells and to test simultaneously multiple concentrations of multiple drugs. We will perform several assays to assess cellular response to drug's perturbation such as: proliferation, cell cycle and apoptosis analysis
Measured: At baseline
To characterize molecular biomarkers for the identification of novel target therapies
Thanks to genetic and molecular and/or omics analyses performed with new technologies (Nanostring, NGS, single cell technologies, radiomics), we propose to study novel molecular target that may be sensitive to the tested compounds in order to identify new target therapies.
Measured: At baseline
Correlate anti-cancer response with diagnostic (WHO classification) and molecular or novel omics features including cytogenetics, genomics, next generation or single cell technologies, radiomics.
The completion of experiments described in aim 1 will give us the opportunity, for example, to extrapolate the IC50 (half maximal inhibitory concentration: a measure of the effectiveness of a substance in inhibiting a specific biological or biochemical function) dose for a small molecule of interest and correlate this value with clinical, cytogenetic, genomic and molecular features of that particular case. These data will be further compared with larger repository publicly available in the literature.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start28 Jul 2021
- Primary completion28 Jul 2026 (estimated)
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic LeukemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Roti, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445984
- Sponsor's protocol ID
- 114/2021/TESS/UNIPR
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemogenomic Profiling in Hematological Malignancies (HEM-Profiling 2021)
- ClinicalTrials.gov ID
- NCT07445984
- Acronym / sponsor ID
- 114/2021/TESS/UNIPR
- Conditions
- Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders, Lymphoproliferative Disorders, Myelodysplastic Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic evaluation for a suspect or a defined diagnosis of hematological malignancies collected at the University Hospital of Parma.
Detailed description
The hematological malignancies are referred to all the different hematological entities according to WHO 2016 Classification such as acute (AML, ALL) or chronic leukemia (CLL, CML, HCL), myeloproliferative or lymphoproliferative disorders (MF, PV, TE, CMML, NHL, HL) and myelodysplastic or myelodysplastic/myeloproliferative disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematological malignancies | Other | Other: Genetic, molecular and/or omics analysesPatients with hematological malignancies either treatment free or relapsed/ refractory |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged >1 year old, referred for evaluation to the University Hospital of Parma;
- Retrospective study: previously patients with hematological malignancies;
- Prospective study: 1) patients with clinical suspect of hematological malignancies which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc. 2) patients with clinical suspect of relapsed/refractory onco-hematological disorder, which requires a diagnostic assessment using bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. 3) patients that progress in blastic transformation from a chronic condition or suspect of relapsed/refractory hematological disease, which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc;
- Written informed consent. Retrospective study: informed consent will be signed during the first follow-up visit.
Key exclusion criteria (2 listed)
- Age <1 year old
- Patients who are unable to provide informed consent prior to any procedure for any reason.
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 |
|---|---|---|
| Genetic, molecular and/or omics analysesThe focus of our scientific approach is based on genetic, molecular and/or omics analyses performed with new technologies (Nanostring, NGS, single cell technologies, radiomics) | Other | Hematological malignancies |
Primary outcome
To evaluate the anti-cancer activity of bio-active compounds and derivatives present in FDA/EMA approved or investigator provided libraries, investigational molecules
Time frame: At baseline
The study will be performed in malignant cells of a cohort of 250 patients with onco-hematological disorders obtained from a bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. separated by a tissue-specific protocol: densitometry protocol for peripheral or bone marrow blood, tissue fractionation for tissue biopsies, precipitation for liquor. Cells will be than cultured in the presence or absence of small molecules derived from chemical library FDA/EMA approved, investigational molecules (monoclonal antibodies, antibody-drug conjugate, other experimental compounds). We will use miniaturized assays such cell culture in 384 multiwell plates to maximize the use of primary cells and to test simultaneously multiple concentrations of multiple drugs. We will perform several assays to assess cellular response to drug's perturbation such as: proliferation, cell cycle and apoptosis analysis
To characterize molecular biomarkers for the identification of novel target therapies
Time frame: At baseline
Thanks to genetic and molecular and/or omics analyses performed with new technologies (Nanostring, NGS, single cell technologies, radiomics), we propose to study novel molecular target that may be sensitive to the tested compounds in order to identify new target therapies.
Correlate anti-cancer response with diagnostic (WHO classification) and molecular or novel omics features including cytogenetics, genomics, next generation or single cell technologies, radiomics.
Time frame: At baseline
The completion of experiments described in aim 1 will give us the opportunity, for example, to extrapolate the IC50 (half maximal inhibitory concentration: a measure of the effectiveness of a substance in inhibiting a specific biological or biochemical function) dose for a small molecule of interest and correlate this value with clinical, cytogenetic, genomic and molecular features of that particular case. These data will be further compared with larger repository publicly available in the literature.
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 3 Mar 2026.
Related trials for Chronic Leukemia
RecruitingPhase 1/2
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic, molecular and/or omics analyses in people with Chronic Leukemia and Acute Leukemia, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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 Italy. 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?
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 Giovanni Roti, Associate Professor (+39 0521 702200, giovanni.roti@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the anti-cancer activity of bio-active compounds and derivatives present in FDA/EMA approved or investigator provided libraries, investigational molecules (time frame: At baseline). The study lists 3 primary outcomes in all. 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 3 Mar 2026.