T Acute Lymphoblastic LeukemiaNCT04582487
Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL
A study testing bone marrow and/or peripheral blood samples withdrawal in people with T Acute Lymphoblastic Leukemia and Early T Acute Lymphoblastic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 10 sites in Italy.
Trial summary
This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T Acute Lymphoblastic Leukemia, Early T Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma
- What is being tested?
- bone marrow and/or peripheral blood samples withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 10 sitesItaly
- Study dates
- 19 May 2021to May 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients to be enrolled in this study must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in the first relapse or must have failed primary induction chemotherapy (i.e., never attained a complete remission following an initial course of standard therapy for T-ALL/LBL or have a diagnosis of ETP-ALL [T-ALL with the following phenotype: Negative: CD1a-, CD8-, CD4-, CD5 (less than 75% of blasts); CD13+, CD33+, CD34+, CD117+, HLA-DR+, CD11b+, and/or CD65+ -in at least 25% of lymphoblasts
- Ages Eligible for Study: over 18 years
- Patients with T-ALL/LBL must have greater than 5% blasts in the bone marrow with or without extramedullary disease
- Patients with T-ALL/LBL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis
- Patients may have CNS 1 (WBC count in CSF <5 and having no blasts) or CNS 2 (WBC count in CSF <5 and having blasts) disease but not CNS 3 (WBC count in CSF ≥5 and having blasts)
- ECOG 0-2 or Karnofsky ≥ 50%
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- Patients may be enrolled on study regardless of the timing of prior Intrathecal therapy; however, they may not begin treatment on this protocol until a minimum of 7 days has elapsed since prior intrathecal therapy
- Adequate renal function defined as serum creatinine ≤ 1.5x upper limit of normal (ULN) for age. If the serum creatinine is above these values, the calculated creatinine clearance or radioisotope GFR must be ≥ 70 mL/min/1.73m2
- Total bilirubin ≤ 1.5x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ≤ ULN for age
- ALT ≤ 5x ULN of normal for age
- Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or ejection fraction ≥ 45% by gated radionuclide study
- No evidence of dyspnea at rest
- No exercise intolerance
- A pulse oximetry ≥ 94% at sea level (≥ 90% at altitude ≥ 5000 feet) if there is clinical indication for determination
- Patients must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients must sign a written informed consent
Who cannot join
- Significant organ compromise that will increase risk of toxicity or mortality
- Active serious infection not controlled by oral or intravenous antibiotics
- Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
- Known hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
- Active grade III-V cardiac failure as defined by the New York Heart Association Criteria
- Patients with a cardiac ejection fraction (as measured by either multigated acquisition [MUGA] or echocardiogram) < 40%
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Recruiting
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona
Attilio Olivieri, 3289558821, a.olivieri@univpm.it
- Recruiting
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
Bergamo
Alessandro Rambaldi, 3484526901, arambaldi@asst-pg23.it
- Recruiting
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna
Cristina Papayannidis, 3496484441, cristina.papayannidis@unibo.it
- Recruiting
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia
Erika Borlenghi, 3402526539, erika.borlenghi@gmail.com
- Recruiting
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce
Nicola Di Renzo, 3388178577, direnzo.ematolecce@gmail.com
- Recruiting
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre
Renato Bassan, Renato.Bassan@aulss3.veneto.it
- Recruiting
Ematologia ed Immunologia Clinica
Perugia
Cristina Mecucci, cristina.mecucci@unipg.it
Roberta La Starza
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma
Simona Sica, 3355952379, simona.sica@Unicatt.it
- Recruiting
Aou Senese - Uoc Ematologia E Trapianti
Siena
Monica Bocchia, 3495792804, bocchia@unisi.it
- Recruiting
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza
Albana Lico, albana.lico@aulss8.veneto.it
About this study
This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data. As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of identified compound.
Read the detailed description
This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data.
Genomic studies include karyotyping, CI-FISH and sequencing of 72 selected genes recurrently involved in T-ALL (by NGS).
A panel of 80 compounds has been choosen for DSRP profile.
As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of compound hits. Meanwhile, in case of leukocytosis and uncontrolled disease, patients will be treated with cytoreductive therapies and best supportive care according to guidelines and scientific consensus.
Every patient will receive a molecularly and functionally informed therapy following the therapeutic schedule already defined by in other tumors. Treatment will be selected on the basis of integration of genomic and small response data.
- Conditions
- T Acute Lymphoblastic Leukemia, Early T Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma, Etp All
- Being tested
- bone marrow and/or peripheral blood samples withdrawal
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow and/or peripheral blood samples withdrawalOther
bone marrow and/or peripheral blood samples evaluation
| Study group | Role | What they receive |
|---|---|---|
| Biological evaluation | Other | A combined approach of Drug Sensitivity and Resistance Profiling (DSRP) and molecular-cytogenetic findings is used in order to prioritize compounds for tailored therapies. Receives: Other: bone marrow and/or peripheral blood samples withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug sensitivity profile
Frequencies of alternative therapies identified for T-ALL patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start19 May 2021
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Acute Lymphoblastic 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582487
- Sponsor's protocol ID
- ALL2720
- Status last verified
- Feb 2024
- First submitted
- 24 Sep 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL
- ClinicalTrials.gov ID
- NCT04582487
- Acronym / sponsor ID
- ALL2720
- Conditions
- T Acute Lymphoblastic Leukemia, Early T Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma, Etp All
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 9 Oct 2020 (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.
This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data. As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of identified compound.
Detailed description
This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data.
Genomic studies include karyotyping, CI-FISH and sequencing of 72 selected genes recurrently involved in T-ALL (by NGS).
A panel of 80 compounds has been choosen for DSRP profile.
As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of compound hits. Meanwhile, in case of leukocytosis and uncontrolled disease, patients will be treated with cytoreductive therapies and best supportive care according to guidelines and scientific consensus.
Every patient will receive a molecularly and functionally informed therapy following the therapeutic schedule already defined by in other tumors. Treatment will be selected on the basis of integration of genomic and small response data.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological evaluation | Other | Other: bone marrow and/or peripheral blood samples withdrawalA combined approach of Drug Sensitivity and Resistance Profiling (DSRP) and molecular-cytogenetic findings is used in order to prioritize compounds for tailored therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients to be enrolled in this study must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in the first relapse or must have failed primary induction chemotherapy (i.e., never attained a complete remission following an initial course of standard therapy for T-ALL/LBL or have a diagnosis of ETP-ALL [T-ALL with the following phenotype: Negative: CD1a-, CD8-, CD4-, CD5 (less than 75% of blasts); CD13+, CD33+, CD34+, CD117+, HLA-DR+, CD11b+, and/or CD65+ -in at least 25% of lymphoblasts
- Ages Eligible for Study: over 18 years
- Patients with T-ALL/LBL must have greater than 5% blasts in the bone marrow with or without extramedullary disease
- Patients with T-ALL/LBL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis
- Patients may have CNS 1 (WBC count in CSF <5 and having no blasts) or CNS 2 (WBC count in CSF <5 and having blasts) disease but not CNS 3 (WBC count in CSF ≥5 and having blasts)
Key exclusion criteria (6 listed)
- Significant organ compromise that will increase risk of toxicity or mortality
- Active serious infection not controlled by oral or intravenous antibiotics
- Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
- Known hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
- Active grade III-V cardiac failure as defined by the New York Heart Association Criteria
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 |
|---|---|---|
| bone marrow and/or peripheral blood samples withdrawalbone marrow and/or peripheral blood samples evaluation | Other | Biological evaluation |
Primary outcome
Drug sensitivity profile
Time frame: baseline
Frequencies of alternative therapies identified for T-ALL patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone marrow and/or peripheral blood samples withdrawal in people with T Acute Lymphoblastic Leukemia and Early T Acute Lymphoblastic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 10 sites 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 15 inclusion and 6 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug sensitivity profile (time frame: baseline). 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 7 Feb 2024.