Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL
NCT ID: NCT04582487
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2021-05-19
2024-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Biological evaluation
A combined approach of Drug Sensitivity and Resistance Profiling (DSRP) and molecular-cytogenetic findings is used in order to prioritize compounds for tailored therapies.
bone marrow and/or peripheral blood samples withdrawal
bone marrow and/or peripheral blood samples evaluation
Interventions
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bone marrow and/or peripheral blood samples withdrawal
bone marrow and/or peripheral blood samples evaluation
Eligibility Criteria
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Inclusion Criteria
* 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%
* 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
Exclusion Criteria
* 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%
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Locations
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Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, , Italy
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
Bergamo, , Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, , Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce, , Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre, , Italy
Ematologia ed Immunologia Clinica
Perugia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, , Italy
Aou Senese - Uoc Ematologia E Trapianti
Siena, , Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza, , Italy
Countries
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Central Contacts
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Facility Contacts
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Roberta La Starza
Role: backup
Other Identifiers
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ALL2720
Identifier Type: -
Identifier Source: org_study_id
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