Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04582487 |
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Recruitment Status :
Recruiting
First Posted : October 9, 2020
Last Update Posted : August 17, 2021
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Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| T Acute Lymphoblastic Leukemia Early T Acute Lymphoblastic Leukemia T-lymphoblastic Lymphoma Etp All | Other: bone marrow and/or peripheral blood samples withdrawal | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 32 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL |
| Actual Study Start Date : | May 19, 2021 |
| Estimated Primary Completion Date : | May 2024 |
| Estimated Study Completion Date : | May 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: bone marrow and/or peripheral blood samples withdrawal
bone marrow and/or peripheral blood samples evaluation |
Primary Outcome Measures :
- Drug sensitivity profile [ Time Frame: baseline ]Frequencies of alternative therapies identified for T-ALL patients
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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%
- 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:
- 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%
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582487
Contacts
| Contact: Paola Fazi | 0670390528 | p.fazi@gimema.it | |
| Contact: Enrico Crea | 0670390514 | e.crea@gimema.it |
Locations
| Italy | |
| Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica | Recruiting |
| Ancona, Italy | |
| Contact: Attilio Olivieri 3289558821 a.olivieri@univpm.it | |
| Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia | Recruiting |
| Bergamo, Italy | |
| Contact: Alessandro Rambaldi 3484526901 arambaldi@asst-pg23.it | |
| Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia | Recruiting |
| Bologna, Italy | |
| Contact: Cristina Papayannidis 3496484441 cristina.papayannidis@unibo.it | |
| Asst Degli Spedali Civili Di Brescia - Uo Ematologia | Recruiting |
| Brescia, Italy | |
| Contact: Erika Borlenghi 3402526539 erika.borlenghi@gmail.com | |
| Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia | Recruiting |
| Lecce, Italy | |
| Contact: Nicola Di Renzo 3388178577 direnzo.ematolecce@gmail.com | |
| Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia | Recruiting |
| Mestre, Italy | |
| Contact: Renato Bassan Renato.Bassan@aulss3.veneto.it | |
| Ematologia ed Immunologia Clinica | Recruiting |
| Perugia, Italy | |
| Contact: Cristina Mecucci cristina.mecucci@unipg.it | |
| Contact: Roberta La Starza | |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica | Recruiting |
| Roma, Italy | |
| Contact: Simona Sica 3355952379 simona.sica@Unicatt.it | |
| Aou Senese - Uoc Ematologia E Trapianti | Recruiting |
| Siena, Italy | |
| Contact: Monica Bocchia 3495792804 bocchia@unisi.it | |
| Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia | Recruiting |
| Vicenza, Italy | |
| Contact: Albana Lico albana.lico@aulss8.veneto.it | |
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT04582487 |
| Other Study ID Numbers: |
ALL2720 |
| First Posted: | October 9, 2020 Key Record Dates |
| Last Update Posted: | August 17, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |