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Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL

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
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

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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


Arm Intervention/treatment
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.
Other: bone marrow and/or peripheral blood samples withdrawal
bone marrow and/or peripheral blood samples evaluation




Primary Outcome Measures :
  1. 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
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Contact: Paola Fazi 0670390528 p.fazi@gimema.it
Contact: Enrico Crea 0670390514 e.crea@gimema.it

Locations
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Italy
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         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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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: May 21, 2021
Last Verified: May 2021

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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