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

February 6, 2024 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
        • Contact:
      • Bergamo, Italy
        • Recruiting
        • Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
        • Contact:
      • Bologna, Italy
        • Recruiting
        • Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
        • Contact:
      • Brescia, Italy
        • Recruiting
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
        • Contact:
      • Lecce, Italy
        • Recruiting
        • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
        • Contact:
      • Mestre, Italy
      • Perugia, Italy
        • Recruiting
        • Ematologia ed Immunologia Clinica
        • Contact:
        • Contact:
          • Roberta La Starza
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
        • Contact:
      • Siena, Italy
        • Recruiting
        • Aou Senese - Uoc Ematologia E Trapianti
        • Contact:
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug sensitivity profile
Time Frame: baseline
Frequencies of alternative therapies identified for T-ALL patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALL2720

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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