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

NCT04582487 | Recruiting

• 1 other identifier: ALL2720
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 10

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.

Conditions

T Acute Lymphoblastic Leukemia; Early T Acute Lymphoblastic Leukemia; T-lymphoblastic Lymphoma; Etp All

Outcome Measures

Primary Outcomes (1)

• Drug sensitivity profile

  Frequencies of alternative therapies identified for T-ALL patients

  baseline

Study Arms (1)

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.

Other: bone marrow and/or peripheral blood samples withdrawal

Interventions

bone marrow and/or peripheral blood samples withdrawal OTHER

bone marrow and/or peripheral blood samples evaluation

Biological evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (10)

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica

Ancona, Italy

RECRUITING

Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia

Bergamo, Italy

RECRUITING

Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

Bologna, Italy

RECRUITING

Asst Degli Spedali Civili Di Brescia - Uo Ematologia

Brescia, Italy

RECRUITING

Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia

Lecce, Italy

RECRUITING

Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia

Mestre, Italy

RECRUITING

Ematologia ed Immunologia Clinica

Perugia, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, Italy

RECRUITING

Aou Senese - Uoc Ematologia E Trapianti

Siena, Italy

RECRUITING

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

Vicenza, Italy

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Paola Fazi

CONTACT

0670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514; e.crea@gimema.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 9, 2020
• Study Start: May 19, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

IT (10)