Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL (NCT04582487) | Clinical Trial Compass
UnknownNot Applicable
Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL
Italy32 participantsStarted 2021-05-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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/…
What they're measuring
1
Drug sensitivity profile
Timeframe: baseline
Trial details
NCT IDNCT04582487
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto