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Bio-CAR-T BS Study

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About this study

The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.

Condition
Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Acute Lymphoblastic Leukemia (ALL)
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Who can join

Age
18 to 70 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Study condition: Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Acute Lymphoblastic Leukemia (ALL)
  • Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed/refractory after two lines of treatments;
  • Adequate performance status (0 or 1);
  • Adequate organ function;
  • No active or uncontrolled infections;
  • No thrombo-embolisms within the last 6 months;
  • Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
  • Life expectancy of at least 3 months.

Exclusion 8

  • Patients with B-cell-ALL \> 25 years
  • Patients with DLBCL \<18 or \>70 years
  • Patients with PMBCL \<18 or \>70 years
  • Performance status \> 1;
  • Active or uncontrolled infections;
  • Thrombo-embolisms within the last 6 months;
  • Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
  • Life expectancy \< 3 months.

Where

1 site, 1 recruiting

ASST Spedali Civili di Brescia

Brescia, Italy

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.