DK-CLIC-1901 CAR T-cells for treatment of patients with relapsed/refractory CD19 positive hematological malignancies (DAN-CART 1901)

Conditions

Acute Lymphoblastic Leukemia and B-cell Non Hodgkin Lymphoma

Brief summary

CRS: registration according to international grading system[31]. Endpoints include proportion of patients experiencing CRS of all grades and CRS grade 3-4, ICANS: registration according to international grading system[31]. Endpoints include proportion of patients experiencing ICANS of all grades and ICANS grade 3-4., Treatment with tocilizumab and/or glucocorticoids for CRS/ICANS., Cytopenia, including ICAHT grade ≥3 at day +28 and time to reach acceptable levels of neutrophils (≥1,.0 in three consecutive days), thrombocytes (≥100 in three consecutive days) and hemoglobin after CAR T-cell infusion., Episodes of neutropenic fever (temperature >38.5 °C and neutrophils <0.5), Admission at the intensive care unit (ICU) or pediatric intensive care unit (PICU), Death from any cause

Detailed description

Response rates defined as complete response, partial response, stable response or progressive disease, Overall survival (OS), progression-free survival (PFS), non-relapse mortality (NRM) and treatment with allogeneic hematopoietic stem cell transplantation (HSCT)

Related papers

No related papers found yet.

Interventions

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

DRUGDK-CLIC-1901

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CRS: registration according to international grading system[31]. Endpoints include proportion of patients experiencing CRS of all grades and CRS grade 3-4, ICANS: registration according to international grading system[31]. Endpoints include proportion of patients experiencing ICANS of all grades and ICANS grade 3-4., Treatment with tocilizumab and/or glucocorticoids for CRS/ICANS., Cytopenia, including ICAHT grade ≥3 at day +28 and time to reach acceptable levels of neutrophils (≥1,.0 in three consecutive days), thrombocytes (≥100 in three consecutive days) and hemoglobin after CAR T-cell infusion., Episodes of neutropenic fever (temperature >38.5 °C and neutrophils <0.5), Admission at the intensive care unit (ICU) or pediatric intensive care unit (PICU), Death from any cause	—

Measure

Time frame

CRS: registration according to international grading system[31]. Endpoints include proportion of patients experiencing CRS of all grades and CRS grade 3-4, ICANS: registration according to international grading system[31]. Endpoints include proportion of patients experiencing ICANS of all grades and ICANS grade 3-4., Treatment with tocilizumab and/or glucocorticoids for CRS/ICANS., Cytopenia, including ICAHT grade ≥3 at day +28 and time to reach acceptable levels of neutrophils (≥1,.0 in three consecutive days), thrombocytes (≥100 in three consecutive days) and hemoglobin after CAR T-cell infusion., Episodes of neutropenic fever (temperature >38.5 °C and neutrophils <0.5), Admission at the intensive care unit (ICU) or pediatric intensive care unit (PICU), Death from any cause

—

Secondary

Measure	Time frame
Response rates defined as complete response, partial response, stable response or progressive disease, Overall survival (OS), progression-free survival (PFS), non-relapse mortality (NRM) and treatment with allogeneic hematopoietic stem cell transplantation (HSCT)	—

Countries

Denmark

Outcome results

None listed