ENSAYO CLÍNICO

Reclutando

Fase III

Coagulopatías hemorrágicas, Leucemia linfática crónica y otros SLPC, Leucemia mieloide aguda, Linfoma no Hodgkin, Terapia celular y T-CARs, Trasplante de progenitores hematopoyéticos, Leucemia mieloide crónica, Linfoma, Leucemia

Abierto

Septiembre, 2025

Junio, 2032

Patients aged 18 years with a confirmed diagnosis of CLL/SLL, per the iwCLL 2018 criteria (Hallek et al 2018).
Patients must have 1 prior therapy for CLL/SLL. For each line of therapy, patients must receive at least 2 cycles of this therapy.
For patients who received a BCL2i, only those with CLL/SLL who received BCL2i in the first line setting with fixed duration therapy, have a remission for 3 years, and have a time interval of 2 years from the last dose of BCL2i to screening, are eligible. Patients should be informed about their options to choose other approved CLL/SLL therapies in this setting.
Indications for CLL/SLL therapy are met by one of the criteria per the iwCLL 2018 criteria, with minor modification as discussed in the main protocol.
Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2.
Adequate marrow function as defined by: Absolute neutrophil count 1.0 x 109 cells/L with an exception for patients with bone marrow involvement, in which case the absolute neutrophil count must be 0.75 x 109 cells/L (without growth factor support within the past 7 days). Platelet counts 75 x 109 cells/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), the platelet count should be 30 x 109 cells/L (without growth factor support or transfusion within the past 7 days). Hemoglobin > 75 g/L (may be posttransfusion).
Adequate liver function as indicated by aspartate aminotransferase and alanine aminotransferase 2.5 x upper limits of normal (ULNs) value; serum total bilirubin 1.5 x ULNs (unless documented Gilbert syndrome where total bilirubin 3 x ULNs).
Adequate renal function, defined by a value 30 mL/min, determined either by creatinine clearance directly measured with a 24-hour urine collection or via estimated glomerular filtration rate calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation.
Life expectancy > 6 months.

No active infection including hepatitis B or C virus or HIV at the time of study treatment initiation.
No active prolymphocytic leukemia or currently suspected Richters transformation at the time of consideration for study.
No ongoing clinically significant cardiovascular or pulmonary disease that prevents participation.
No central nervous system involvement by CLL/SLL.
No history of prior or active malignancy within 18 months, except for conditions as listed below and as long as patients have recovered from the acute side effects incurred because of previous therapy: Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Localized prostate cancer with Gleason score 6 or controlled prostate cancer with androgen deprivation treatment. Treated early-stage breast cancer with or without hormonal therapy.
No other active antineoplastic treatment.
No CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers.

cd20, chronic leukemia, diffuse large b-cell lymphoma (dlbcl), non germinal center b-cell type, donor lymphocyte infusion, factor xi, leukemia, lymphocytic, lymphoma, non germinal center b-cell type, ph + acute lymphoblastic leukemia, relapsed/refractory all, small lymphocytic lymphoma