This is a single-arm, open, single-center clinical study. Patients with lymphoma who were to undergo autologous hematopoietic stem cell transplantation were pretreated with mitoxantrone hydrochloride liposome injection combined with standard doses of bendamustine, etoposide, and cytarabine before transplantation, in order to explore the safety and efficacy of this combined pretreatment regimen.
Tests were performed during the study to observe efficacy, safety, and tolerability. The treatment period was from pre-treatment to +28 days after transplantation and +28 days after stem cells were transfused. The follow-up period was followed up once a month for 6 months, every 3 months for 6 months to 2 years, and every 6 months for 2 years to 3 years after stem cell reinfusion. All subjects underwent protocol-mandated examinations during treatment to observe safety, tolerability, and efficacy.
Consolidation therapy after first-line induction chemotherapy for aggressive non-Hodgkin lymphoma with poor prognostic factors;
It is suitable for salvage treatment of chemotherapy-sensitive non-Hodgkin lymphoma after recurrence;
and salvage treatment of relapsed or primary refractory Hodgkin lymphoma that is sensitive to chemotherapy.
Bone marrow hematopoietic function is basically normal, blood routine: WBC ≥ 2.0×10^9/L, ANC ≥ 1.0×10^9/L, PLT ≥50×10^9/L, Hb ≥ 80 g/L. If the peripheral blood indexes were abnormal due to lymphoma invading bone marrow or spleen, the researchers could determine whether the patients were suitable for inclusion.
1. Received doxorubicin or anthracycline treatment in the past, and the total cumulative dose of doxorubicin was > 360 mg/m² (1 mg doxorubicin is equivalent to 2 mg epirubicin for other anthracycline drugs).
Lymphoma subjects for autologous hematopoietic stem cell transplantation
Cohort
Prospective
Not listed
Safety evaluation
Adverse reactions associated with pretreatment were evaluated in the United States in 2017. Published by the Department of Health and Human Services, see Glossary of Adverse Reactions Assessment (CTCAE5.0). Transplant-related mortality (TRM) was defined as treatment-related mortality not associated with the primary disease within 100 days of transplantation.
Overall survival (OS) time
From transplant initiation to death or last follow-up
Progression-free survival (PFS) time
Time from the start of transplantation to disease progression, recurrence, death, or last follow-up
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
