A Clinical Study on the Combination of Mitoxantrone Liposome Injection, Bendamustine, Etoposide, and Cytarabine for Pretreatment of Autologous Hematopoietic Stem Cell Transplantation in Patients with Lymphoma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Ningbo University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

30 Participants
are grouped into 1 trial group

Locations

This trial has no locations