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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

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Jan 1, 2025 to May 1, 2025v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06757478
Lead Sponsor First Affiliated Hospital of Ningbo University
Conditions
(from sponsor)
Lymphoma Patient
Related terms Lymphoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov