Plerixafor for Poorly Mobilized Lymphoma

This is an interventional treatment trial for Lymphoma Read More

Inclusion Criteria:

• Pathological examination confirmed lymphoma;
• Age 18 to 70 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Suitable for autologous peripheral blood hematopoietic stem cell transplantation and plan to use autologous peripheral blood hematopoietic stem cell transplantation for treatment, and obtain partial remission (PR) or complete remission (CR) after anti-tumor therapy;
• Negative bone marrow examination within 45 days (the standard is that the results of bone marrow smear, biopsy and flow cytometry are all negative);

• Any one of the conditions for poor mobilization:

  • Poor steady-state mobilization: rest for 3 weeks or more after the last chemotherapy, give G-CSF 10 μg/kg/day, and peripheral blood CD34+ cells <10/μL on the 4th day of G-CSF treatment;

    • Poor chemotherapy mobilization: When chemotherapy + G-CSF is used for mobilization, on the 7th to 10th day after chemotherapy, or the expected white blood cell (WBC) drops to the lowest point, each participating center starts to give G-CSF 10 μg/kg according to the diagnosis and treatment standards. Treatment, until WBC recovered from the lowest point to 4 × 10ˆ9/L (applicable to WBC decreased to <4 × 10ˆ9/L after chemotherapy) or G-CSF treatment on the 4th day (applicable to WBC after chemotherapy failed to drop to <4 ×10ˆ9/L) CD34+ cells in peripheral blood <10/μL;

      • The amount of CD34+ cells collected on the first day of collection is less than 1×10ˆ6/kg;

        • The amount of CD34+ cells collected 2 days before collection is less than 1.5×10ˆ6/kg;
• Informed consent and signed informed consent voluntarily.

Exclusion Criteria:

• suffering from chronic lymphocytic leukemia;
• Hematopoietic stem cell collection has been performed in the past;
• Received autologous or allogeneic hematopoietic stem cell transplantation in the past;
• Received any radio-immunotherapy in the past (including tiimumab or tosilimumab, etc.);
• Received pelvic radiotherapy in the past;
• Major surgery (excluding diagnostic surgery) within 4 weeks before the first study drug administration;
• Have been vaccinated or will be vaccinated with live vaccines within 30 days before the first study drug administration;
• Human immunodeficiency virus (HIV) positive;

• Patients who meet any of the following laboratory criteria:

  • White blood cell (WBC) count ≤2.5×10ˆ9/L;

    • Absolute neutrophil count (ANC) <1.5×10ˆ9/L;

      • Platelet (PLT) count ≤100×10ˆ9/L;

        • Creatinine clearance ≤50mL/min;

          • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin ≥ 2.5 times the upper limit of normal;
• Those with active infection, including unexplained fever (axillary temperature >37.3℃) or those who need antibiotic, antiviral or antifungal treatment within 7 days before the first use of G-CSF;
• are pregnant or breastfeeding;