Patients with hematologic malignancies
Conditions
Interventions
Chemotherapy-based Mobilization - Control Group:Standard Chemotherapy
Chemotherapy-based Mobilization - Experimental Group:Romiplostim N01 +Chemotherapy + G-CSF
Static Mobilization Cohort - Experimental Group:Romiplostim N01 + G-CSF
Static Mobilization Cohort - Control Group:G-CSF
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age Requirement: 18-70 years, regardless of gender. The upper age limit is set considering the tolerance and transplantation risks in elderly patients. 2.Disease Type: Confirmed hematologic malignancy, including multiple myeloma, non-Hodgkin lymphoma, Hodgkin lymphoma, etc., with an indication for autologous hematopoietic stem cell transplantation. 3.Disease Status: The disease is in complete remission (CR), partial remission (PR), or stable disease (SD), suitable for autologous transplantation.Organ Function: Cardiac ejection fraction>= 50%;normal lung function (DLCO>= 50%);normal liver function (bilirubin = 80 g/L, platelets >= 75 × 10^9/L, neutrophils >= 1.0 × 10^9/L. 6.Prior Treatment: Prior chemotherapy, radiotherapy, or targeted therapy is allowed, provided there is an adequate washout period. 7.Informed Consent: The patient fully understands the study content and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of prior mobilization failure: Previous receipt of any stem cell mobilization regimen (including G-CSF and/or chemotherapy mobilization) with a peak peripheral blood CD34+ cell count = 2.0×10^6 CD34+ cells/kg body weight) of hematopoietic stem cells. 2.History of thrombotic disease: A clear history of arterial thrombosis (e.g., myocardial infarction, cerebral infarction, unstable angina) or venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism) within 6 months prior to screening, and who have not received adequate anticoagulant therapy or have an unstable condition. Known hereditary or acquired thrombophilia (e.g., antiphospholipid syndrome, protein C/S deficiency, etc.), and the investigator judges the risk to outweigh the benefit. 3.Active infection: Unexplained fever (body temperature >=38.0°C) within 7 days prior to the planned start of mobilization therapy, and the investigator judges it to be a clinically significant active infection. 4.Pregnancy and lactation: Women who are pregnant (positive blood/urine pregnancy test) or breastfeeding, as well as subjects of childbearing potential (regardless of gender) unwilling to use effective contraception throughout the study period. 5.Drug allergy history: Known history of allergy to Romiplostim N01, recombinant proteins of E. coli origin, G-CSF, or any chemotherapeutic drug in the protocol. 6.Severe comorbidities and organ dysfunction: New York Heart Association (NYHA) functional class >= III, severe lung disease requiring continuous oxygen therapy, known cirrhosis, severe liver fibrosis or liver failure, chronic kidney disease requiring renal replacement therapy (dialysis), or any other medical condition judged by the investigator as likely to increase subject risk or interfere with study results. 7.Other conditions: Suffering from severe neurological or psychiatric disorders, including uncontrolled epilepsy, dementia, severe depression, etc., judged by the investigator to affect informed consent or protocol compliance. Any other serious medical condition judged by the investigator as likely to increase subject risk or interfere with the evaluation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a peripheral blood CD34+ cell count >=20/µL; | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection success rate;CD34+ cell total yield; | — |
Countries
China
Contacts
Public ContactJi Ma
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed