Lymphoma/Myeloma
Conditions
Interventions
experimental group:thiopefilgrastim double mobilization
control group:thiopefilgrastim single mobilization
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged (inclusive) 18 - (inclusive) 70 years; 2. Patients with confirmed lymphoma or multiple myeloma who received ASCT for the first time; 3. Suitable for ASCT; 4. In complete remission or partial remission; 5. At least 3 weeks from the start date of the last course of chemotherapy and/or anti-tumor therapy (including rituximab); 6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 7. Has recovered from all acute toxic reactions of previous chemotherapy or other anti-tumor treatments; 8. White blood cell (WBC) count > 2.0x 10^9/L, absolute neutrophil count (ANC) > 1.0 x 10^9/L, hemoglobin (HB) >= 70 g/L, platelet (PLT) count >= 50 x 10^9/L; 9. Serum aspartate aminotransferase (aspartate aminotransferase), serum alanine aminotransferase (alanine aminotransferase) and total bilirubin content = 45kg; 12. HIV negative; 13. Sign the Informed Consent Form (ICF); 14. Women of childbearing age have a negative urine or blood pregnancy test within 7 days of enrollment. All patients must agree to use highly effective contraception during the initiation and 3 months of receiving thiopefilgrastim in combination with VP-16 (including female patients of childbearing age and male patients whose spouses are females of childbearing age).
Exclusion criteria
Exclusion criteria: 1. According to the judgment of the investigator, coexisting diseases put the patient at a high risk of treatment complications; 2. Previously received autologous hematopoietic stem cell transplantation; 3. Previously received allogeneic hematopoietic stem cell transplantation; 4. Active central nervous system involvement; 5. Active brain metastases or cancerous meningitis; 6. Received pelvic radiotherapy; 7. PEG-rhG-CSF has been used within 2 weeks before the use of thiopefilgrastim combined with VP-16 in this study; 8. There is an active infection that requires antibiotic treatment; 9. Lactation period (female patients); 10. Patients who have had clinically significant (CS) arrhythmia (ventricular arrhythmia) or other serious conduction abnormalities within the past year, and who, according to the investigator's judgment, should be excluded; 11. Have received clinical study drug treatment within 4 weeks before enrollment; or be selected into another research program during the mobilization period; 12. Those who have drug allergy or metabolic disorder to the drugs in this program; 13. Mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful mobilization rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Excellent mobilization rate;Number of CD34 + cells collected;Collection times of successful mobilization; | — |
Countries
China
Contacts
Public ContactFang Jun
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed