To hear about similar clinical trials, please enter your email below
Trial Title:
the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma
NCT ID:
NCT05834751
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PEG-rhG-CSF
Description:
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for
mobilization
Arm group label:
experimental group
Other name:
pegfilgrastim
Intervention type:
Drug
Intervention name:
RhG-CSF
Description:
After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem
cell collection was completed.
Arm group label:
control group
Other name:
filgrastim
Summary:
A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy
and safety of pegylated recombinant human granulocyte stimulating factor injection in the
mobilization of autologous hematopoietic stem cells in lymphoma.
Detailed description:
The objective was to to evaluate the efficacy and safety of pegylated recombinant human
granulocyte stimulating factor injection in the mobilization of autologous hematopoietic
stem cells in lymphoma.
lymphoma patients who need to be prepared for autologous hematopoietic stem cell
transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times
the upper limit of normal value;
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-65 years old, regardless of gender;
2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell
transplantation;
3. KPS score ≥70;
4. Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal
value;
5. ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；
6. Patients can tolerate chemotherapy；
7. No active infection before chemotherapy;
8. The retrospective enrolled subjects are exempted from informed consent for data
collection, and the prospective enrolled subjects voluntarily participate in this
experiment and sign the informed consent form;
9. The researcher thinks that the subjects can benefit.
Exclusion Criteria:
1. Patients with megaspleen (when inhaling deeply, the spleen exceeds the right
umbilicus and/or below the umbilical level);
2. Those who have received mobilization and transplantation of allogeneic or autologous
hematopoietic stem cells before;
3. Subjects who have evidence of serious or uncontrollable systemic diseases (such as
unstable or irreparable respiratory, heart, liver or kidney diseases) according to
the researcher's judgment;
4. severe mental or nervous system diseases;
5. Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or
auxiliary materials of other preparations expressed by Escherichia coli, or have a
clear history of protein drug allergy, specific allergic reaction (asthma,
rheumatism, eczema dermatitis) or have had other serious allergic reactions;
6. pregnant or lactating female patients; Women of childbearing age refuse to accept
contraceptive measures; Those who plan to become pregnant during the study period;
7. The researcher judges other subjects who are not suitable to participate.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Contact:
Last name:
Ou Bai, doctor
Phone:
13039046656
Email:
oubai@163.com
Start date:
May 1, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Ou Bai, MD/PHD
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05834751
