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Trial Title:
Plerixafor for Poorly Mobilized Lymphoma
NCT ID:
NCT05510544
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Plerixafor
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Plerixafor,G-CSF
Description:
G-CSF: 10 μg/kg/day, subcutaneously injected, every morning from day 1 to day 8.
Plerixafor injection: 0.24 mg/kg/day, subcutaneous injection, starting on the 4th day,
once a day, up to 4 times in a row. Plerixafor injection and G-CSF administration site
should be separated. The interval between plerixafor injection and stem cell collection
was 10-11 hours.
Arm group label:
Experimental arm: plerixafor, G-CSF
Other name:
plerixafor, G-CSF
Summary:
Autologous hematopoietic stem cell transplantation is one of the effective means of
lymphoma treatment, but patients who receive transplantation in the absence of sufficient
stem cell numbers have a delay in stem cell engraftment and a markedly increased risk of
infection and emergence. Plerixafor injection is a strong and specific antagonist of
CXCR4. It can rapidly mobilize stem cells from bone marrow into peripheral blood
circulation by blocking the combination of SDF1 and CXCR4. Studies have shown that the
simultaneous use of plerixafor injection and G-CSF can collect more hematopoietic stem
cells in a certain period of time than cancer patients who use G-CSF alone. This
multicenter, open-label, single-arm study was designed to evaluate the efficacy and
safety of plerixafor injection for hematopoietic stem cell mobilization in poorly
mobilized lymphoma patients.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital & Institute
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhu
Email:
zj@bjcancer.org
Contact backup:
Last name:
Yuqin Song
Email:
songyuqin622@sina.com
Investigator:
Last name:
Yuqin Song
Email:
Principal Investigator
Start date:
December 19, 2022
Completion date:
January 31, 2024
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05510544