- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05510544
Plerixafor for Poorly Mobilized Lymphoma
Efficacy and Safety of Plerixafor in Patients With Poorly Mobilized Lymphoma
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Weiping Liu, Dr
- Phone Number: +86-13522796323
- Email: dreaming2217@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Peking University Cancer Hospital & Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental arm: plerixafor, G-CSF
plerixafor in combination with granulocyte colony stimulating factor (G-CSF) for CD34+ HSC mobilization in poorly mobilized lymphoma patients
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the proportion of patients achieving ≥2 × 10ˆ6/kg CD34+ HSCs within ≤4 apheresis sessions.
Time Frame: within 4 days
|
within 4 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the proportion of patients achieving ≥5 × 106/kg CD34+ HSCs within ≤4 apheresis sessions.
Time Frame: within 4 days
|
within 4 days
|
time to collect ≥2 × 106/kg CD34+ HSCs,
Time Frame: at the end of therapy
|
at the end of therapy
|
time to collect ≥5 × 106/kg CD34+ HSCs,
Time Frame: at the end of therapy
|
at the end of therapy
|
The parameters for safety assessment included adverse event (AE), serious AE (SAE) and treatment emergent adverse event (TEAE)
Time Frame: at the end of therapy,7-21 days after mobilization collection
|
at the end of therapy,7-21 days after mobilization collection
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YF-PL-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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