Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation
March 24, 2025 updated by: Cesar Homero Gutierrez-Aguirre, Hospital Universitario Dr. Jose E. Gonzalez
Dose-reduced Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Patients with Lymphoma and Myeloma
Generic plerixafor use at reduced-dose for mobilization on HSCT transplant
Study Overview
Detailed Description
The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant.
Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 64460
- Universidad Autonoma de Nuevo Leon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
- Patients > 18 years old who signed our informed consent
- Normal CBC count (Hb > 10, WBC 4.0-11.00, plt > 100,000)
Exclusion Criteria:
- Patients with HIV, Hepatitis C, Hepatitis B diagnosis
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Generic plerixafor
Use a reduced-dose of generic plerixafor (0.12 mcg/Kg)
|
Use a reduced-dose of generic plerixafor
|
|
Placebo Comparator: Placebo
Use of a subcutaenous application of saline solution
|
Use a reduced-dose of generic plerixafor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest
Time Frame: 1 year
|
The objective of this study is to demonstrate that the use of a low dose of the generic form of plerixafor is effective in increasing the amount of hematopoietic cells (stem cells).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Olga G Cantú-Rodríguez, MD, Universidad Autonoma de Nuevo Leon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2019
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
March 21, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 27, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE19-00013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.