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Generic plerixafor use at reduced-dose for mobilization on HSCT transplant
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic plerixafor | Active Comparator | Use a reduced-dose of generic plerixafor (0.12 mcg/Kg) |
|
| Placebo | Placebo Comparator | Use of a subcutaenous application of saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celrixafor | Drug | Use a reduced-dose of generic plerixafor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga G Cantú-RodrÃguez, MD | Universidad Autónoma de Nuevo León | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autónoma de Nuevo León | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31618456 | Result | Gutierrez-Aguirre CH, Alvarado-Navarro DM, Palomares-Leal A, Mejia-Jaramillo G, Salazar-Riojas R, Leon AG, Colunga-Pedraza PR, Sotomayor-Duque G, Jaime-Perez JC, Cantu-Rodriguez OG, Del Carmen Tarin-Arzaga L, Flores-Jimenez JA, Gomez-Almaguer D. Reduced-dose plerixafor as a mobilization strategy in autologous hematopoietic cell transplantation: a proof of concept study. Transfusion. 2019 Dec;59(12):3721-3726. doi: 10.1111/trf.15547. Epub 2019 Oct 16. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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Parallel study comparing placebo vs generic plerixafor
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The patient receive a subcutaenous application (placbe vs generic plerixafor)
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |