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This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).
This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled investigational study to evaluate granulocyte colony stimulating factor (G-CSF) plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkin's Lymphoma (NHL) patients (protocol AMD3100-3101 [NCT00103610]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF plus plerixafor | Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received plerixafor, prior to undergoing apheresis. |
| |
| G-CSF plus placebo | Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received placebo, prior to undergoing apheresis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| granulocyte colony-stimulating factor (G-CSF) | Drug |
| ||
| plerixafor |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610). | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from the AMD3100-3101 study (NCT00103610) who received at least one dose of study treatment (plerixafor or placebo)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29410180 | Derived | Micallef IN, Stiff PJ, Nademanee AP, Maziarz RT, Horwitz ME, Stadtmauer EA, Kaufman JL, McCarty JM, Vargo R, Cheverton PD, Struijs M, Bolwell B, DiPersio JF. Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report. Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2. |
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| Drug |
|
|
| Placebo | Drug |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| C088327 | plerixafor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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