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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1152-4309 | Other Identifier | UTN |
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Primary Objective:
To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in 4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.
Secondary Objectives:
Total study duration for a participant can be approximately up to 68 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| granulocyte colony-stimulating factor alone | Active Comparator | G-CSF administered up to 8 days |
|
| granulocyte colony-stimulating factor plus plerixafor | Experimental | G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plerixafor GZ316455 | Drug | Pharmaceutical form:vial Route of administration: subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis | Day 5 to Day 8 of the apheresis/treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis | Day 5 to Day 8 of the apheresis/treatment period | |
| Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392005 | Chiba | Japan | ||||
| Investigational Site Number 392011 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30043330 | Derived | Matsue K, Kumagai K, Sugiura I, Ishikawa T, Igarashi T, Sato T, Uchiyama M, Miyamoto T, Ono T, Ueda Y, Kiguchi T, Sunaga Y, Sasaki T, Suzuki K. Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study. Int J Hematol. 2018 Nov;108(5):524-534. doi: 10.1007/s12185-018-2505-4. Epub 2018 Jul 24. |
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| Filgrastim | Drug | Pharmaceutical form:vial Route of administration: subcutaneous injection |
|
| Day 5 to Day 8 of the apheresis/treatment period |
| Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells | Day 5 to Day 8 of the apheresis/treatment period |
| Total number of CD34+ cells/kg collected over up to 4 apheresis | Day 5 to Day 8 of the apheresis/treatment period |
| The relative increase (ratio) of peripheral blood (PB) CD34+ cell count (cells/μL) | From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only |
| Number of participants with adverse events | Up to 68 days |
| Change from baseline in clinical laboratory measurements | Up to 68 days |
| Fukuoka |
| Japan |
| Investigational Site Number 392014 | Fukuyama-Shi | Japan |
| Investigational Site Number 392010 | Hamamatsu | Japan |
| Investigational Site Number 392006 | Kamogawa-Shi | Japan |
| Investigational Site Number 392003 | Kobe | Japan |
| Investigational Site Number 392008 | Kurashiki-Shi | Japan |
| Investigational Site Number 392015 | Ota-Shi | Japan |
| Investigational Site Number 392004 | Sapporo | Japan |
| Investigational Site Number 392001 | Shibuya-Ku | Japan |
| Investigational Site Number 392009 | Suwa-Shi | Japan |
| Investigational Site Number 392007 | Toyohashi | Japan |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C088327 | plerixafor |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| 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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