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| ID | Type | Description | Link |
|---|---|---|---|
| MOZ14409 | Other Identifier | Genzyme | |
| U1111-1131-0145 | Other Identifier | UTN |
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The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.
Eligible patients who are unable to achieve adequate apheresis cell counts may enter an Open-Label Rescue Period where they will receive plerixafor, following the same study schedule as during the Double-Blind Treatment Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF + plerixafor | Experimental | Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses. |
|
| G-CSF + Placebo | Placebo Comparator | Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granulocyte-colony stimulating factor (G-CSF) | Drug | 10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis | Days 5- Day8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis | Day 5 - Day 8 | |
| Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg | Up to achieve the target of collecting ≥2 × 10^6 CD34+ cells/kg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 156017 | Beijing | 100034 | China | |||
| Investigational Site Number 156001 |
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|
| Plerixafor | Drug | 0.24 mg/kg/day subcutaneous injection |
|
|
| Placebo | Drug | 0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection |
|
| Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg | Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg |
| Total number of CD34+ cells collected | Day 5 - Day 8 |
| Time from transplantation to neutrophil and platelet (PLT) engraftment | up to 30 days post-transplantation |
| Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed |
| Maximum plasma concentration (Cmax) | Day 4 - Day 5 |
| Time to reach Cmax (Tmax) | Day 4 - Day 5 |
| Area Under the Curve 0 to 10 hours post-dose (AUC0-10) | Day 4 - Day 5 |
| Area Under the Curve 0 to last observed concentration (AUClast) | Day 4 - Day 5 |
| Area Under the Curve (AUC) | Day 4 - Day 5 |
| Percentage of extrapolation of AUC (AUCext) | Day 4 - Day 5 |
| Half life (T1/2) | Day 4 - Day 5 |
| Volume of distribution (Vz/F) | Day 4 - Day 5 |
| Total body clearance (CL/F) | Day 4 - Day 5 |
| Peripheral blood CD34+ cell counts (Pharmacodynamic analysis) | Day 4 - Day 5 |
| The fold-increase in the number of circulating CD34+ following the first dose of plerixafor or placebo, with the first apheresis day (Day 5) value serving as the primary estimate | Day 5 - Day 8 |
| Beijing |
| 100044 |
| China |
| Investigational Site Number 156005 | Beijing | 100071 | China |
| Investigational Site Number 156002 | Beijing | 100142 | China |
| Investigational Site Number 156003 | Beijing | 100730 | China |
| Investigational Site Number 156020 | Chongqing | 400037 | China |
| Investigational Site Number 156016 | Fuzhou | 350001 | China |
| Investigational Site Number 156021 | Guangzhou | 510060 | China |
| Investigational Site Number 156011 | Hangzhou | 310003 | China |
| Investigational Site Number 156018 | Nanjing | 210029 | China |
| Investigational Site Number 156009 | Shanghai | 200025 | China |
| Investigational Site Number 156010 | Suzhou | 215006 | China |
| Investigational Site Number 156008 | Tianjin | 300020 | China |
| Investigational Site Number 156013 | Wuhan | 430022 | China |
| Investigational Site Number 156015 | Xi'an | 710038 | China |
| Investigational Site Number 156022 | Zhengzhou | 450008 | China |
| 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 |
| D017829 | Granisetron |
| D000069585 | Filgrastim |
| 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 |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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