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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019340-40 | EudraCT Number | ||
| MOZ15609 | Other Identifier | Genzyme other study code |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages:
All participating patients will receive a standard mobilization regimen as per study site practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage 1 (dose escalation), and for those patients randomized to the plerixafor plus standard mobilization treatment arm in Stage 2 (randomized, comparative).
Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plerixafor 160 μg/kg | Experimental | Patients will receive subcutaneous (SC) injection of 160 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions). |
|
| Plerixafor 240 μg/kg | Experimental | Patients will receive subcutaneous (SC) injection of 240 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions). |
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| Plerixafor 320 μg/kg | Experimental | Patients will receive subcutaneous (SC) injection of 320 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plerixafor | Drug | 160 μg/kg subcutaneous (SC) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving at least a doubling of peripheral blood CD34+ count during Stage 2 | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of apheresis required to reach ≥2 × 10^6 CD34+ cells/kg | During Stage 1 and Stage 2 | Up to 5 days |
| Yield of CD34+ cells for each apheresis | During Stage 1 and Stage 2 |
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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 51 | Ghent | 9000 | Belgium | |||
| Investigational Site Number 81 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36163427 | Derived | Sebastien B, Cheverton P, Magnin C, Aouni J, Castan R. Development and validation of a predictive model to guide the use of plerixafor in pediatric population. Bone Marrow Transplant. 2022 Dec;57(12):1827-1832. doi: 10.1038/s41409-022-01831-2. Epub 2022 Sep 26. | |
| 32127657 | Derived | Morland B, Kepak T, Dallorso S, Sevilla J, Murphy D, Luksch R, Yaniv I, Bader P, Rossler J, Bisogno G, Maecker-Kolhoff B, Lang P, Zwaan CM, Sumerauer D, Krivan G, Bernard J, Liu Q, Doyle E, Locatelli F. Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC). Bone Marrow Transplant. 2020 Sep;55(9):1744-1753. doi: 10.1038/s41409-020-0836-2. Epub 2020 Mar 3. |
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| plerixafor |
| Drug |
240 μg/kg subcutaneous (SC) injection |
|
| plerixafor | Drug | 320 μg/kg subcutaneous (SC) injection |
|
| Up to 5 days |
| Total CD34+ cell yield | During Stage 1 and Stage 2 | Up to 5 days |
| Percentage of patients proceeding to transplant | During Stage 1 and Stage 2 | Within 6 months of last apheresis |
| Percentage of patients successfully engrafting | During Stage 1 and Stage 2 | 3, 6, 12 and 24 months post-transplant |
| Percentage of patients with durable engraftment | During Stage 1 and Stage 2 | 3, 6, 12 and 24 months post-transplant |
| Summary of adverse events (AEs) | During Stage 1 and Stage 2 | Up to 24 months after last transplant or 24 months after last dose (for patients that do not transplant within 6 months of last apheresis) |
| Duration of hospitalizations (planned or unplanned) | During Stage 1 and Stage 2 | Throughout the duration of the study |
| Mobilization of tumor cells into peripheral blood | During Stage 1 and Stage 2 | Up to 5 days |
| Relapse rates | During Stage 1 and Stage 2 | 3, 6, 12 and 24 months post-transplant |
| Occurrence of secondary malignancies | During Stage 1 and Stage 2 | 3, 6, 12 and 24 months post-transplant |
| Incidence of primary and secondary graft failure | During Stage 1 and Stage 2 | 3, 6, 12 and 24 months post-transplant |
| Time to secondary graft failure | During Stage 1 and Stage 2 | Up to 24 months post-transplant |
| Survival rates | During Stage 1 and Stage 2 | 3, 6, 12 and 24 months post-transplant |
| Brno |
| 62500 |
| Czechia |
| Investigational Site Number 82 | Praha 5 - Motol | 15006 | Czechia |
| Investigational Site Number 61 | København Ø | 2100 | Denmark |
| Investigational Site Number 42 | Lyon | 69373 | France |
| Investigational Site Number 43 | Paris | 75248 | France |
| Investigational Site Number 33 | Frankfurt am Main | 60590 | Germany |
| Investigational Site Number 34 | Freiburg im Breisgau | 79106 | Germany |
| Investigational Site Number 35 | Hamburg | 20246 | Germany |
| Investigational Site Number 31 | Hanover | 30625 | Germany |
| Investigational Site Number 36 | München | 80337 | Germany |
| Investigational Site Number 83 | Budapest | 1097 | Hungary |
| Investigational Site Number 92 | Petah Tikva | 4920235 | Israel |
| Investigational Site Number 91 | Tel Aviv | 64239 | Israel |
| Investigational Site Number 21 | Genova | 16100 | Italy |
| Investigational Site Number 24 | Milan | 20133 | Italy |
| Investigational Site Number 23 | Padova | 35128 | Italy |
| Investigational Site Number 22 | Roma | 00165 | Italy |
| Investigational Site Number 26 | Torino | 10126 | Italy |
| Investigational Site Number 72 | Amsterdam | 1105 AZ | Netherlands |
| Investigational Site Number 71 | Rotterdam | 3015 GJ | Netherlands |
| Investigational Site Number 85 | Krakow | 30-663 | Poland |
| Investigational Site Number 84 | Wroclaw | 50-368 | Poland |
| Investigational Site Number 94 | Barcelona | 08035 | Spain |
| Investigational Site Number 93 | Madrid | 28009 | Spain |
| Investigational Site Number 11 | Birmingham | B4 6NH | United Kingdom |
| Investigational Site Number 13 | Glasgow | G51 4TF | United Kingdom |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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