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Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5*10^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.
Participants with HD who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this study. The only changes to the standard of care is the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis and the collection of blood samples for pharmacokinetic (PK) analysis and pharmacodynamics (PD) analysis by CD34+ fluorescence-activated cell sorting (FACS) analysis. Blood samples for PK and CD34+ FACS analyses will be obtained prior to and after the first dose of plerixafor. Participants will undergo mobilization with G-CSF (10 µg/kg daily) and will receive plerixafor (240 µg/kg) on each day prior to apheresis. Participants will be apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg). After apheresis, all participants will be treated with high dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF plus plerixafor mobilization regimen. In the event that a sufficient number of cells for transplantation are not obtained from the collection, cells may be retained and pooled for transplantation at the investigator's discretion.
The primary endpoint is the proportion of HD participants who collect ≥5*10^6 CD34+ cells/kg with this mobilization regimen. The secondary endpoints include the safety of this mobilization regimen, the proportion of participants who collect ≥2*10^6 CD34+ cells/kg, the change in CD34+ cells circulating in the peripheral blood after a dose of plerixafor, and the number of days of apheresis required to obtain ≥5*10^6 CD34+ cells/kg. In addition, success of the transplantation will be evaluated by measuring the time to engraftment of PMNs and PLTs. Participants will be followed for 12 months to assess transplant durability.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Hodgkin's Disease (HD) | Experimental | Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF Plus Plerixafor | Drug | Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF | The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories. | Day 5 up to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Participant Counts of Adverse Events During the Treatment Period | Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant. See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia | St Louis | Missouri | 63110-1093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18940680 | Background | Cashen A, Lopez S, Gao F, Calandra G, MacFarland R, Badel K, DiPersio J. A phase II study of plerixafor (AMD3100) plus G-CSF for autologous hematopoietic progenitor cell mobilization in patients with Hodgkin lymphoma. Biol Blood Marrow Transplant. 2008 Nov;14(11):1253-61. doi: 10.1016/j.bbmt.2008.08.011. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Hodgkin's Disease (HD) | Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) [10 µg/kg each day (QD)] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Day 0 - approximately day 38 |
| Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF | The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories. | Day 5 up to day 9 |
| Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL). | Days 4-5 (first dose of plerixafor to apheresis) |
| Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg | Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data. | Day 5 up to day 9 |
| Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment | Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met. | Up to Month 13 (up to 12 months post transplant) |
| Number of Days Post Transplantation to Platelet (PLT) Engraftment | Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met. | Up to Month 13 (up to 12 months post transplant) |
| Number of Participants With a Durable Graft at 12 Months | Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment. | 13 months |
| Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor | Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered. | Day 4 |
| Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor | Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data. | Day 4 |
| Half-life (T1/2) Following a Single Dose of Plerixafor | Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor. | Day 4 |
| Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor | Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor. | Days 4-5 |
| Apparent Clearance (CL/F) of Single-dose Plerixafor | Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf). | Day 4-5 |
| Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor | The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant. | Day 4 |
| COMPLETED |
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| Follow-up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Hodgkin's Disease (HD) | Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF | The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories. | Intent to treat population which included all participants who received plerixafor. | Posted | Number | proportion of participants | Day 5 up to Day 9 |
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| Secondary | Overall Participant Counts of Adverse Events During the Treatment Period | Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant. See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious. | Safety population consisting of all participants who received G-CSF and/or plerixafor. | Posted | Number | participants | Day 0 - approximately day 38 |
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| Secondary | Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF | The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories. | Intent to treat population which included all participants who received plerixafor. | Posted | Number | proportion of participants | Day 5 up to day 9 |
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| Secondary | Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL). | Intent to treat population which included all participants who received plerixafor and had pre- and post-plerixafor CD34+ cell counts available; 3 participants had missing results data and were not included. | Posted | Mean | Standard Deviation | ratio | Days 4-5 (first dose of plerixafor to apheresis) |
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| Secondary | Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg | Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data. | Intent to treat population which included all participants who received plerixafor and achieved a target of ≥5*10^6 CD34+cells/kg | Posted | Number | participants | Day 5 up to day 9 |
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| Secondary | Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment | Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met. | Intent to treat population which included all participants who received plerixafor and had a transplant. | Posted | Median | Full Range | days | Up to Month 13 (up to 12 months post transplant) |
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| Secondary | Number of Days Post Transplantation to Platelet (PLT) Engraftment | Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met. | Intent to treat population which included all participants who received plerixafor and had a transplant. One participant's time to engraftment was unknown due to missing lab values. | Posted | Median | Full Range | days | Up to Month 13 (up to 12 months post transplant) |
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| Secondary | Number of Participants With a Durable Graft at 12 Months | Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment. | Intent to treat population which included all participants who received plerixafor and had a transplant. | Posted | Number | participants | 13 months |
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| Secondary | Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor | Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered. | The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data. | Posted | Mean | Standard Deviation | ng/mL | Day 4 |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor | Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data. | The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data. | Posted | Mean | Standard Deviation | hours | Day 4 |
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| Secondary | Half-life (T1/2) Following a Single Dose of Plerixafor | Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor. | The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data. | Posted | Mean | Standard Deviation | hours | Day 4 |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor | Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor. | The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 4-5 |
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| Secondary | Apparent Clearance (CL/F) of Single-dose Plerixafor | Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf). | The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data. | Posted | Mean | Standard Deviation | mL/hr | Day 4-5 |
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| Secondary | Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor | The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant. | The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data. | Posted | Mean | Standard Deviation | mL | Day 4 |
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Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8).
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Each AE table includes all events, regardless of reported relationship to study treatment or grade.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Hodgkin's Disease (HD) | Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg). | 0 | 22 | 17 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site discharge | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site irritation | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Pallor | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Genzyme Medical Information | Genzyme Corporation | 800-745-4447 |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| 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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