Non-Hodgkin's LymphomaPhase 4NCT01164475
Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms
A Phase 4 study testing Granulocyte-colony stimulating factor (G-CSF), Fixed Dose Plerixafor and Weight-Based Plerixafor in people with Non-Hodgkin's Lymphoma, run by Genzyme, a Sanofi Company at 7 sites in 4 countries.
Trial summary
The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Granulocyte-colony stimulating factor (G-CSF), Fixed Dose Plerixafor and Weight-Based Plerixafor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Oct 2010to Feb 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 78 years (inclusive)
- Patients diagnosed with NHL who were to receive treatment with an autologous peripheral stem cell transplant for the first time
- Biopsy-confirmed diagnosis of NHL (chronic lymphocytic leukemia and all variants were excluded)
- Weight less than or equal to 70 kg
- In first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first or second-line therapy only
- At least 4 weeks since last cycle of chemotherapy and/or other cancer therapy including rituximab
Show all 17Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovered from all acute toxic effects of prior chemotherapy
- Negative for human immunodeficiency virus (HIV), active hepatitis B, and active hepatitis C from assessments performed within 3 months before signing informed consent
- Signed informed consent form (ICF)
- White blood cell count (WBC) greater than (>) 2.5*10^9 per liter (L)
- Absolute neutrophil count (ANC) >1.5*10^9/L
- Platelet (PLT) count >100*10^9/L
- Creatinine clearance >=80 milliliter per minute (mL/min) (estimated by Cockcroft-Gault formula or 24 hour urine collection)
- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT), and total bilirubin less than 2.5*upper limit of normal
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- All patients agreed to an effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential)
Who cannot join
- A co-morbid condition which, in the view of the Investigator(s), rendered the patient at high risk from treatment complications
- Failed previous hematopoietic stem cell (HSC) collections or collection attempts
- Prior autologous or allogeneic transplant
- Less than 6 weeks off 1,3-bis (2-chloroethyl)-1-nitroso-urea (BCNU) prior to first dose of G-CSF
- Active central nervous system involvement, active brain metastases, or any history of carcinomatous meningitis (active or inactive)
- Bone marrow involvement >20 percent (%), as assessed by bone marrow biopsy within 4 months of the first screening assessment, unless a bone marrow biopsy was performed immediately prior to the last chemotherapy and was negative and the patient responded to last chemotherapy achieving a complete or partial remission
Show all 15Show fewer
- Received radiation therapy to the pelvis
- Received granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim within 3 weeks prior to the first dose of granulocyte colony stimulating factor (G-CSF) for mobilization
- Received G-CSF within 14 days prior to the first dose of G-CSF for mobilization
- Received prior radio-immunotherapy with ibritumomab tiuxetan or tositumomab iodine
- Active infection, including unexplained fever (>38.1 degree Celsius / 100.4 Fahrenheit), or antibiotic, antiviral, or antifungal therapy within 7 days prior to the first dose of G-CSF
- Positive pregnancy test (female patients)
- Lactating (female patients)
- Abnormal electrocardiogram (ECG) with clinically significant rhythm disturbance (ventricular arrhythmias) or other conduction abnormality in the last year that, in the opinion of the Investigator(s), warranted exclusion of the patient from the trial
- Previously received experimental therapy within 4 weeks of enrolling or who were currently enrolled in another experimental protocol during the G CSF and plerixafor treatment period
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States2 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
City of Hope National Medical Center
Duarte, California, 91010
South Korea2 sites
Samsung Medical Center
Seoul, 135-710
St. Mary's Hospital
Seoul, 137-701
Taiwan2 sites
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 10002
About this study
Official title: A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect ≥5 x 10^6 CD34+ Cells/kg in ≤4 Days and to Evaluate the Difference in Total Systemic Exposure in Patients With Non-Hodgkin's Lymphoma Weighing ≤70 kg
The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Granulocyte-colony stimulating factor (G-CSF), Fixed Dose Plerixafor, Weight-Based Plerixafor
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte-colony stimulating factor (G-CSF)Drug
Also called Filgrastim
Fixed Dose PlerixaforDrug
Also called Mozobil, AMD3100
Weight-Based PlerixaforDrug
Also called Mozobil, AMD3100
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose Plerixafor | Experimental | 10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. Receives: Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Fixed Dose Plerixafor |
| Weight-Based Plerixafor | Active comparator | G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. Receives: Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Weight-Based Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Measured: Day 5 up to Day 8
Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])
Measured: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Secondary outcomes (8)
Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >= 2*10^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Measured: Day 5 up to Day 8
Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg
Measured: Day 5 up to Day 8
Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg
Measured: Day 5 up to Day 8
Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.
Measured: Day 5 up to Day 8
Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor
Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.
Measured: Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)
Maximum Observed Plasma Concentration (Cmax)
Measured: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Terminal Elimination Half-life (T1/2)
T1/2 is the time required for the plasma concentration to decrease to one half.
Measured: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164475
- Sponsor's protocol ID
- MOZ11809
- Other IDs
- MSC12830
- Status last verified
- Feb 2014
- First submitted
- 9 Jul 2010
- Last updated
- 25 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect ≥5 x 10^6 CD34+ Cells/kg in ≤4 Days and to Evaluate the Difference in Total Systemic Exposure in Patients With Non-Hodgkin's Lymphoma Weighing ≤70 kg
- ClinicalTrials.gov ID
- NCT01164475
- Acronym / sponsor ID
- MOZ11809
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Posted 31 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Dose Plerixafor | Experimental | Drug: Granulocyte-colony stimulating factor (G-CSF), Drug: Fixed Dose Plerixafor10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. |
| Weight-Based Plerixafor | Active comparator | Drug: Granulocyte-colony stimulating factor (G-CSF), Drug: Weight-Based PlerixaforG-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18 to 78 years (inclusive)
- Patients diagnosed with NHL who were to receive treatment with an autologous peripheral stem cell transplant for the first time
- Biopsy-confirmed diagnosis of NHL (chronic lymphocytic leukemia and all variants were excluded)
- Weight less than or equal to 70 kg
- In first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first or second-line therapy only
Key exclusion criteria (15 listed)
- A co-morbid condition which, in the view of the Investigator(s), rendered the patient at high risk from treatment complications
- Failed previous hematopoietic stem cell (HSC) collections or collection attempts
- Prior autologous or allogeneic transplant
- Less than 6 weeks off 1,3-bis (2-chloroethyl)-1-nitroso-urea (BCNU) prior to first dose of G-CSF
- Active central nervous system involvement, active brain metastases, or any history of carcinomatous meningitis (active or inactive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte-colony stimulating factor (G-CSF)Also: Filgrastim | Drug | Fixed Dose Plerixafor, Weight-Based Plerixafor |
| Fixed Dose PlerixaforAlso: Mozobil, AMD3100 | Drug | Fixed Dose Plerixafor |
| Weight-Based PlerixaforAlso: Mozobil, AMD3100 | Drug | Weight-Based Plerixafor |
Primary outcome
Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)
Time frame: Day 5 up to Day 8
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
8 secondary outcomes
Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis
Time frame: Day 5 up to Day 8
Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg
Time frame: Day 5 up to Day 8
Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg
Time frame: Day 5 up to Day 8
Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses
Time frame: Day 5 up to Day 8
Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor
Time frame: Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Terminal Elimination Half-life (T1/2)
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granulocyte-colony stimulating factor (G-CSF), Fixed Dose Plerixafor and Weight-Based Plerixafor in people with Non-Hodgkin's Lymphoma, run by Genzyme, a Sanofi Company at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, South Korea, Taiwan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) (time frame: Day 5 up to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.