Non-Hodgkin LymphomaPhase 2NCT01097057
Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
A Phase 2 study testing Carboplatin, Etoposide and Filgrastim in people with Non-Hodgkin Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Carboplatin, Etoposide and Filgrastim
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2010to 26 Dec 2017
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CD20+ non-Hodgkin's lymphoma
- Left ventricular ejection fraction at rest >= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
- Bilirubin =< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 times the upper limit of normal
- Creatinine clearance (calculated creatinine clearance is permitted) > 50 mL/min
- Signed informed consent
- Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)
Who cannot join
- Karnofsky performance score < 70%
- Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
- Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent > 5 years previously will be allowed
- Pregnant or breastfeeding
- Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
- Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)
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- Human immunodeficiency virus (HIV) positive
- Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
- Hepatitis B carriers
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.
Read the detailed description
OBJECTIVES:
- Evaluate the efficacy of combining RICE (rituximab-ifosfamide-carboplatin-etoposide regimen [R-ICE regimen]), G-CSF, and plerixafor to collect autologous peripheral blood stem cell (PBSC) for non-Hodgkin's lymphoma (NHL) patients by: the number of days of apheresis required to reach >= 5 x 10^6 cluster of differentiation (CD)34 cells/kg and by the total number of CD34 cells/kg collected in a maximum of 4 days if >= 5 x 10^6 CD34 cells/kg is not obtained.
OUTLINE:
Patients receive rituximab intravenously (IV) on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive filgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
After completion of study treatment, patients are followed up at 30 days and then periodically for up to 12 months.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Carboplatin, Etoposide, Filgrastim, Ifosfamide, Leukapheresis
- 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.
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar
Given IV
FilgrastimBiological
Also called Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSF
Given SC
IfosfamideDrug
Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan
Given IV
LeukapheresisProcedure or surgery
Also called Leukocytopheresis, Therapeutic Leukopheresis
Given through catheter
PlerixaforDrug
Also called AMD 3100, JM-3100, Mozobil, SDZ SID 791
Given SC
RituximabBiological
Also called BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, IDEC-102
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (rituximab, etoposide, carboplatin, ifosfamide) | Experimental | Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected. Receives: Drug: Carboplatin; Drug: Etoposide; Biological: Filgrastim; Drug: Ifosfamide; Procedure: Leukapheresis; Drug: Plerixafor; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)
Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis.
Measured: One Month
Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days
Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures.
Measured: Up to Four Apheresis Days
Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
Number of participants requiring one or two apheresis collection days to reach collection goal.
Measured: Up to Four Apheresis Days
Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days
Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days
Measured: Up to Four Apheresis Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study start9 Nov 2010
- Primary completionSep 2013
- Study completion26 Dec 2017
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 LymphomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Leona Holmberg, Fred Hutchinson Cancer Center
- Investigators
- Leona Holmberg, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097057
- Sponsor's protocol ID
- 2310.00
- Other IDs
- NCI-2009-01562, 2310.00, P30CA015704
- Status last verified
- Dec 2017
- First submitted
- 30 Mar 2010
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor
- ClinicalTrials.gov ID
- NCT01097057
- Acronym / sponsor ID
- 2310.00
- Conditions
- Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Nov 2010 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- 26 Dec 2017 (actual)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.
Detailed description
OBJECTIVES:
- Evaluate the efficacy of combining RICE (rituximab-ifosfamide-carboplatin-etoposide regimen [R-ICE regimen]), G-CSF, and plerixafor to collect autologous peripheral blood stem cell (PBSC) for non-Hodgkin's lymphoma (NHL) patients by: the number of days of apheresis required to reach >= 5 x 10^6 cluster of differentiation (CD)34 cells/kg and by the total number of CD34 cells/kg collected in a maximum of 4 days if >= 5 x 10^6 CD34 cells/kg is not obtained.
OUTLINE:
Patients receive rituximab intravenously (IV) on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive filgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
After completion of study treatment, patients are followed up at 30 days and then periodically for up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (rituximab, etoposide, carboplatin, ifosfamide) | Experimental | Drug: Carboplatin, Drug: Etoposide, Biological: Filgrastim, Drug: Ifosfamide, Procedure: Leukapheresis, Drug: Plerixafor, Biological: RituximabPatients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of CD20+ non-Hodgkin's lymphoma
- Left ventricular ejection fraction at rest >= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
- Bilirubin =< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 times the upper limit of normal
- Creatinine clearance (calculated creatinine clearance is permitted) > 50 mL/min
Key exclusion criteria (9 listed)
- Karnofsky performance score < 70%
- Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
- Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent > 5 years previously will be allowed
- Pregnant or breastfeeding
- Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
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 |
|---|---|---|
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Treatment (rituximab, etoposide, carboplatin, ifosfamide) |
| EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, ToposarGiven IV | Drug | Treatment (rituximab, etoposide, carboplatin, ifosfamide) |
| FilgrastimAlso: Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSFGiven SC | Biological | Treatment (rituximab, etoposide, carboplatin, ifosfamide) |
| IfosfamideAlso: Asta Z 4942, Asta Z-4942, Cyfos, HoloxanGiven IV | Drug | Treatment (rituximab, etoposide, carboplatin, ifosfamide) |
| LeukapheresisAlso: Leukocytopheresis, Therapeutic LeukopheresisGiven through catheter | Procedure or surgery | Treatment (rituximab, etoposide, carboplatin, ifosfamide) |
| PlerixaforAlso: AMD 3100, JM-3100, Mozobil, SDZ SID 791Given SC | Drug | Treatment (rituximab, etoposide, carboplatin, ifosfamide) |
| RituximabAlso: BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, IDEC-102Given IV | Biological | Treatment (rituximab, etoposide, carboplatin, ifosfamide) |
Primary outcome
Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)
Time frame: One Month
Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis.
Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days
Time frame: Up to Four Apheresis Days
Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures.
Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
Time frame: Up to Four Apheresis Days
Number of participants requiring one or two apheresis collection days to reach collection goal.
Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days
Time frame: Up to Four Apheresis Days
Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Leona Holmberg principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Etoposide and Filgrastim in people with Non-Hodgkin Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
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 7 inclusion and 9 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Jul 2017). 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?
Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) (time frame: One Month). The study lists 4 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 23 Jan 2018.