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Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
This study is ongoing, but not recruiting participants.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leona Holmberg, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01097057
First received: March 30, 2010
Last updated: June 1, 2017
Last verified: June 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Non-Hodgkin Lymphoma | Drug: Carboplatin Drug: Etoposide Biological: Filgrastim Drug: Ifosfamide Procedure: Leukapheresis Drug: Plerixafor Biological: Rituximab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor |
Resource links provided by NLM:
Further study details as provided by Leona Holmberg, Fred Hutchinson Cancer Research Center:
Primary Outcome Measures:
- 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
| Enrollment: | 20 |
| Actual Study Start Date: | November 9, 2010 |
| Estimated Study Completion Date: | December 26, 2017 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (rituximab, etoposide, carboplatin, ifosfamide)
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.
|
Drug: Carboplatin
Given IV
Other Names:
Drug: Etoposide
Given IV
Other Names:
Biological: Filgrastim
Given SC
Other Names:
Drug: Ifosfamide
Given IV
Other Names:
Procedure: Leukapheresis
Given through catheter
Other Names:
Drug: Plerixafor
Given SC
Other Names:
Biological: Rituximab
Given IV
Other Names:
|
Detailed Description:
OBJECTIVES:
I. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
- Human immunodeficiency virus (HIV) positive
- Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
- Hepatitis B carriers
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01097057
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097057
Locations
| United States, Washington | |
| Fred Hutch/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Leona Holmberg | Fred Hutch/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Leona Holmberg, Principal Investigator, Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT01097057 History of Changes |
| Other Study ID Numbers: |
2310.00 NCI-2009-01562 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2310.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P30CA015704 ( U.S. NIH Grant/Contract ) |
| Study First Received: | March 30, 2010 |
| Results First Received: | March 26, 2017 |
| Last Updated: | June 1, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Etoposide phosphate Isophosphamide mustard Carboplatin Rituximab Etoposide Ifosfamide Podophyllotoxin |
Antibodies Immunoglobulins Antibodies, Monoclonal Lenograstim JM 3100 Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on August 21, 2017