Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
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Purpose
This phase II trial is studying how well giving rituximab, ICE combination chemotherapy, and 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 filgrastim (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 |
|---|---|---|
|
Adult Grade III Lymphomatoid Granulomatosis Adult Non-Hodgkin Lymphoma Contiguous Stage II Adult Burkitt Lymphoma Contiguous Stage II Adult Diffuse Large Cell Lymphoma Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma Contiguous Stage II Adult Lymphoblastic Lymphoma Contiguous Stage II Grade 1 Follicular Lymphoma Contiguous Stage II Grade 2 Follicular Lymphoma Contiguous Stage II Grade 3 Follicular Lymphoma Contiguous Stage II Mantle Cell Lymphoma Contiguous Stage II Marginal Zone Lymphoma Contiguous Stage II Small Lymphocytic Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Marginal Zone Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Primary Central Nervous System Non-Hodgkin Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma Stage I Adult Burkitt Lymphoma Stage I Adult Diffuse Large Cell Lymphoma Stage I Adult Diffuse Mixed Cell Lymphoma Stage I Adult Diffuse Small Cleaved Cell Lymphoma Stage I Adult Immunoblastic Large Cell Lymphoma Stage I Adult Lymphoblastic Lymphoma Stage I Grade 1 Follicular Lymphoma Stage I Grade 2 Follicular Lymphoma Stage I Grade 3 Follicular Lymphoma Stage I Mantle Cell Lymphoma Stage I Marginal Zone Lymphoma Stage I Small Lymphocytic Lymphoma Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Mixed Cell Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Small Lymphocytic Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Small Lymphocytic Lymphoma Waldenström Macroglobulinemia |
Biological: filgrastim Drug: plerixafor Biological: rituximab Drug: ifosfamide Drug: carboplatin Drug: etoposide Procedure: leukapheresis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Ability to mobilize an adequate number of autologous PBSC [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Toxicity assessed by NCI CTCAE v3.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
- Engraftment after transplant as assessed by initial neutrophil recovery [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Delayed platelet engraftment after transplant [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- Secondary graft failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Tumor status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | March 2016 (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, and carboplatin and ifosfamide IV on day 3. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 7 apheresis procedures until the optimal number of CD34+ cells are collected.
|
Biological: filgrastim
Given SC
Other Names:
Drug: plerixafor
Given SC
Other Names:
Biological: rituximab
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Procedure: leukapheresis
Given through catheter
|
Detailed Description:
OBJECTIVES:
I. Determine the number of days of apheresis required to reach >= 5 x 10^6 CD34 cells/kg.
II. Determine the 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 IV on day 1, etoposide IV on days 2-4, and carboplatin and ifosfamide IV on day 3. Patients also receive filgrastim (G-CSF) 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 periodically for up to 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of CD20+ non-Hodgkin's lymphoma
- Cardiac: left ventricular ejection fraction at rest >= 50% demonstrated by MUGA or echocardiogram
- Hepatic: bilirubin =< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) and ALT and AST =< 3 times the upper limit of normal
- Renal: creatinine clearance (calculated creatinine clearance is permitted) > 50 mL/min
- Signed informed consent
- Planned autologous transplant within 3 months after collection of 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 HSCT
- HIV positive
- Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
- Hepatitis B carriers
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Leona A. Holmberg 206-667-6447 | |
| Principal Investigator: Leona A. Holmberg | |
| Principal Investigator: | Leona Holmberg | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01097057 History of Changes |
| Other Study ID Numbers: | 2310.00, NCI-2009-01562 |
| Study First Received: | March 30, 2010 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma, Non-Hodgkin Burkitt Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Lymphoma, Follicular Lymphomatoid Granulomatosis Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Mantle-Cell Epstein-Barr Virus Infections |
Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Neoplasms by Histologic Type Neoplasms Neoplasms, Experimental Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia Precancerous Conditions |
ClinicalTrials.gov processed this record on May 16, 2013