Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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
Intervention: filgrastim (Biological); plerixafor (Drug); rituximab (Biological); ifosfamide (Drug); carboplatin (Drug); etoposide (Drug); leukapheresis (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s): Leona Holmberg, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Summary
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and
etoposide (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.
Clinical Details
Official title: Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ability to mobilize an adequate number of autologous PBSC
Secondary outcome: Toxicity assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0Engraftment after transplant as assessed by initial neutrophil recovery Delayed platelet engraftment after transplant Secondary graft failure Tumor status
Detailed description:
OBJECTIVES:
I. Determine the number of days of apheresis required to reach >= 5 x 10^6 CD34 cells/kg.
II. Determine 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 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of CD20+ non-Hodgkin's lymphoma
- Cardiac: left ventricular ejection fraction at rest >= 50% demonstrated by multi
gated acquisition scan (MUGA) or echocardiogram
- Hepatic: bilirubin =< 2. 0 mg/dL (except for isolated hyperbilirubinemia attributed to
Gilbert syndrome) and alanine aminotransferase (ALT) and aspartate aminotransferase
(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 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
Locations and Contacts
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States
Additional Information
Starting date: July 2010
Last updated: September 24, 2014
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