Overview

This trial is active, not recruiting.

Condition non-hodgkin lymphoma
Treatments carboplatin, etoposide, filgrastim, ifosfamide, leukapheresis, plerixafor, rituximab
Phase phase 2
Target CD20
Sponsor Fred Hutchinson Cancer Research Center
Collaborator National Cancer Institute (NCI)
Start date July 2010
End date September 2013
Trial size 37 participants
Trial identifier NCT01097057, 2310.00, NCI-2009-01562, P30CA015704

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
carboplatin Blastocarb
Given IV
etoposide Demethyl Epipodophyllotoxin Ethylidine Glucoside
Given IV
filgrastim Filgrastim XM02
Given SC
ifosfamide Asta Z 4942
Given IV
leukapheresis Leukocytopheresis
Given through catheter
plerixafor AMD 3100
Given SC
rituximab BI 695500
Given IV

Primary Outcomes

Measure
Ability to mobilize an adequate number of autologous PBSC
time frame: Up to 12 months

Secondary Outcomes

Measure
Delayed platelet engraftment after transplant
time frame: 100 days
Engraftment after transplant as assessed by initial neutrophil recovery
time frame: 30 days
Secondary graft failure
time frame: 12 months
Toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
time frame: Up to 30 days post-treatment
Tumor status
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor
Principal investigator Leona Holmberg
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Fred Hutchinson Cancer Research Center.