Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells

Non-Hodgkin Lymphoma Clinical Trial

Official title:

Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097057
• Other study ID #: 2310.00
• Secondary ID: NCI-2009-0156223
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2010
• Last updated: December 28, 2017
• Start date: November 9, 2010
• Est. completion date: December 26, 2017

Study information

• Verified date: December 2017
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 26, 2017
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• Carboplatin
Given IV
• Etoposide
Given IV

Biological:
• Filgrastim
Given SC

Drug:
• Ifosfamide
Given IV

Procedure:
• Leukapheresis
Given through catheter

Drug:
• Plerixafor
Given SC

Biological:
• Rituximab
Given IV

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One Month
Primary	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.	Up to Four Apheresis Days
Primary	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.	Up to Four Apheresis Days
Primary	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	Up to Four Apheresis Days