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

Sponsor:	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT01097057

Purpose

RATIONALE: 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. 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.

Condition	Intervention	Phase
Adult Non-Hodgkin Lymphoma Adult Grade III Lymphomatoid Granulomatosis 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 Waldenstrom 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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Podofilox Ifosfamide Etoposide Carboplatin Plerixafor Etoposide phosphate Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor Rituximab

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Ability to mobilize an adequate number of autologous PBSC [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity assessed by NCI CTCAE v3.0 [ Time Frame: 3 years ] [ 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: Arm I 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 subcutaneously (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 subcutaneously Other Names: G-CSF granulocyte colony-stimulating factor Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor Drug: plerixafor Given subcutaneously Other Names: AMD 3100 LM-3100 Mozobil Biological: rituximab Given IV Other Names: C2B8 Monoclonal Antibody IDEC-C2B8 IDEC-C2B8 monoclonal antibody Mabthera MOAB IDEC-C2B8 Rituxan Drug: ifosfamide Given IV Other Names: Cyfos Holoxan Ifex IFF IFX IPP Drug: carboplatin Given IV Other Names: Carboplat CBDCA JM-8 Paraplat Paraplatin Paraplatine Drug: etoposide Given IV Other Names: Demethyl Epipodophyllotoxin Ethylidine Glucoside EPEG epipodophyllotoxin VePesid VP-16 VP-16-213 Procedure: leukapheresis Through catheter

Arms

Assigned Interventions

Experimental: Arm I

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 subcutaneously (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 subcutaneously

Other Names:

G-CSF
granulocyte colony-stimulating factor
Neupogen
r-metHuG-CSF
Recombinant Methionyl Human Granulocyte Colony Stimulating Factor

Drug: plerixafor

Given subcutaneously

Other Names:

AMD 3100
LM-3100
Mozobil

Biological: rituximab

Given IV

Other Names:

C2B8 Monoclonal Antibody
IDEC-C2B8
IDEC-C2B8 monoclonal antibody
Mabthera
MOAB IDEC-C2B8
Rituxan

Drug: ifosfamide

Given IV

Other Names:

Cyfos
Holoxan
Ifex
IFF
IFX
IPP

Drug: carboplatin

Given IV

Other Names:

Carboplat
CBDCA
JM-8
Paraplat
Paraplatin
Paraplatine

Drug: etoposide

Given IV

Other Names:

Demethyl Epipodophyllotoxin Ethylidine Glucoside
EPEG
epipodophyllotoxin
VePesid
VP-16
VP-16-213

Procedure: leukapheresis

Through catheter

Detailed Description:

OBJECTIVES: I. Determine the number of days of apheresis required to reach >= 5 x 106 CD34 cells/kg. II. Determine the number of CD34 cells/kg collected in a maximum of 7 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

Criteria

Inclusion Criteria:

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
Cardiac: left ventricular ejection fraction at rest >= 50% demonstrated by MUGA or echocardiogram
Renal: creatinine clearance (calculated creatinine clearance is permitted) > 50 mL/min
Signed informed consent
Planned autologous transplant within 3 months after collection of PBSCs
Diagnosis of CD20+ non-Hodgkin's lymphoma

Exclusion Criteria:

HIV positive
Karnofsky performance score < 70%
Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
Pregnant or breastfeeding
Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
Prior autologous or allogeneic HSCT
Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
Hepatitis B carriers
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
Other investigational agents during study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097057

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

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Leona Holmberg

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

More Information

No publications provided

Responsible Party:	Holmberg, Leona, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier:	NCT01097057 History of Changes
Other Study ID Numbers:	2310.00, NCI-2009-01562
Study First Received:	March 30, 2010
Last Updated:	February 6, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Burkitt Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphomatoid Granulomatosis
Waldenstrom Macroglobulinemia
Lymphoma, B-Cell
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 24, 2012