A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
18 Years
78 Years
Both
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell 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 Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin 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 Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenstrom Macroglobulinemia
Trial Information
A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
PRIMARY OBJECTIVES:
I. To determine whether the addition of plerixafor improves the proportion of patients with
lymphoma who collect >= 8 x 10^6 cluster of differentiation (CD)34+ cells/kg within two days
by 25% compared to the historical estimate of 42% with etoposide and G-CSF (filgrastim).
II. To determine whether patients achieving collection of >= 8 x 10^6 CD34+ cells/kg have a
15% one year survival advantage relative to the historical estimate of 68% among patients
mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and G-CSF.
SECONDARY OBJECTIVES:
I. To demonstrate that patients receiving >= 8 x 10^6 CD34+ cells/kg have more rapid
neutrophil and platelet recovery and earlier hospital discharge than those receiving < 8 x
10^6 CD 34+ cells/kg.
II. To compare overall survival and progression-free survival between patients receiving >=
8 x 10^6 CD34+ cells/kg and those receiving < 8 x 10^6 CD34+ cells/kg.
III. To compare number of days of apheresis required to achieve goal, transfusion
requirements, hospitalization costs, need for remobilization between groups.
IV. To evaluate whether peripheral CD34+ cell count correlates with graft content of CD34+
cells.
OUTLINE:
Patients receive etoposide intravenously (IV) over 4 hours on day 0, filgrastim
subcutaneously (SC) once daily (QD) beginning day 1, and plerixafor SC 15-18 hours prior to
apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg
receive another dose of plerixafor followed by apheresis. Following the second apheresis,
patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and
continue collection according to the attending physician.
After completion of study treatment, patients are followed up for at least 1 year.
Inclusion Criteria:
- Have biopsy-confirmed non-Hodgkin lymphoma, of any type
- Be in first or second complete or partial remission
- Must be eligible for autologous transplantation according to institutional guidelines
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Karnofsky performance status of 70 to 100
- >= 3 weeks since last cycle of chemotherapy
- Negative for human immunodeficiency virus (HIV)
- White blood cell count >= 2.5 x 10^9/L
- Absolute neutrophil count of >= 1.2 x 10^9/L
- Platelet count of >= 100 x 10^9/L
- Creatinine clearance >= 30 mL/minute
- All patients must be able to comprehend and sign informed consent
- If childbearing potential must either agree to complete abstinence from heterosexual
intercourse or effective means of contraception during stem cell mobilization; female
patients will undergo pregnancy test prior to stem cell mobilization therapy
Exclusion Criteria:
- Have had previous transplants and/or prior mobilization attempts
- Have evidence of progressive non-Hodgkin lymphoma
- Have evidence of bone marrow involvement of lymphoma at time of transplant staging
- Had evidence of active central nervous system (CNS) involvement
- Have had > 3 prior regimens for treatment of non-Hodgkin lymphoma
- Have had previous radiation of the pelvic area
- Have had prior radioimmunotherapy
- Have received G-CSF (filgrastim) or other growth factors within 14 days of the
etoposide dose
- Have received experimental therapy within 4 weeks of enrollment
- Be currently enrolled in another investigational protocol
- Have prior history of other malignancies, excluding basal cell carcinoma or squamous
cell carcinoma of the skin
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Improvement of collection of greater than or equal to 8 x 10^6 CD34+ cells/kg by 25% using plerixafor, etoposide, and filgrastim
Outcome Description:
Relative to 42% of patients who collected >= 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Twenty nine patients would be needed to demonstrate a 25% improvement to 67% based on a one-sided test with 5% significance and 80% power.
Outcome Time Frame:
Within 2 days of apheresis
Safety Issue:
No
Principal Investigator
Hien Duong, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE2410
NCT ID:
NCT01408043
Start Date:
October 2011
Completion Date:
Related Keywords:
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Noncutaneous Extranodal Lymphoma
- Peripheral T-cell 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 Adult T-cell Leukemia/Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin 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 Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Refractory Hairy Cell Leukemia
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- T-cell Large Granular Lymphocyte Leukemia
- Testicular Lymphoma
- Waldenström Macroglobulinemia
- Burkitt Lymphoma
- Immunoblastic Lymphadenopathy
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Hairy Cell
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphomatoid Granulomatosis
- Waldenstrom Macroglobulinemia
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Extranodal NK-T-Cell
- Lymphoma, Mantle-Cell
- Leukemia, Large Granular Lymphocytic
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
