Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
This study is currently recruiting participants.
Verified April 2013 by Case Comprehensive Cancer Center
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01408043
First received: August 1, 2011
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
| Condition | Intervention |
|---|---|
|
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 |
Drug: plerixafor Biological: filgrastim Drug: etoposide Procedure: leukapheresis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma |
Resource links provided by NLM:
Drug Information available for:
Etoposide
Plerixafor
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Improvement of collection of greater than or equal to 8 x 10^6 CD34+ cells/kg by 25% using plerixafor, etoposide, and filgrastim [ Time Frame: Within 2 days of apheresis ] [ Designated as safety issue: No ]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.
- Improvement of progression-free survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Post-transplantation for at least 1 year ] [ Designated as safety issue: No ]Relative to 57% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 20% relative to the historical estimate of 57% would require 45 patients to achieve 5% significance with 80% power.
- Improvement of survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Post-transplantation for at least 1 year ] [ Designated as safety issue: No ]Relative to 68% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 15% relative to the historical estimate of 68% would require 44 patients to achieve 5% significance with 80% power.
Secondary Outcome Measures:
- Comparison of neutrophil recovery, platelet recovery, and length of hospital stay between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg [ Time Frame: Post-transplantation for 1 year ] [ Designated as safety issue: No ]Neutrophil recovery, platelet recovery, and length of hospital stay will be compared between patients receiving >8 x 106 CD34+ cells/kg and <8 x 106 CD34+ cells/kg using the Wilcoxon rank sum test.
- Comparison of overall survival and progression-free survival between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg [ Time Frame: Post-transplantation for at least 1 year ] [ Designated as safety issue: No ]
- Comparison of number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, and need for remobilization between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+cells/kg [ Time Frame: Post-transplantation for 1 year ] [ Designated as safety issue: No ]Days of apheresis required to achieve goal, transfusion requirements and hospitalization costs will be compared between patients receiving >8 and <8 x 106 CD34+ cells/kg using the Wilcoxon rank sum test; need for remobilization will be compared using the Chisquare test.
- Correlation of peripheral CD34+ cell count with graft content of CD34+ cells [ Time Frame: Within 2 days of apheresis ] [ Designated as safety issue: No ]The association between peripheral CD34+ cell count and graft content will be assessed using Spearman correlation.
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (stem cell supermobilization)
Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.
|
Drug: plerixafor
Given SC
Other Names:
Biological: filgrastim
Given SC
Other Names:
Drug: etoposide
Given IV
Other Names:
Procedure: leukapheresis
Undergo apheresis
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408043
Locations
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Hien K. Duong, MD 216-444-2529 duongh@ccf.org | |
| Principal Investigator: Hien K. Duong, MD | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Hien Duong, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01408043 History of Changes |
| Other Study ID Numbers: | CASE2410, NCI-2011-01281 |
| Study First Received: | August 1, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
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, Non-Hodgkin Lymphomatoid Granulomatosis Waldenstrom Macroglobulinemia Mycoses Mycosis Fungoides Sezary Syndrome |
Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse 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 Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 23, 2013