Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title:

A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01408043
• Other study ID #: CASE2410
• Secondary ID: NCI-2011-01281CA
• Status: Terminated
• Phase: N/A
• Start date: October 2011
• Est. completion date: May 2016

Study information

• Verified date: May 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 at 28 days and then for at least 1 year.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Have biopsy-confirmed non-Hodgkin lymphoma, of any type

• 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

• Negative for human immunodeficiency virus (HIV)

• prior to the start of mobilization, subjects must have:

• 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 and for at least 3 months following last plerixafor dose; 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 previous radiation of the pelvic area

• Have had prior radioimmunotherapy

• Have received experimental therapy within 2 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

Related Conditions & MeSH terms

• Adult Acute Lymphoblastic Leukemia in Remission
• Adult Grade III Lymphomatoid Granulomatosis
• Adult Nasal Type Extranodal NK/T-cell Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Burkitt Lymphoma
• Cutaneous B-cell Non-Hodgkin Lymphoma
• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Hepatosplenic T-cell Lymphoma
• Leukemia
• Leukemia, Hairy Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Large-Cell, Immunoblastic
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Lymphomatoid Granulomatosis
• Mycoses
• Mycosis Fungoides
• Nodal Marginal Zone B-cell Lymphoma
• Noncutaneous Extranodal Lymphoma
• Peripheral T-cell Lymphoma
• Plasmablastic Lymphoma
• Precursor Cell Lymphoblastic Leukemia-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 Chronic Lymphocytic Leukemia
• Refractory Hairy Cell Leukemia
• Sezary Syndrome
• Small Intestine Lymphoma
• Splenic Marginal Zone Lymphoma
• T-cell Large Granular Lymphocyte Leukemia
• Testicular Lymphoma
• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Drug:
• plerixafor
Given SC

Biological:
• filgrastim
Given SC

Drug:
• etoposide
Given IV

Procedure:
• leukapheresis
Undergo apheresis

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection Using Plerixafor, Etoposide, and Filgrastim	Number of participants able to collect equal to or more than 8 x 10^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10^6 CD34+ cells/kg are defined as normal mobilizers.	Within 2 days of apheresis
Primary	Progression-free Survival	The number of participants of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year	Up to 1 year post-transplant
Primary	Overall Survival	Number of participants who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant	Up to 1 year post-transplant
Secondary	Neutrophil Recovery in Super Mobilizers and Normal Mobilizers	Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers.	Up to 28 days post treatment
Secondary	Platelet Recovery in Super Mobilizers and Normal Mobilizers	Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg.	Up to 28 days post treatment
Secondary	Length of Hospital Stay in Super Mobilizers and Normal Mobilizers	Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg.	Up to 28 days post treatment
Secondary	Progression-free Survival in Supermobilizers and Normal Mobilizers	Percentage of participants who were alive and free of progression 1 year after transplant (PFS)	Up to 1 year post-transplant
Secondary	Overall Survival in Supermobilizers and Normal Mobilizers	Percentage of participants who were alive 1 year after transplant (OS)	Up to 1 year post-transplant
Secondary	Number of Days of Apheresis Required	Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers	Up to 28 days post treatment
Secondary	Number of Transfusion Requirements	Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers	Up to 28 days post treatment
Secondary	Need for Remobilization	Number of participants that needed remobilization in supermobilizers and normal mobilizers.; Remobilization can be described as follows: The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as "mobilization failure". For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal.	Up to 28 days post treatment
Secondary	Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells	Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.	Up to 28 days post treatment