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, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell 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 Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia
Conditions
Brief 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.
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 at 28 days and then for at least 1 year.
Interventions
Given SC
Given SC
Given IV
Undergo apheresis
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection Using Plerixafor, Etoposide, and Filgrastim | Within 2 days of apheresis | 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. |
| Progression-free Survival | Up to 1 year post-transplant | 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 |
| Overall Survival | Up to 1 year post-transplant | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival in Supermobilizers and Normal Mobilizers | Up to 1 year post-transplant | Percentage of participants who were alive and free of progression 1 year after transplant (PFS) |
| Overall Survival in Supermobilizers and Normal Mobilizers | Up to 1 year post-transplant | Percentage of participants who were alive 1 year after transplant (OS) |
| Number of Days of Apheresis Required | Up to 28 days post treatment | Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers |
| Neutrophil Recovery in Super Mobilizers and Normal Mobilizers | Up to 28 days post treatment | 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. |
| Need for Remobilization | Up to 28 days post treatment | 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. |
| Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells | Up to 28 days post treatment | Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation. |
| Number of Transfusion Requirements | Up to 28 days post treatment | 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 |
| Platelet Recovery in Super Mobilizers and Normal Mobilizers | Up to 28 days post treatment | Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg. |
| Length of Hospital Stay in Super Mobilizers and Normal Mobilizers | Up to 28 days post treatment | Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
plerixafor: Given SC
filgrastim: Given SC
etoposide: Given IV
leukapheresis: Undergo apheresis | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | unable to collect cells | 1 |
Baseline characteristics
| Characteristic | Treatment (Stem Cell Supermobilization) |
|---|---|
| Age, Continuous | 62.48 years STANDARD_DEVIATION 11.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: Within 2 days of apheresis
Population: All participants that went on study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Collection Using Plerixafor, Etoposide, and Filgrastim | Non mobilizers | 1 Participants |
| Treatment (Stem Cell Supermobilization) | Collection Using Plerixafor, Etoposide, and Filgrastim | Supermobilizers | 7 Participants |
| Treatment (Stem Cell Supermobilization) | Collection Using Plerixafor, Etoposide, and Filgrastim | Normal Mobilizers | 17 Participants |
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
Time frame: Up to 1 year post-transplant
Population: Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Stem Cell Supermobilization) | Overall Survival | 7 Participants |
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
Time frame: Up to 1 year post-transplant
Population: Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Stem Cell Supermobilization) | Progression-free Survival | 7 Participants |
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.
Time frame: Up to 28 days post treatment
Population: No data collected for this outcome due to low accrual
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.
Time frame: Up to 28 days post treatment
Population: All participants that had some mobilization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Length of Hospital Stay in Super Mobilizers and Normal Mobilizers | Supermobilizers | 20.7 days | Standard Deviation 0.5 |
| Treatment (Stem Cell Supermobilization) | Length of Hospital Stay in Super Mobilizers and Normal Mobilizers | Normal Mobilizers | 22.5 days | Standard Deviation 5.5 |
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.
Time frame: Up to 28 days post treatment
Population: Participants that were mobilized
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Need for Remobilization | Supermobilizers | 0 Participants |
| Treatment (Stem Cell Supermobilization) | Need for Remobilization | Normal Mobilizers | 0 Participants |
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.
Time frame: Up to 28 days post treatment
Population: All participants that had some mobilization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Neutrophil Recovery in Super Mobilizers and Normal Mobilizers | Supermobilizers | 10.3 K/ul | Standard Deviation 0.5 |
| Treatment (Stem Cell Supermobilization) | Neutrophil Recovery in Super Mobilizers and Normal Mobilizers | Normal Mobilizers | 10.2 K/ul | Standard Deviation 0.7 |
Number of Days of Apheresis Required
Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers
Time frame: Up to 28 days post treatment
Population: Participants that were mobilized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Number of Days of Apheresis Required | Supermobilizers | 1.1 days | Standard Deviation 0.4 |
| Treatment (Stem Cell Supermobilization) | Number of Days of Apheresis Required | Normal Mobilizers | 2.9 days | Standard Deviation 1.1 |
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
Time frame: Up to 28 days post treatment
Population: Participants that were mobilized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Number of Transfusion Requirements | Supermobilizers | 3.7 transfusions | Standard Deviation 2.1 |
| Treatment (Stem Cell Supermobilization) | Number of Transfusion Requirements | Normal Mobilizers | 4.4 transfusions | Standard Deviation 2 |
Overall Survival in Supermobilizers and Normal Mobilizers
Percentage of participants who were alive 1 year after transplant (OS)
Time frame: Up to 1 year post-transplant
Population: All participants that had some mobilization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Overall Survival in Supermobilizers and Normal Mobilizers | Normal Mobilizers | 100 percent of participants |
| Treatment (Stem Cell Supermobilization) | Overall Survival in Supermobilizers and Normal Mobilizers | Supermobilizers | 100 percent of participants |
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.
Time frame: Up to 28 days post treatment
Population: All participants that had some mobilization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Platelet Recovery in Super Mobilizers and Normal Mobilizers | Supermobilizers | 20.9 percentage of change | Standard Deviation 6.5 |
| Treatment (Stem Cell Supermobilization) | Platelet Recovery in Super Mobilizers and Normal Mobilizers | Normal Mobilizers | 19.8 percentage of change | Standard Deviation 5.6 |
Progression-free Survival in Supermobilizers and Normal Mobilizers
Percentage of participants who were alive and free of progression 1 year after transplant (PFS)
Time frame: Up to 1 year post-transplant
Population: All participants that had some mobilization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | Progression-free Survival in Supermobilizers and Normal Mobilizers | Supermobilizers | 100 percent of participants |
| Treatment (Stem Cell Supermobilization) | Progression-free Survival in Supermobilizers and Normal Mobilizers | Normal Mobilizers | 82 percent of participants |