An interventional study of plerixafor and filgrastim in Adult Acute Lymphoblastic Leukemia in Remission, Adult Grade III Lymphomatoid Granulomatosis and Adult Nasal Type Extranodal NK/T-cell Lymphoma, sponsored by Case Comprehensive Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Treatment
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.
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.
prior to the start of mobilization, subjects must have:
Exclusion Criteria:
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 · Biological: filgrastim · Drug: etoposide · Procedure: leukapheresis
Given SC
Also known as: AMD 3100, Mozobil
Given SC
Also known as: G-CSF, Neupogen
Given IV
Also known as: EPEG, VP-16, VP-16-213
Undergo apheresis
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Treatment (Stem Cell Supermobilization) |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Withdrew: Unable to collect cells | 1 |
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.
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 7 |
| Normal Mobilizers | 17 |
| Non mobilizers | 1 |
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
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Progression-free Survival | 7 |
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
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Overall Survival | 7 |
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.
| K/ul | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 10.3 ± 0.5 |
| Normal Mobilizers | 10.2 ± 0.7 |
Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
| percentage of change | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 20.9 ± 6.5 |
| Normal Mobilizers | 19.8 ± 5.6 |
Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
| days | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 20.7 ± 0.5 |
| Normal Mobilizers | 22.5 ± 5.5 |
Percentage of participants who were alive and free of progression 1 year after transplant (PFS)
| percent of participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 100 |
| Normal Mobilizers | 82 |
Percentage of participants who were alive 1 year after transplant (OS)
| percent of participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 100 |
| Normal Mobilizers | 100 |
Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers
| days | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 1.1 ± 0.4 |
| Normal Mobilizers | 2.9 ± 1.1 |
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
| transfusions | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 3.7 ± 2.1 |
| Normal Mobilizers | 4.4 ± 2.0 |
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.
| Participants | Treatment (Stem Cell Supermobilization) |
|---|---|
| Supermobilizers | 0 |
| Normal Mobilizers | 0 |
Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.
No measurements were reported for this outcome.
Collected over Up to 1 year post-transplant. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Stem Cell Supermobilization) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Participants enrolled and received intervention.
| Age, Continuous(years) | Treatment (Stem Cell Supermobilization) |
|---|---|
| Mean | 62.48 ± 11.14 |
| Sex: Female, Male(Participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| Female | 4 |
| Male | 21 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 25 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Stem Cell Supermobilization) |
|---|---|
| United States | 25 |
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