Overview

This trial has been terminated.

Conditions 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
Treatments plerixafor, filgrastim, etoposide, leukapheresis
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date October 2011
End date May 2016
Trial size 25 participants
Trial identifier NCT01408043, CASE2410, NCI-2011-01281, P30CA043703

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 AMD 3100
Given SC
filgrastim G-CSF
Given SC
etoposide EPEG
Given IV
leukapheresis
Undergo apheresis

Primary Outcomes

Measure
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
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: Up to 1 year post-transplant
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: Up to 1 year post-transplant

Secondary Outcomes

Measure
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: Up to 28 days post treatment
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: Up to 1 year post-transplant
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: Up to 28 days post treatment
Correlation of peripheral CD34+ cell count with graft content of CD34+ cells
time frame: Up to 28 days post treatment

Eligibility Criteria

Male or female participants from 18 years up to 78 years old.

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

Additional Information

Official title A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
Principal investigator Hien Liu
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.