Adult Acute Lymphoblastic Leukemia in Remission | Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
Adult Acute Lymphoblastic Leukemia in Remission research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
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
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
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.
Start Date: October 2011
Completed Date: May 2016
Primary Outcome: Collection Using Plerixafor, Etoposide, and Filgrastim
Secondary Outcome: Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
Study sponsors, principal investigator, and references
Principal Investigator: Navneet Majhail, MD
Lead Sponsor: Case Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)