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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

Testicular Lymphoma

Waldenström Macroglobulinemia

Study Interventions

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.

Drug:plerixaforGiven SC

Biological:filgrastimGiven SC

Drug:etoposideGiven IV

Procedure:leukapheresisUndergo apheresis

Study Arms

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.

Study Status

Terminated

Start Date: October 2011

Completed Date: May 2016

Phase: N/A

Type: Interventional

Design:

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)

More information:https://clinicaltrials.gov/show/NCT01408043

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