Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Cutaneous B-cell Non-Hodgkin Lymphoma; T-cell Large Granular Lymphocyte Leukemia; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Splenic Marginal Zone Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Anaplastic Large Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Diffuse Mixed Cell Lymphoma; Small Intestine Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Testicular Lymphoma; Recurrent Mantle Cell Lymphoma; Refractory Chronic Lymphocytic Leukemia; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Angioimmunoblastic T-cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Noncutaneous Extranodal Lymphoma; Waldenström Macroglobulinemia; Recurrent Small Lymphocytic Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Adult Acute Lymphoblastic Leukemia in Remission; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Hepatosplenic T-cell Lymphoma; Adult Nasal Type Extranodal NK/T-cell Lymphoma; Refractory Hairy Cell Leukemia; Recurrent Adult T-cell Leukemia/Lymphoma; Peripheral T-cell Lymphoma

Treatments: Drug: plerixafor; Procedure: leukapheresis; Drug: etoposide; Biological: filgrastim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01408043

CASE2410 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

NCI-2011-01281 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment (stem cell supermobilization)

Experimental group

Description:

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.

Treatment:

Procedure: leukapheresis

Biological: filgrastim

Drug: etoposide

Drug: plerixafor