Clinical trial NCT01408043: Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
Official title: A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Collection Using Plerixafor, Etoposide, and Filgrastim
timeFrame: Within 2 days of apheresis
measure: Progression-free Survival
timeFrame: Up to 1 year post-transplant
measure: Overall Survival
timeFrame: Up to 1 year post-transplant
Secondary outcomes:
measure: Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
timeFrame: Up to 28 days post treatment
measure: Platelet Recovery in Super Mobilizers and Normal Mobilizers
timeFrame: Up to 28 days post treatment
measure: Length of Hospital Stay in Super Mobilizers and Normal Mobilizers
timeFrame: Up to 28 days post treatment
measure: Progression-free Survival in Supermobilizers and Normal Mobilizers
timeFrame: Up to 1 year post-transplant
measure: Overall Survival in Supermobilizers and Normal Mobilizers
timeFrame: Up to 1 year post-transplant
measure: Number of Days of Apheresis Required
timeFrame: Up to 28 days post treatment
measure: Number of Transfusion Requirements
timeFrame: Up to 28 days post treatment
measure: Need for Remobilization
timeFrame: Up to 28 days post treatment
measure: Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells
timeFrame: Up to 28 days post treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Navneet Majhail, MD
role: PRINCIPAL_INVESTIGATOR
References: