NCT01408043

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 14, 2019

Completed
Last Updated

June 14, 2019

Status Verified

May 1, 2019

Enrollment Period

4.6 years

First QC Date

August 1, 2011

Results QC Date

October 23, 2018

Last Update Submit

May 22, 2019

Conditions

Adult Acute Lymphoblastic Leukemia in RemissionAdult Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaCutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaNodal Marginal Zone B-cell LymphomaNoncutaneous Extranodal LymphomaPeripheral T-cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaSmall Intestine LymphomaSplenic Marginal Zone LymphomaT-cell Large Granular Lymphocyte LeukemiaTesticular LymphomaWaldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (3)

  • Collection Using Plerixafor, Etoposide, and Filgrastim

    Number of participants able to collect equal to or more than 8 x 10\^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10\^6 CD34+ cells/kg are defined as normal mobilizers.

    Within 2 days of apheresis

  • Progression-free Survival

    The number of participants of patients who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year

    Up to 1 year post-transplant

  • Overall Survival

    Number of participants who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant

    Up to 1 year post-transplant

Secondary Outcomes (9)

  • Neutrophil Recovery in Super Mobilizers and Normal Mobilizers

    Up to 28 days post treatment

  • Platelet Recovery in Super Mobilizers and Normal Mobilizers

    Up to 28 days post treatment

  • Length of Hospital Stay in Super Mobilizers and Normal Mobilizers

    Up to 28 days post treatment

  • Progression-free Survival in Supermobilizers and Normal Mobilizers

    Up to 1 year post-transplant

  • Overall Survival in Supermobilizers and Normal Mobilizers

    Up to 1 year post-transplant

  • +4 more secondary outcomes

Study Arms (1)

Treatment (stem cell supermobilization)

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.

Drug: plerixaforBiological: filgrastimDrug: etoposideProcedure: leukapheresis

Interventions

plerixaforDRUG

Given SC

Also known as: AMD 3100, Mozobil
Treatment (stem cell supermobilization)
filgrastimBIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen
Treatment (stem cell supermobilization)
etoposideDRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213
Treatment (stem cell supermobilization)
leukapheresisPROCEDURE

Undergo apheresis

Treatment (stem cell supermobilization)

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneLymphoma, T-Cell, PeripheralBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, Large Granular LymphocyticWaldenstrom Macroglobulinemia

Interventions

plerixaforFilgrastimGranulocyte Colony-Stimulating FactorEtoposideLeukapheresis

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCytapheresisBiological TherapyTherapeuticsBlood Component RemovalLeukocyte Reduction ProceduresCell SeparationCytological TechniquesClinical Laboratory TechniquesInvestigative Techniques

Results Point of Contact

Title
Navneet Majhail
Organization
Case Comprehensive Cancer Center
majhain@ccf.org
216-444-2199

Study Officials

  • Navneet Majhail, MD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 14, 2019

Results First Posted

June 14, 2019

Record last verified: 2019-05

Locations

US(1)