NCT02238873

Brief Summary

Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells, specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim. Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. It has a much longer half-life than the parent filgrastim. It is removed from the body within the neutrophils. According to the American Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is cleared before and after neutropenia. Comparative low quality studies suggest that deferring pegfilgrastim delivery until neutrophil counts start dropping may result in improved its efficacy. This was further tested in a few small randomized controlled trials (high quality studies, considered the "gold standard" of studies) in different settings (including first chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given 24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim schedule affects the risk of fever during neutropenia, neutrophil count, length of hospitalization, mortality, and safety.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3 lymphoma

Geographic Reach
1 country

1 active site

Status
unknown

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

September 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

October 2, 2014

Status Verified

October 1, 2014

Enrollment Period

3.3 years

First QC Date

September 8, 2014

Last Update Submit

October 1, 2014

Conditions

LymphomaNeutropenia

Keywords

lymphomaneutropeniapegfilgrastim

Outcome Measures

Primary Outcomes (2)

  • Febrile neutropenia

    Number of participants with fever and neutropenia

    30 days

  • Neutrophil count <500/ mcL

    Number of participants with neutrophil count below 500 /mcL

    day 8 to 10

Secondary Outcomes (6)

  • Mortality

    30 days

  • Neutrophil count <100/ mcL

    day 8 to 10

  • Number of febrile days

    30 days

  • Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization

    30 days

  • Hospitalization

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Pegfilgrastim +1

ACTIVE COMPARATOR

Pegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy

Drug: Pegfilgrastim

Pegfilgrastim +3

EXPERIMENTAL

Pegfilgrastim will be given 72 hours (day +3) after completion of salvage chemotherapy

Drug: Pegfilgrastim

Interventions

PegfilgrastimDRUG
Also known as: Neulastim
Pegfilgrastim +1Pegfilgrastim +3

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age 18 years or above)
  • Refractory or relapsed aggressive lymphoma, including Hodgkin's and non-Hodgkin's lymphoma
  • Candidate for salvage chemotherapy. Salvage chemotherapy includes one of the following regimens: Ifosfamide, etoposide, vincristine (ICE), Cisplatin, cytarabine, and dexamethasone (DHAP), Etoposide, methylprednisolone, cytarabine, cisplatin (ESHAP). Chemotherapy dose reduction will be allowed.
  • Chemotherapy with or without immunotherapy
  • Therapy in hospital or at the outpatient clinic

You may not qualify if:

  • Indolent lymphoma; we will exclude patients with transformed lymphoma.
  • Treatment with GCSFs for the primary disease (e.g. aplastic anemia, MDS).
  • Uncontrolled infection
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

LymphomaNeutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte Disorders

Central Study Contacts

Liat Vidal-Fisher, MD

CONTACT

972-50-4065313vidallit@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MSc

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 12, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2018

Last Updated

October 2, 2014

Record last verified: 2014-10

Locations

IL(1)