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Pegfilgrastim on Day +3 Compared to Day +1 After Salvage Chemotherapy for Patients With Refractory or Relapsed Aggressive Lymphoma

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ClinicalTrials.gov Identifier: NCT02238873
Recruitment Status : Unknown
Verified October 2014 by LIAT VIDAL FISHER, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2014
Last Update Posted : October 2, 2014
Sponsor:
Collaborators:
Tel-Aviv Sourasky Medical Center
Soroka University Medical Center
Information provided by (Responsible Party):
LIAT VIDAL FISHER, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Lymphoma Neutropenia Drug: Pegfilgrastim Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pegfilgrastim on Day +3 Compared to Day +1 for Patients With Refractory or Relapsed Aggressive Lymphoma Receiving Salvage Chemotherapy - a Randomized Controlled Trial
Study Start Date : October 2014
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Active Comparator: Pegfilgrastim +1
Pegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy
Drug: Pegfilgrastim
Other Name: Neulastim

Experimental: Pegfilgrastim +3
Pegfilgrastim will be given 72 hours (day +3) after completion of salvage chemotherapy
Drug: Pegfilgrastim
Other Name: Neulastim




Primary Outcome Measures :
  1. Febrile neutropenia [ Time Frame: 30 days ]
    Number of participants with fever and neutropenia

  2. Neutrophil count <500/ mcL [ Time Frame: day 8 to 10 ]
    Number of participants with neutrophil count below 500 /mcL


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Number of participants who died by day 30

  2. Neutrophil count <100/ mcL [ Time Frame: day 8 to 10 ]
    Number of patients with neutrophil count below 100/ mcL

  3. Number of febrile days [ Time Frame: 30 days ]
    a febrile day defined by at least one documented temperature measurement >38ºC

  4. Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization [ Time Frame: 30 days ]
    Number of participants with CDI, MCI or BSI. CDI, MDI and BSI will be defined in accordance with the CDC surveillance definitions for healthcare-associated infections

  5. Hospitalization [ Time Frame: 30 days ]
    Number of hospitalization days of each participant (excluding days of hospitalization for chemotherapy)

  6. Adverse events [ Time Frame: 30 days ]
    ECOG common toxicity criteria grading Number of patients with an adverse event (AE). Number of patients with grade 3-4 AE



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238873


Contacts
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Contact: Liat Vidal-Fisher, MD 972-50-4065313 vidallit@yahoo.com

Locations
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Israel
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Liat Vidal, MD    972-50-4065313    vidallit@yahoo.com   
Sponsors and Collaborators
Rabin Medical Center
Tel-Aviv Sourasky Medical Center
Soroka University Medical Center

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Responsible Party: LIAT VIDAL FISHER, MD MSc, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02238873     History of Changes
Other Study ID Numbers: PEGFIL
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014
Keywords provided by LIAT VIDAL FISHER, Rabin Medical Center:
lymphoma
neutropenia
pegfilgrastim
Additional relevant MeSH terms:
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Lymphoma
Neutropenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases