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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02238873
• Other study ID #: PEGFIL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 8, 2014
• Last updated: October 1, 2014
• Start date: October 2014

Study information

• Verified date: October 2014
• Source: Rabin Medical Center
• Contact: Liat Vidal-Fisher, MD
• Phone: 972-50-4065313
• Email: vidallit[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphoma
• Neutropenia

Intervention

Drug:
• Pegfilgrastim

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Rabin Medical Center	Soroka Medical Center, Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Febrile neutropenia	Number of participants with fever and neutropenia	30 days	Yes
Primary	Neutrophil count <500/ mcL	Number of participants with neutrophil count below 500 /mcL	day 8 to 10	No
Secondary	Mortality	Number of participants who died by day 30	30 days	Yes
Secondary	Neutrophil count <100/ mcL	Number of patients with neutrophil count below 100/ mcL	day 8 to 10
Secondary	Number of febrile days	a febrile day defined by at least one documented temperature measurement >38ºC	30 days
Secondary	Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization	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	30 days
Secondary	Hospitalization	Number of hospitalization days of each participant (excluding days of hospitalization for chemotherapy)	30 days
Secondary	Adverse events	ECOG common toxicity criteria grading Number of patients with an adverse event (AE). Number of patients with grade 3-4 AE	30 days	Yes