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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02238873
• Date of registration: 08/09/2014
• Prospective Registration: Yes
• Primary sponsor: Rabin Medical Center
• Public title: Pegfilgrastim on Day +3 Compared to Day +1 After Salvage Chemotherapy for Patients With Refractory or Relapsed Aggressive Lymphoma
• Scientific title: Pegfilgrastim on Day +3 Compared to Day +1 for Patients With Refractory or Relapsed Aggressive Lymphoma Receiving Salvage Chemotherapy - a Randomized Controlled Trial
• Date of first enrolment: October 2014
• Target sample size: 300
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02238873
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Israel

Contacts

• Name: Liat Vidal, MD

• Name: Liat Vidal-Fisher, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma

Neutropenia

Intervention(s)

Drug: Pegfilgrastim

Primary Outcome(s)

Neutrophil count <500/ mcL [Time Frame: day 8 to 10]

Febrile neutropenia [Time Frame: 30 days]

Secondary Outcome(s)

Mortality [Time Frame: 30 days]

Neutrophil count <100/ mcL [Time Frame: day 8 to 10]

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]

Hospitalization [Time Frame: 30 days]

Adverse events [Time Frame: 30 days]

Number of febrile days [Time Frame: 30 days]

Secondary ID(s)

PEGFIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Soroka Medical Center

Tel-Aviv Sourasky Medical Center