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An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)

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Roche

Status and phase

Completed
Phase 4

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Chemotherapy
Drug: Pegfilgrastim
Drug: Immunochemotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT02782845
ML19812

Details and patient eligibility

About

This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.

Enrollment

53 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • NHL supported by an Immunohistochemical report
  • Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (>/=) 2
  • Total serum bilirubin less than (<) 2 times upper limit of normal (ULN)
  • Absolute neutrophil count (ANC) greater than (>) 2 x10^9 per liter (/L)

Exclusion criteria

  • Bone marrow compromised > 10 percent (%)
  • Any malignant myeloid condition
  • Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation
  • Known hypersensitivity reactions to Escherichia coli derived products
  • Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

Pegfilgrastim
Experimental group
Description:
Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care.
Treatment:
Drug: Pegfilgrastim
Drug: Immunochemotherapy
Drug: Chemotherapy

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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