Long-Term Follow-up Study for Non-Hodgkin's Lymphoma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3101 Study (NCT00103610).

Genzyme

Status: Completed

Conditions: Non-Hodgkin's Lymphoma; Autologous Transplantation

Treatments: Drug: granulocyte colony-stimulating factor (G-CSF); Drug: plerixafor; Drug: Placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT00741325

AMD31003101LTF

Details and patient eligibility

About

This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).

Full description

This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled investigational study to evaluate granulocyte colony stimulating factor (G-CSF) plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkin's Lymphoma (NHL) patients (protocol AMD3100-3101 [NCT00103610]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610).

Enrollment: 178 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who received a dose of study treatment (plerixafor or placebo)in protocol AMD3100-3101 (NCT00103610)

Exclusion criteria

• No Exclusion Criteria

Trial design

178 participants in 2 patient groups

G-CSF plus plerixafor

Description:

Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received plerixafor, prior to undergoing apheresis.

Treatment:

Drug: plerixafor

Drug: granulocyte colony-stimulating factor (G-CSF)

G-CSF plus placebo

Description:

Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received placebo, prior to undergoing apheresis.

Treatment:

Drug: granulocyte colony-stimulating factor (G-CSF)

Drug: Placebo