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

NCT ID: NCT00741325

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-11-30

Brief Summary

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).

Detailed 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).

Conditions

Non-Hodgkin's Lymphoma; Autologous Transplantation

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

G-CSF plus plerixafor

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

granulocyte colony-stimulating factor (G-CSF)

Intervention Type: DRUG

plerixafor

Intervention Type: DRUG

G-CSF plus placebo

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

granulocyte colony-stimulating factor (G-CSF)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

granulocyte colony-stimulating factor (G-CSF)

Intervention Type: DRUG

plerixafor

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Mozobil; AMD3100

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

References

Micallef IN, Stiff PJ, Nademanee AP, Maziarz RT, Horwitz ME, Stadtmauer EA, Kaufman JL, McCarty JM, Vargo R, Cheverton PD, Struijs M, Bolwell B, DiPersio JF. Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report. Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2.

Reference Type: DERIVED

PMID: 29410180 (View on PubMed)

Other Identifiers

AMD31003101LTF

Identifier Type: -

Identifier Source: org_study_id