Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

Genzyme

Status and phase

Completed

Phase 3

Conditions

Lymphoma, Non-Hodgkin

Treatments

Drug: Granulocyte colony-stimulating factor plus plerixafor

Drug: Granulocyte colony-stimulating factor plus placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00103610

AMD3100-3101

Details and patient eligibility

About

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.

Full description

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim is better than filgrastim alone in helping non-Hodgkin's lymphoma patients collect at least 5 million stem cells in four or less apheresis sessions.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Enrollment

298 patients

Sex

All

Ages

18 to 78 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Abbreviated List):

Non-Hodgkin's lymphoma in first or second complete or partial remission
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
White Blood Cell count (WBC) > 2.5*10^9/L
Platelet (PLT) > 100*10^9/L

Exclusion Criteria (Abbreviated List):

Failed previous stem cell collection
Prior autologous or allogeneic transplant
Brain metastases or bone marrow involvement > 20%
Radiation to pelvis
Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality