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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 5 * 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation


Phase 3
18 Years
78 Years
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 5 * 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis

Outcome Description:

Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Outcome Time Frame:

Days 5 to 8

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD3100-3101

NCT ID:

NCT00103610

Start Date:

January 2005

Completion Date:

December 2007

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Non-Hodgkin's lymphoma
  • Stem cell mobilization
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Loyola University Medical CenterMaywood, Illinois  60153
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Rochester Medical CenterRochester, New York  14642
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Rocky Mountain Cancer CenterDenver, Colorado  80218
City of Hope National Medical CenterLos Angeles, California  91010
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of MinnesotaMinneapolis, Minnesota  55455
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Case Western Reserve UniversityCleveland, Ohio  44106
University of Texas Health Science CenterSan Antonio, Texas  78284
Texas Transplant InstituteSan Antonio, Texas  78229
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Virginia Commonwealth UniversityRichmond, Virginia  
Yale University School Of MedicineNew Haven, Connecticut  06520
Kansas City Cancer CenterKansas City, Missouri  64111
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
City of Hope Samaritan Bone Marrow Transplant ProgramPhoenix, Arizona  85006
Shands Teaching Hospital, University of FloridaGainesville, Florida  32610
Indiana Blood and Marrow Transplantation CenterBeech Grove, Indiana  46107
Nebraska Medical Center: Clarkson and University HospitalsOmaha, Nebraska  68198