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

Phase 3

Completed

Conditions: Lymphoma, Non-Hodgkin

Interventions: Drug: Granulocyte colony-stimulating factor plus plerixafor
Drug: Granulocyte colony-stimulating factor plus placebo

Registration Number: NCT00103610

Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 298

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF plus plerixafor	Granulocyte colony-stimulating factor plus plerixafor	-
G-CSF plus placebo	Granulocyte colony-stimulating factor plus placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	Days 5 to 8	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	up to Day 38	Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.
Graft Durability at 100 Days Post Transplantation	approximately Day 138	The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
Graft Durability at 12 Months Post Transplantation	approximately Month 13	The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment	Up to Month 13	The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5\10\^9/L for 3 consecutive days or ≥ 1.0\10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	up to Day 8	Proportion of participants achieving a target of \>=2\*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.
Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg	up to Day 8	The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5\*10\^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.
Median Number of Days to Platelet (PLT) Engraftment	Up to Month 13	The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20\*10\^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.
Graft Durability at 6 Months Post Transplantation	approximately Month 7	The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.

Trial Locations

Locations (32): City of Hope Samaritan Bone Marrow Transplant Program
🇺🇸
Phoenix, Arizona, United States
City of Hope National Medical Center
🇺🇸
Duarte, California, United States
Rocky Mountain Cancer Center
🇺🇸
Denver, Colorado, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Shands Teaching Hospital, University of Florida
🇺🇸
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸
Tampa, Florida, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation Center
🇺🇸
Beech Grove, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
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City of Hope Samaritan Bone Marrow Transplant Program
🇺🇸Phoenix, Arizona, United States