NCT00103610 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2014-03-13

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Number of Participants With Adverse Events

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outcome · POSTED

Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis

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outcome · POSTED

Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg

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outcome · POSTED

Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment

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outcome · POSTED

Median Number of Days to Platelet (PLT) Engraftment

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outcome · POSTED

Graft Durability at 100 Days Post Transplantation

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outcome · POSTED

Graft Durability at 6 Months Post Transplantation

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outcome · POSTED

Graft Durability at 12 Months Post Transplantation

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
maximum Age: 78 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Granulocyte colony-stimulating factor plus plerixafor
label
G-CSF plus plerixafor
type
EXPERIMENTAL
intervention Names
Drug: Granulocyte colony-stimulating factor plus placebo
label
G-CSF plus placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
G-CSF plus plerixafor
description
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
name
Granulocyte colony-stimulating factor plus plerixafor
other Names
AMD3100
Mozobil
type
DRUG
arm Group Labels
G-CSF plus placebo
description
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
name
Granulocyte colony-stimulating factor plus placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 298
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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

secondary Outcomes

description
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.
measure
Number of Participants With Adverse Events
time Frame
up to Day 38
description
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.
measure
Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
time Frame
up to Day 8
description
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.
measure
Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg
time Frame
up to Day 8
description
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.
measure
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
time Frame
Up to Month 13
description
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.
measure
Median Number of Days to Platelet (PLT) Engraftment
time Frame
Up to Month 13
description
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.
measure
Graft Durability at 100 Days Post Transplantation
time Frame
approximately Day 138
description
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.
measure
Graft Durability at 6 Months Post Transplantation
time Frame
approximately Month 7
description
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.
measure
Graft Durability at 12 Months Post Transplantation
time Frame
approximately Month 13

Full study description

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.

Source references

references

citation
DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.
pmid
19720922
type
RESULT