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The Effect of Rituximab on Mobilization With AMD3100 (Plerixafor) Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00444912
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : July 29, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-Hodgkin Lymphoma
Hodgkin Disease
Interventions Drug: G-CSF plus plerixafor
Biological: rituximab
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Period Title: Overall Study
Started 15 15
Received Plerixafor 15 15
Received Transplant 14 14
Completed 12 13
Not Completed 3 2
Reason Not Completed
Death             1             2
Lost to Follow-up             1             0
Participant Failed Mobilization             1             0
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab Total
Hide Arm/Group Description Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
39.3  (11.3) 46.5  (14.9) 42.9  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
6
  40.0%
3
  20.0%
9
  30.0%
Male
9
  60.0%
12
  80.0%
21
  70.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Caucasian 12 10 22
African-American 3 1 4
Asian 0 0 0
Hispanic/Latino 0 2 2
Other 0 2 2
Disease Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Hodgkin disease (HD) 14 4 18
Non-Hodgkin lymphoma (NHL) 1 11 12
1.Primary Outcome
Title Summary of Adverse Events (AEs)
Hide Description Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.
Time Frame Day 1 and up to Day 59 (maximum time before start of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of study drug (G-CSF, plerixafor, or rituximab)
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
Participants Reporting at Least 1 AE 9 13
Participant Count of Mild AEs 7 12
Participant Count of Moderate AEs 2 0
Participant Count of Severe AEs 0 0
Participant Count of Life-Threatening AEs 0 1
AEs by Relationship - Not Related 1 0
AEs by Relationship - Probably Not Related 3 4
AEs by Relationship - Possibly Related 0 5
AEs by Relationship - Probably Related 2 3
AEs by Relationship - Definitely Related 3 1
2.Secondary Outcome
Title Median Cumulative Number of CD34+ Cells Collected During Apheresis
Hide Description Median total number of CD34+ cells collected during apheresis.
Time Frame Days 5-8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 15 15
Median (Full Range)
Unit of Measure: CD34+ cells (*10^6 / kg)
7.4
(0.9 to 14.1)
6.4
(2.5 to 10.9)
3.Secondary Outcome
Title Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration
Hide Description Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).
Time Frame Days 4-5
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants with peripheral blood CD34+ measurements on Days 4 and 5.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 6 11
Median (Full Range)
Unit of Measure: fold increase
2.4
(1.6 to 1321.3)
2.5
(1.6 to 68.5)
4.Secondary Outcome
Title Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg
Hide Description Median number of apheresis days in each treatment arm to collect a minimum of 3*10^6 CD34+ cells/kg.
Time Frame Days 5-8
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who achieved ≥3*10^cells/kg collected during apheresis.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: days
1.0
(1.0 to 3.0)
1.0
(1.0 to 2.0)
5.Secondary Outcome
Title Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg
Hide Description Median number of apheresis days in each treatment arm to reach the target of 5*10^6 CD34+ cells/kg.
Time Frame Days 5-8
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who achieved ≥5*10^cells/kg collected during apheresis.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 10 12
Median (Full Range)
Unit of Measure: days
1.0
(1.0 to 4.0)
2.0
(1.0 to 3.0)
6.Secondary Outcome
Title Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
Hide Description Median number of days from transplantation to PMN engraftment which 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.
Time Frame Days post transplantation (approximately Day 40)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who received a stem cell transplant and had PMN engraftment
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: days
13.0
(11.0 to 21.0)
13.5
(11.0 to 16.0)
7.Secondary Outcome
Title Median Number of Days to Platelet (PLT) Engraftment
Hide Description Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20*10^9/L without transfusion for the preceding 7 days or platelet counts ≥50*10^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.
Time Frame Days post transplantation (approximately Day 40)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who received a stem cell transplant and had PLT engraftment.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 14 13
Median (Full Range)
Unit of Measure: days
21.0
(13.0 to 31.0)
22.0
(16.0 to 28.0)
8.Secondary Outcome
Title Median Number of Days to Lymphocyte Engraftment
Hide Description Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5*10^8/L. Time to engraftment corresponded to the first day that criteria were met.
Time Frame Days post transplantation (approximately Day 40)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who received a stem cell transplant and had lymphocyte engraftment.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: days
14.5
(9.0 to 32.0)
14.0
(7.0 to 22.0)
9.Secondary Outcome
Title Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant
Hide Description [Not Specified]
Time Frame Approximately 7 months (6 months post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who received a stem cell transplant and had assessment performed 6 months post-transplant.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 5 4
Median (Full Range)
Unit of Measure: cells / μL
155.00
(61.00 to 311.00)
0.50
(0.00 to 4.00)
10.Secondary Outcome
Title Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant
Hide Description [Not Specified]
Time Frame 13 months (12 months post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who received a stem cell transplant and had assessment performed 12 months post-transplant.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: cells / μL
322.50
(189.00 to 518.00)
236.00
(0.00 to 457.00)
11.Secondary Outcome
Title The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day
Hide Description [Not Specified]
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 15 15
Median (Full Range)
Unit of Measure: percentage of total cells
2.83
(0.07 to 7.86)
0.09
(0.01 to 0.39)
12.Secondary Outcome
Title Number of Participants With Durable Engraftment 12 Months After Transplantation
Hide Description The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.
Time Frame Approximately 13 months (12 months post-transplant )
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population of participants who received a stem cell transplant and had a 12-month assessment.
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description:
Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: participants
12 13
Time Frame First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration (rituximab if applicable), and the rest period.
Adverse Event Reporting Description

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Each AE table includes all events, regardless of reported relationship to study treatment or grade.

 
Arm/Group Title G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Hide Arm/Group Description Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
All-Cause Mortality
G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   1/15 (6.67%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/15 (0.00%)  1/15 (6.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma  1  0/15 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
G-CSF and Plerixafor G-CSF and Plerixafor + Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   9/15 (60.00%)   13/15 (86.67%) 
Blood and lymphatic system disorders     
Anaemia  1  1/15 (6.67%)  1/15 (6.67%) 
Thrombocytopenia  1  0/15 (0.00%)  1/15 (6.67%) 
Cardiac disorders     
Tachycardia  1  0/15 (0.00%)  1/15 (6.67%) 
Eye disorders     
Conjunctival haemorrhage  1  0/15 (0.00%)  1/15 (6.67%) 
Visual impairment  1  0/15 (0.00%)  1/15 (6.67%) 
Gastrointestinal disorders     
Abdominal pain  1  0/15 (0.00%)  1/15 (6.67%) 
Constipation  1  0/15 (0.00%)  1/15 (6.67%) 
Diarrhoea  1  1/15 (6.67%)  2/15 (13.33%) 
Dry mouth  1  0/15 (0.00%)  1/15 (6.67%) 
Haemorrhoids  1  1/15 (6.67%)  0/15 (0.00%) 
Hypoaesthesia oral  1  0/15 (0.00%)  1/15 (6.67%) 
Nausea  1  1/15 (6.67%)  4/15 (26.67%) 
Paraesthesia oral  1  2/15 (13.33%)  2/15 (13.33%) 
Vomiting  1  0/15 (0.00%)  2/15 (13.33%) 
General disorders     
Catheter site discharge  1  1/15 (6.67%)  0/15 (0.00%) 
Catheter site erythema  1  0/15 (0.00%)  1/15 (6.67%) 
Catheter site pain  1  2/15 (13.33%)  0/15 (0.00%) 
Fatigue  1  0/15 (0.00%)  1/15 (6.67%) 
Injection site erythema  1  3/15 (20.00%)  1/15 (6.67%) 
Injection site irritation  1  1/15 (6.67%)  0/15 (0.00%) 
Injection site pain  1  1/15 (6.67%)  1/15 (6.67%) 
Injection site paraesthesia  1  1/15 (6.67%)  0/15 (0.00%) 
Injection site pruritus  1  1/15 (6.67%)  0/15 (0.00%) 
Mucosal inflammation  1  1/15 (6.67%)  1/15 (6.67%) 
Pain  1  0/15 (0.00%)  1/15 (6.67%) 
Pyrexia  1  1/15 (6.67%)  3/15 (20.00%) 
Infections and infestations     
Pneumonia  1  0/15 (0.00%)  1/15 (6.67%) 
Upper respiratory tract infection  1  1/15 (6.67%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Procedural complication  1  0/15 (0.00%)  1/15 (6.67%) 
Procedural pain  1  1/15 (6.67%)  0/15 (0.00%) 
Investigations     
Blood lactate dehydrogenase increased  1  1/15 (6.67%)  0/15 (0.00%) 
Urine pH increased  1  1/15 (6.67%)  0/15 (0.00%) 
Heart rate irregular  1  1/15 (6.67%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/15 (6.67%)  1/15 (6.67%) 
Hypokalaemia  1  0/15 (0.00%)  2/15 (13.33%) 
Hypomagnesaemia  1  0/15 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/15 (0.00%)  1/15 (6.67%) 
Back pain  1  0/15 (0.00%)  1/15 (6.67%) 
Bone pain  1  1/15 (6.67%)  2/15 (13.33%) 
Nervous system disorders     
Dizziness  1  0/15 (0.00%)  1/15 (6.67%) 
Dysgeusia  1  0/15 (0.00%)  1/15 (6.67%) 
Headache  1  1/15 (6.67%)  1/15 (6.67%) 
Paraesthesia  1  1/15 (6.67%)  0/15 (0.00%) 
Tremor  1  0/15 (0.00%)  1/15 (6.67%) 
Psychiatric disorders     
Insomnia  1  0/15 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders     
Pollakiuria  1  0/15 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/15 (0.00%)  1/15 (6.67%) 
Respiratory alkalosis  1  0/15 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/15 (0.00%)  1/15 (6.67%) 
Hypoaesthesia facial  1  0/15 (0.00%)  1/15 (6.67%) 
Night sweats  1  0/15 (0.00%)  1/15 (6.67%) 
Vascular disorders     
Hot flush  1  0/15 (0.00%)  2/15 (13.33%) 
Hypotension  1  0/15 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Medical Information
Organization: Genzyme
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00444912     History of Changes
Other Study ID Numbers: AMD31002113
First Submitted: March 7, 2007
First Posted: March 8, 2007
Results First Submitted: June 25, 2010
Results First Posted: July 29, 2010
Last Update Posted: March 13, 2014