ECO-1: Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00206726
Collaborator
(none)
60
27
1
35
2.2
0.1
Study Details
Study Description
Brief Summary
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy.
Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Study Start Date
:
May 1, 2005
Actual Primary Completion Date
:
Apr 1, 2008
Actual Study Completion Date
:
Apr 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alemtuzumab plus Fludarabine Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days. |
Drug: Alemtuzumab plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
Outcome Measures
Primary Outcome Measures
- Complete Response (CR) [28 days after last cycle with confirmation 2 months later]
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.
Secondary Outcome Measures
- Overall Response (OR) [28 days after last cycle with confirmation 2 months later]
Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.
- Overall Survival (OS) [1 year after start of treatment]
Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year
- Progression-free Survival (PFS) [1 year after start of treatment]
Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year
- Percentage of Participants With Overall Response at Different Observation Times [from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier]
Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.
- Number of Participants With Minimal Residual Disease (MRD) [When CR is confirmed]
Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient must have confirmed B-CLL.
-
Patients must have received at least one prior therapy and must require treatment for active disease
Exclusion Criteria:
-
Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study.
-
History of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy
-
History of human immunodeficiency virus (HIV) positivity.
-
Active infection requiring treatment
-
Pregnancy or lactation
-
Other severe, concurrent diseases or mental disorders
-
Central nervous system involvement of chronic lymphocytic leukemia (CLL)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35223 | |
| 2 | Berkeley | California | United States | 94704 | |
| 3 | Burbank | California | United States | 91595 | |
| 4 | Concord | California | United States | 94520 | |
| 5 | Stanford | California | United States | 94305-5118 | |
| 6 | Washington | District of Columbia | United States | 20422 | |
| 7 | Lakeland | Florida | United States | 33805 | |
| 8 | Atlanta | Georgia | United States | 30322 | |
| 9 | Aurora | Illinois | United States | 60504 | |
| 10 | Chicago | Illinois | United States | 60637 | |
| 11 | Springfield | Illinois | United States | 62703 | |
| 12 | Metairie | Louisiana | United States | 70006 | |
| 13 | Clinton | Maryland | United States | 20735 | |
| 14 | Boston | Massachusetts | United States | 02115 | |
| 15 | Jackson | Michigan | United States | 39202 | |
| 16 | Minneapolis | Minnesota | United States | 55417 | |
| 17 | Reno | Nevada | United States | 89520 | |
| 18 | Lebanon | New Hampshire | United States | 03756-0001 | |
| 19 | New Brunswick | New Jersey | United States | 08903-2681 | |
| 20 | Albany | New York | United States | 12208-3473 | |
| 21 | Northport | New York | United States | 11768 | |
| 22 | Lawton | Oklahoma | United States | 73505 | |
| 23 | Portland | Oregon | United States | 97239 | |
| 24 | Pittsburgh | Pennsylvania | United States | 15224 | |
| 25 | Johnson City | Tennessee | United States | 37604 | |
| 26 | Tacoma | Washington | United States | 98431-5000 | |
| 27 | Milwaukee | Wisconsin | United States | 53226-3596 |
Sponsors and Collaborators
- Genzyme, a Sanofi Company
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00206726
Other Study ID Numbers:
- 13603
- 305825
First Posted:
Sep 21, 2005
Last Update Posted:
Aug 29, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 27 centers in the United States from 12 May 2005 (date of first participant's first visit) to 10 April 2008 (date of last participant's last visit) |
|---|---|
| Pre-assignment Detail | 66 screened, 6 screen failures, 60 enrolled and registered (Intent-to-Treat [ITT] population), 3 withdrew consent prior to receiving therapy = 57 treated (Safety population); 41 received at least 4 therapy cycles with no major protocol deviation or progressed/relapsed or died before completing 4 cycles (Per Protocol [PP] population) |
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Period Title: Overall Study | |
| STARTED | 60 |
| Treatment Started | 57 |
| 4 Cycles Completed | 41 |
| COMPLETED | 9 |
| NOT COMPLETED | 51 |
Baseline Characteristics
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Overall Participants | 60 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
62
|
| Sex: Female, Male (Count of Participants) | |
| Female |
19
31.7%
|
| Male |
41
68.3%
|
| Beta 2-micro-globulin (Number) [Number] | |
| < 2 milligrams per liter (mg/L) or missing |
12
20%
|
| >= 2mg/L |
48
80%
|
| Lymph node size (participants) [Number] | |
| < 5 centimeters (cm) |
43
71.7%
|
| >= 5 cm |
12
20%
|
| missing |
5
8.3%
|
| Number of prior cancer therapies (Number) [Number] | |
| 1 |
10
16.7%
|
| 2 |
14
23.3%
|
| 3 |
13
21.7%
|
| 4 |
5
8.3%
|
| 5-10 |
16
26.7%
|
| >10 |
2
3.3%
|
| Rai Stage (participants) [Number] | |
| 0 |
5
8.3%
|
| 1 to 2 |
22
36.7%
|
| 3 to 4 |
33
55%
|
| Missing |
0
0%
|
Outcome Measures
| Title | Complete Response (CR) |
|---|---|
| Description | Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular. |
| Time Frame | 28 days after last cycle with confirmation 2 months later |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population (all enrolled and registered subjects). |
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Measure Participants | 60 |
| Number [Percentage of participants with CR] |
8.3
13.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alemtuzumab Plus Fludarabine |
|---|---|---|
| Comments | Comparison of CR rate versus 2 percent (%) historic control (p-value and 90% confidence interval) | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | 2-sided p-value computed from an exact binomial test comparing the observed rate versus 2% historical rate | |
| Method | exact binomial test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | CR rate |
| Estimated Value | 0.0833 | |
| Confidence Interval |
() 90% 0.0334 to 0.1673 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Overall Response (OR) |
|---|---|
| Description | Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease. |
| Time Frame | 28 days after last cycle with confirmation 2 months later |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population (all subjects enrolled and registered). |
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Measure Participants | 60 |
| Number [Percentage of participants with CR or PR] |
28.3
47.2%
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year |
| Time Frame | 1 year after start of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population (all subjects treated) |
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Measure Participants | 57 |
| Number [Percentage of participants alive] |
86.4
144%
|
| Title | Progression-free Survival (PFS) |
|---|---|
| Description | Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year |
| Time Frame | 1 year after start of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population (all subjects enrolled and registered). As three subjects never received study medication, they were to be censored at day 1 for all time-to-event analyses. Thus, the Kaplan-Meier estimates beyond day one are the same for both, the ITT and the safety population. |
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Measure Participants | 60 |
| Number [percentage alive without progression] |
48.8
|
| Title | Percentage of Participants With Overall Response at Different Observation Times |
|---|---|
| Description | Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease. |
| Time Frame | from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who achieved Overall Response (OR) defined as number of subjects who achieved CR + number of subjects who achieved PR |
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Measure Participants | 17 |
| After 90 days |
76.5
127.5%
|
| After 180 days |
64.7
107.8%
|
| After 270 days |
29.4
49%
|
| Title | Number of Participants With Minimal Residual Disease (MRD) |
|---|---|
| Description | Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples. |
| Time Frame | When CR is confirmed |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants for whom CR was confirmed |
| Arm/Group Title | Alemtuzumab Plus Fludarabine |
|---|---|
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Measure Participants | 5 |
| Positive |
3
5%
|
| Negative |
2
3.3%
|
| Not Assessed |
0
0%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Alemtuzumab Plus Fludarabine | |
| Arm/Group Description | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days | |
All Cause Mortality |
||
| Alemtuzumab Plus Fludarabine | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Alemtuzumab Plus Fludarabine | ||
| Affected / at Risk (%) | # Events | |
| Total | 41/57 (71.9%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 9/57 (15.8%) | |
| Coagulopathy | 1/57 (1.8%) | |
| Febrile neutropenia | 13/57 (22.8%) | |
| Leukopenia | 2/57 (3.5%) | |
| Lymphopenia | 1/57 (1.8%) | |
| Neutropenia | 2/57 (3.5%) | |
| Pancytopenia | 2/57 (3.5%) | |
| Thrombocytopenia | 2/57 (3.5%) | |
| Cardiac disorders | ||
| Angina pectoris | 1/57 (1.8%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/57 (1.8%) | |
| Diarrhoea | 3/57 (5.3%) | |
| Gastrointestinal haemorrhage | 1/57 (1.8%) | |
| Intestinal ischaemia | 1/57 (1.8%) | |
| Lower gastrointestinal haemorrhage | 1/57 (1.8%) | |
| Nausea | 3/57 (5.3%) | |
| Vomiting | 3/57 (5.3%) | |
| General disorders | ||
| Asthenia | 2/57 (3.5%) | |
| Chills | 1/57 (1.8%) | |
| Disease progression | 3/57 (5.3%) | |
| Fatigue | 2/57 (3.5%) | |
| Influenza like illness | 1/57 (1.8%) | |
| Multi-organ failure | 1/57 (1.8%) | |
| Pyrexia | 11/57 (19.3%) | |
| Hepatobiliary disorders | ||
| Cholangitis | 1/57 (1.8%) | |
| Cholelithiasis | 1/57 (1.8%) | |
| Hepatic failure | 1/57 (1.8%) | |
| Infections and infestations | ||
| Acute sinusitis | 1/57 (1.8%) | |
| Adenovirus infection | 1/57 (1.8%) | |
| Bacteraemia | 2/57 (3.5%) | |
| Blastomycosis | 1/57 (1.8%) | |
| Bronchopneumonia | 1/57 (1.8%) | |
| Bronchopulmonary aspergillosis | 1/57 (1.8%) | |
| Cytomegalovirus infection | 1/57 (1.8%) | |
| Enterococcal bacteriaemia | 1/57 (1.8%) | |
| Gastroenteritis | 1/57 (1.8%) | |
| Infection | 1/57 (1.8%) | |
| Liver abscess | 1/57 (1.8%) | |
| Lower respiratory tract infection bacterial | 1/57 (1.8%) | |
| Lung infection pseudomonal | 1/57 (1.8%) | |
| Pneumonia | 4/57 (7%) | |
| Sepsis | 1/57 (1.8%) | |
| Sepsis syndrome | 1/57 (1.8%) | |
| Septic shock | 3/57 (5.3%) | |
| Sinusitis | 1/57 (1.8%) | |
| Sinusitis fungal | 1/57 (1.8%) | |
| Splenic abscess | 1/57 (1.8%) | |
| Urinary tract infection | 2/57 (3.5%) | |
| Investigations | ||
| Blood calcium decreased | 1/57 (1.8%) | |
| Blood creatinine increased | 1/57 (1.8%) | |
| Epstein-Barr virus test positive | 1/57 (1.8%) | |
| Metabolism and nutrition disorders | ||
| Anorexia | 1/57 (1.8%) | |
| Dehydration | 3/57 (5.3%) | |
| Hyperkalaemia | 1/57 (1.8%) | |
| Hyponatraemia | 2/57 (3.5%) | |
| Metabolic acidosis | 1/57 (1.8%) | |
| Musculoskeletal and connective tissue disorders | ||
| Muscular weakness | 1/57 (1.8%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Chronic lymphocytic leukaemia transformation | 2/57 (3.5%) | |
| Lymphoma | 1/57 (1.8%) | |
| Prolymphocytic Leukaemia | 1/57 (1.8%) | |
| Nervous system disorders | ||
| Headache | 1/57 (1.8%) | |
| Hypoxic encephalopathy | 1/57 (1.8%) | |
| Myelitis | 1/57 (1.8%) | |
| Neuropathy peripheral | 1/57 (1.8%) | |
| Neurotoxicity | 1/57 (1.8%) | |
| Syncope | 1/57 (1.8%) | |
| Psychiatric disorders | ||
| Confusional state | 1/57 (1.8%) | |
| Disorientation | 1/57 (1.8%) | |
| Mental status changes | 2/57 (3.5%) | |
| Renal and urinary disorders | ||
| Obstructive uropathy | 1/57 (1.8%) | |
| Renal failure | 3/57 (5.3%) | |
| Renal failure acute | 3/57 (5.3%) | |
| Renal tubular necrosis | 1/57 (1.8%) | |
| Urinary incontinence | 1/57 (1.8%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 1/57 (1.8%) | |
| Dyspnoea | 2/57 (3.5%) | |
| Haemoptysis | 1/57 (1.8%) | |
| Hypoxia | 3/57 (5.3%) | |
| Pneumonia aspiration | 1/57 (1.8%) | |
| Respiratory failure | 2/57 (3.5%) | |
| Vascular disorders | ||
| Haemorrhage | 1/57 (1.8%) | |
| Hypotension | 2/57 (3.5%) | |
Other (Not Including Serious) Adverse Events |
||
| Alemtuzumab Plus Fludarabine | ||
| Affected / at Risk (%) | # Events | |
| Total | 55/57 (96.5%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 30/57 (52.6%) | |
| Eosinophilia | 1/57 (1.8%) | |
| Febrile neutropenia | 2/57 (3.5%) | |
| Granulocytopenia | 6/57 (10.5%) | |
| Haemolysis | 1/57 (1.8%) | |
| Haemolytic Anaemia | 5/57 (8.8%) | |
| Leukocytosis | 1/57 (1.8%) | |
| Leukopenia | 18/57 (31.6%) | |
| Lymphadenopathy | 2/57 (3.5%) | |
| Lymphocytosis | 1/57 (1.8%) | |
| Lymphopenia | 2/57 (3.5%) | |
| Neutropenia | 34/57 (59.6%) | |
| Pancytopenia | 2/57 (3.5%) | |
| Thrombocytopenia | 26/57 (45.6%) | |
| White blood cell disorder | 3/57 (5.3%) | |
| Cardiac disorders | ||
| Palpitations | 1/57 (1.8%) | |
| Sinus Tachycardia | 1/57 (1.8%) | |
| Tachycardia | 6/57 (10.5%) | |
| Ear and labyrinth disorders | ||
| Ear pain | 3/57 (5.3%) | |
| Tinnitus | 1/57 (1.8%) | |
| Vertigo | 1/57 (1.8%) | |
| Endocrine disorders | ||
| Goitre | 1/57 (1.8%) | |
| Eye disorders | ||
| Diplopia | 1/57 (1.8%) | |
| Eye pain | 1/57 (1.8%) | |
| Eyelid oedema | 1/57 (1.8%) | |
| Vision blurred | 2/57 (3.5%) | |
| Gastrointestinal disorders | ||
| Abdominal Distension | 2/57 (3.5%) | |
| Abdominal discomfort | 2/57 (3.5%) | |
| Abdominal pain | 7/57 (12.3%) | |
| Abdominal pain upper | 1/57 (1.8%) | |
| Abdominal tenderness | 1/57 (1.8%) | |
| Chapped lips | 1/57 (1.8%) | |
| Colitis | 1/57 (1.8%) | |
| Constipation | 15/57 (26.3%) | |
| Diarrhoea | 19/57 (33.3%) | |
| Dry mouth | 1/57 (1.8%) | |
| Dyspepsia | 4/57 (7%) | |
| Dysphagia | 4/57 (7%) | |
| Faeces hard | 1/57 (1.8%) | |
| Flatulence | 1/57 (1.8%) | |
| Gastric ulcer | 1/57 (1.8%) | |
| Gastrointestinal Haemorrhage | 1/57 (1.8%) | |
| Gastrooesophageal reflux disease | 3/57 (5.3%) | |
| Glossodynia | 1/57 (1.8%) | |
| Nausea | 32/57 (56.1%) | |
| Odynophagia | 1/57 (1.8%) | |
| Oesophagitis | 1/57 (1.8%) | |
| Rectal haemorrhage | 1/57 (1.8%) | |
| Toothache | 1/57 (1.8%) | |
| Vomiting | 18/57 (31.6%) | |
| General disorders | ||
| Asthenia | 6/57 (10.5%) | |
| Axillary pain | 1/57 (1.8%) | |
| Chest discomfort | 2/57 (3.5%) | |
| Chills | 18/57 (31.6%) | |
| Disease progression | 13/57 (22.8%) | |
| Early satiety | 1/57 (1.8%) | |
| Face oedema | 1/57 (1.8%) | |
| Fatigue | 30/57 (52.6%) | |
| Hernia pain | 1/57 (1.8%) | |
| Hypothermia | 1/57 (1.8%) | |
| Infusion related reaction | 1/57 (1.8%) | |
| Injection site erythema | 5/57 (8.8%) | |
| Injection site irritation | 1/57 (1.8%) | |
| Injection site pain | 3/57 (5.3%) | |
| Injection site rash | 1/57 (1.8%) | |
| Injection site reaction | 3/57 (5.3%) | |
| Injection site warmth | 1/57 (1.8%) | |
| Local swelling | 1/57 (1.8%) | |
| Mucosal erosion | 1/57 (1.8%) | |
| Mucosal inflammation | 3/57 (5.3%) | |
| Non-cardiac chest pain | 1/57 (1.8%) | |
| Oedema | 2/57 (3.5%) | |
| Oedema peripheral | 7/57 (12.3%) | |
| Pain | 5/57 (8.8%) | |
| Pyrexia | 27/57 (47.4%) | |
| Suprapubic pain | 1/57 (1.8%) | |
| Hepatobiliary disorders | ||
| Cholecystitis | 1/57 (1.8%) | |
| Cholelithiasis | 1/57 (1.8%) | |
| Hepatic mass | 1/57 (1.8%) | |
| Hepatomegaly | 1/57 (1.8%) | |
| Hyperbilirubinaemia | 1/57 (1.8%) | |
| Jaundice | 1/57 (1.8%) | |
| Immune system disorders | ||
| Hypogammaglobulinaemia | 1/57 (1.8%) | |
| Immunosuppression | 1/57 (1.8%) | |
| Seasonal allergy | 1/57 (1.8%) | |
| Infections and infestations | ||
| Body tinea | 1/57 (1.8%) | |
| Bronchitis | 3/57 (5.3%) | |
| Candidiasis | 1/57 (1.8%) | |
| Chronic sinusitis | 1/57 (1.8%) | |
| Cytomegalovirus infection | 2/57 (3.5%) | |
| Ear infection | 1/57 (1.8%) | |
| Gastroenteritis | 1/57 (1.8%) | |
| Gingival infection | 2/57 (3.5%) | |
| Herpes zoster | 4/57 (7%) | |
| Infection | 1/57 (1.8%) | |
| Lung infection | 1/57 (1.8%) | |
| Mycobacterium avium complex infection | 1/57 (1.8%) | |
| Nasopharyngitis | 5/57 (8.8%) | |
| Pharyngitis | 1/57 (1.8%) | |
| Pneumonia | 4/57 (7%) | |
| Pneumonia cytomegaloviral | 1/57 (1.8%) | |
| Respiratory tract infection | 1/57 (1.8%) | |
| Rhinitis | 8/57 (14%) | |
| Sepsis | 2/57 (3.5%) | |
| Sinusitis | 4/57 (7%) | |
| Staphylococcal infection | 1/57 (1.8%) | |
| Upper respiratory tract infection | 2/57 (3.5%) | |
| Urinary tract infection | 1/57 (1.8%) | |
| Injury, poisoning and procedural complications | ||
| Contusion | 3/57 (5.3%) | |
| Excoriation | 1/57 (1.8%) | |
| Fall | 1/57 (1.8%) | |
| Medical device pain | 1/57 (1.8%) | |
| Procedural pain | 2/57 (3.5%) | |
| Sunburn | 1/57 (1.8%) | |
| Investigations | ||
| Alanine aminotransferase increased | 3/57 (5.3%) | |
| Aspartate Aminotransferase increased | 3/57 (5.3%) | |
| Bacterial test positive | 2/57 (3.5%) | |
| Blood alkaline phosphatase increased | 3/57 (5.3%) | |
| Blood bicarbonate decreased | 1/57 (1.8%) | |
| Blood bilirubin unconjugated increased | 1/57 (1.8%) | |
| Blood creatinine increased | 1/57 (1.8%) | |
| Blood lactate dehydrogenase increased | 1/57 (1.8%) | |
| Blood potassium decreased | 1/57 (1.8%) | |
| Blood pressure increased | 1/57 (1.8%) | |
| Body temperature increased | 1/57 (1.8%) | |
| Cardiac murmur | 1/57 (1.8%) | |
| Cytomegalovirus test positive | 22/57 (38.6%) | |
| Granulocyte count decreased | 1/57 (1.8%) | |
| Haemoglobin decreased | 4/57 (7%) | |
| Heart rate increased | 1/57 (1.8%) | |
| Heart sounds abnormal | 1/57 (1.8%) | |
| Neutrophil count decreased | 6/57 (10.5%) | |
| Platelet count decreased | 4/57 (7%) | |
| Red blood cell count decreased | 1/57 (1.8%) | |
| Transaminases increased | 2/57 (3.5%) | |
| Troponin increased | 1/57 (1.8%) | |
| Viral DNA test positive | 1/57 (1.8%) | |
| Weight decreased | 5/57 (8.8%) | |
| White blood cell count decreased | 7/57 (12.3%) | |
| Metabolism and nutrition disorders | ||
| Acidosis | 1/57 (1.8%) | |
| Anorexia | 13/57 (22.8%) | |
| Cachexia | 1/57 (1.8%) | |
| Calcium deficiency | 1/57 (1.8%) | |
| Decreased appetite | 6/57 (10.5%) | |
| Dehydration | 3/57 (5.3%) | |
| Glucose tolerance impaired | 1/57 (1.8%) | |
| Hypercalcaemia | 1/57 (1.8%) | |
| Hyperglycaemia | 4/57 (7%) | |
| Hyperkalaemia | 3/57 (5.3%) | |
| Hyperlipidaemia | 1/57 (1.8%) | |
| Hypoalbuminaemia | 1/57 (1.8%) | |
| Hypocalcaemia | 2/57 (3.5%) | |
| Hypokalaemia | 9/57 (15.8%) | |
| Hypomagnesaemia | 4/57 (7%) | |
| Hyponatraemia | 6/57 (10.5%) | |
| Hypophosphataemia | 1/57 (1.8%) | |
| Hypovolaemia | 1/57 (1.8%) | |
| Magnesium deficiency | 1/57 (1.8%) | |
| Metabolic acidosis | 1/57 (1.8%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 5/57 (8.8%) | |
| Back pain | 7/57 (12.3%) | |
| Bone pain | 4/57 (7%) | |
| Buttock pain | 1/57 (1.8%) | |
| Chest wall pain | 1/57 (1.8%) | |
| Muscle spasms | 1/57 (1.8%) | |
| Muscucoskeletal stiffness | 1/57 (1.8%) | |
| Muscular weakness | 1/57 (1.8%) | |
| Musculoskeletal pain | 1/57 (1.8%) | |
| Myalgia | 5/57 (8.8%) | |
| Neck pain | 1/57 (1.8%) | |
| Pain in extremity | 3/57 (5.3%) | |
| Shoulder pain | 2/57 (3.5%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Chronic lymphocytic leukaemia | 1/57 (1.8%) | |
| Lipoma | 1/57 (1.8%) | |
| Nervous system disorders | ||
| Convulsion | 1/57 (1.8%) | |
| Dizziness | 7/57 (12.3%) | |
| Dysgeusia | 2/57 (3.5%) | |
| Facial palsy | 1/57 (1.8%) | |
| Headache | 6/57 (10.5%) | |
| Hypoaesthesia | 3/57 (5.3%) | |
| Memory impairment | 1/57 (1.8%) | |
| Neuropathy peripheral | 1/57 (1.8%) | |
| Paraesthesia | 1/57 (1.8%) | |
| Peripheral sensory neuropathy | 1/57 (1.8%) | |
| Peroneal nerve palsy | 1/57 (1.8%) | |
| Post herpetic neuralgia | 1/57 (1.8%) | |
| Sinus headache | 1/57 (1.8%) | |
| Somnolence | 1/57 (1.8%) | |
| Syncope | 1/57 (1.8%) | |
| Tremor | 2/57 (3.5%) | |
| Psychiatric disorders | ||
| Anxiety | 3/57 (5.3%) | |
| Confusional state | 3/57 (5.3%) | |
| Depression | 2/57 (3.5%) | |
| Disorientation | 1/57 (1.8%) | |
| Insomnia | 7/57 (12.3%) | |
| Renal and urinary disorders | ||
| Azotaemia | 1/57 (1.8%) | |
| Dysuria | 1/57 (1.8%) | |
| Haematuria | 1/57 (1.8%) | |
| Micturition disorder | 1/57 (1.8%) | |
| Micturition urgency | 1/57 (1.8%) | |
| Pollakiuria | 1/57 (1.8%) | |
| Proteinuria | 1/57 (1.8%) | |
| Renal failure | 1/57 (1.8%) | |
| Renal failure acute | 2/57 (3.5%) | |
| Urinary incontinence | 1/57 (1.8%) | |
| Urinary retention | 2/57 (3.5%) | |
| Reproductive system and breast disorders | ||
| Breast pain | 1/57 (1.8%) | |
| Epididymitis | 1/57 (1.8%) | |
| Erectile dysfunction | 1/57 (1.8%) | |
| Genital pruritus female | 1/57 (1.8%) | |
| Testicular pain | 1/57 (1.8%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Asthma | 1/57 (1.8%) | |
| Cough | 18/57 (31.6%) | |
| Crackles lung | 2/57 (3.5%) | |
| Dysphonia | 2/57 (3.5%) | |
| Dyspnoea | 18/57 (31.6%) | |
| Dyspnoea exertional | 4/57 (7%) | |
| Epistaxis | 3/57 (5.3%) | |
| Haemoptysis | 1/57 (1.8%) | |
| Hiccups | 2/57 (3.5%) | |
| Hypoxia | 1/57 (1.8%) | |
| Nasal congestion | 1/57 (1.8%) | |
| Pharyngolaryngeal pain | 8/57 (14%) | |
| Pleural effusion | 2/57 (3.5%) | |
| Pleuritic pain | 1/57 (1.8%) | |
| Productive cough | 2/57 (3.5%) | |
| Pulmonary congestion | 2/57 (3.5%) | |
| Pulmonary haemorrhage | 1/57 (1.8%) | |
| Pulmonary mass | 1/57 (1.8%) | |
| Pulmonary oedema | 1/57 (1.8%) | |
| Respiratory distress | 1/57 (1.8%) | |
| Rhinitis allergic | 1/57 (1.8%) | |
| Rhinorrhoea | 1/57 (1.8%) | |
| Sinus congestion | 1/57 (1.8%) | |
| Throat lesion | 1/57 (1.8%) | |
| Wheezing | 4/57 (7%) | |
| Skin and subcutaneous tissue disorders | ||
| Actinic keratosis | 1/57 (1.8%) | |
| Alopecia | 1/57 (1.8%) | |
| Dermatitis allergic | 1/57 (1.8%) | |
| Drug eruption | 1/57 (1.8%) | |
| Ecchymosis | 3/57 (5.3%) | |
| Erythema | 2/57 (3.5%) | |
| Hyperhidrosis | 4/57 (7%) | |
| Intertrigo | 1/57 (1.8%) | |
| Night sweats | 6/57 (10.5%) | |
| Petechiae | 3/57 (5.3%) | |
| Pruritus | 6/57 (10.5%) | |
| Rash | 11/57 (19.3%) | |
| Rash erythematous | 1/57 (1.8%) | |
| Rash generalized | 1/57 (1.8%) | |
| Rash papular | 1/57 (1.8%) | |
| Skin hyperpigmentation | 1/57 (1.8%) | |
| Skin lesion | 1/57 (1.8%) | |
| Urticaria | 3/57 (5.3%) | |
| Vascular disorders | ||
| Haemorrhage | 1/57 (1.8%) | |
| Hot flush | 1/57 (1.8%) | |
| Hypertension | 2/57 (3.5%) | |
| Hypotension | 8/57 (14%) | |
| Orthostatic hypotension | 1/57 (1.8%) | |
| Pallor | 1/57 (1.8%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
| Name/Title | Trial Transparency Team |
|---|---|
| Organization | Sanofi |
| Phone | |
| Contact-us@sanofi.com |
Responsible Party:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00206726
Other Study ID Numbers:
- 13603
- 305825
First Posted:
Sep 21, 2005
Last Update Posted:
Aug 29, 2016
Last Verified:
Jul 1, 2016