A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00858117
• Collaborator: Bayer (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 88
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving alemtuzumab together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: Alemtuzumab; Biological: Rituximab	Phase 2

Detailed Description

OBJECTIVES:

• To determine the response rate in patients with previously untreated B-cell chronic lymphocytic leukemia treated with alemtuzumab and rituximab.

• To evaluate the toxicity of alemtuzumab and rituximab in these patients.

OUTLINE: Patients receive alemtuzumab subcutaneously on days 1, 3, and 5 in weeks 1-18 and rituximab IV on day 1 in weeks 3, 5, 7, 9, 11, 13, 15, and 17 in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples are collected periodically for laboratory biomarker studies. Samples are analyzed for surface markers (e.g., CD3, CD4, CD8, CD10, CD19, CD20, CD25, CD38, CD52, Zap-70) and IgVH by PCR, flow cytometry, and FISH. Samples are also analyzed for alemtuzumab and anti-alemtuzumab antibody levels by flow cytometry.

After completion of study treatment, patients are followed periodically for 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL
• Actual Study Start Date: Sep 26, 2005
• Actual Primary Completion Date: Mar 17, 2010
• Actual Study Completion Date: Jan 24, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alemtuzumab and Rituximab Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.	Biological: Alemtuzumab; Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks; Other Names: Campath-1H ; Biological: Rituximab; Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks; Other Names: Rituxan

Outcome Measures

Primary Outcome Measures

1. Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination [At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years]

   Response rate (complete remission(CR) + partial remission(PR)) will be, assessed by NCI-WG 1996 criteria with lymphadenopathy and organomegaly measured during physical examination. CR=Absence of lymphadenopathy and constitutional symptoms, Normal CBC (leukocytes ≥ 1500/μl, Platelets >100,000/μl, Hemoglobin > 11.0 gm/dl), peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with < 30% of nucleated cells being lymphocytes. PR=absence of constitutional symptoms, ≥ 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, ≥ 50% reduction in lymphadenopathy, ≥ 50% reduction in size of liver and/or spleen and one of the following: polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline platelets > 100,000/μl or 50% improvement over baseline or hemoglobin > 11.0 gm/dl or 50% improvement over baseline without transfusions

2. Number of Patients Treated With Alemtuzumab and Rituximab Combination With Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans [At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years]

   Response rate (complete remission(CR) + partial response(PR)) will be assessed by NCI-WG 1996 criteria with measurements of the lymph nodes and spleen size by CT scans. Best response at any timepoint is captured below. CR= absence of significant lymphadenopathy (e.g. lymph nodes > 1.5 cm in their greatest transverse diameter) and no hepatomegaly or splenomegaly. PR=reduction in lymphadenopathy as defined by the following: (a) a decrease in lymph node size by 50% or more either in the sum products of up to six lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy; (b) no increase in any lymph node, and no new enlarged lymph node; in small lymph nodes (< 2cm), an increase of less than 25% was not considered to be significant and a reduction in the noted pretreatment enlargement of the spleen or liver by 50% or more.

Secondary Outcome Measures

1. Toxicity of the Study Medications, Alemtuzumab and Rituximab [During treatment, 18 weeks]

   Toxicity data will be collected at visits during 18 weeks of treatment and include adverse events considered at least possibly related to either study drugs (Alemtuzumab and Rituximab) and graded 3-5 using CTCAE 3.0. In general grading is as follows: Grade 1=mild Grade 2=moderate Grade 3=severe Grade 4=life threatening Grade 5=death Reported below are the number of patients who experienced each event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following criteria:

• Peripheral blood absolute lymphocyte count > 5,000/mm³

• Small- to moderate-size lymphocytes with < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts

• Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the following:

• Predominant population of cells share B-cell antigens with CD-5 in the absence of other pan-T-cell markers (e.g., CD-3, CD-2)

• B-cell expresses either lambda or kappa light chains

• Surface immunoglobulin with low-cell surface density expression NOTE: *Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL

• Requires therapy, as indicated by ≥ 1 of the following criteria:

• Unintentional weight loss > 10% within the past 6 months

• Extreme fatigue (i.e., ECOG performance status 2)

• Fevers > 100.5°F for 2 weeks without evidence of infection

• Night sweats without evidence of infection

• Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelet count < 100,000/mm³)

• Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly

• Massive nodes/clusters (> 5 cm), progressive symptomatic adenopathy, or adenopathy resulting in end-organ damage

• Progressive lymphocytosis with an increase of > 50% over 2 months or an anticipated doubling time < 6 months

• Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,000/mm³*

• Platelet count ≥ 50,000/mm³*

• Hemoglobin ≥ 10 g/dL*

• Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance > 40 mL/min

• Bilirubin < 2 mg/dL

• AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No active autoimmune anemia or thrombocytopenia

• No active infection requiring oral or intravenous antibiotics

• No second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless curatively treated ≥ 2 years ago NOTE: *If cytopenias are due to degree of bone marrow involvement, patient may be eligible at the discretion of the principal investigator.

PRIOR CONCURRENT THERAPY:

• Prior corticosteroid therapy allowed

• No prior cytotoxic therapy (other than corticosteroids)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University, Northwestern Medical Faculty Foundation	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Bayer

Investigators

• Principal Investigator: Olga Frankfurt, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT00858117
• Other Study ID Numbers: NU 04H6; NU 04H6; STU00004494
• First Posted: Mar 9, 2009
• Last Update Posted: Nov 6, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Northwestern University: B-cell chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
• Additional relevant MeSH terms: Leukemia; Rituximab; Alemtuzumab

Study Results

Participant Flow

Recruitment Details	The study opened for accrual on 29th March 2005 with the first patient starting treatment 26th September 2005 and an accrual goal of 30 patients. The study closed to further enrollment on the 26th October 2009 with 30 patients treated on study.

Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Period Title: Treatment on Study
STARTED	30
Completed 18 Weeks of Treatment	28
COMPLETED	28
NOT COMPLETED	2
Period Title: Treatment on Study
STARTED	30
COMPLETED	17
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 66.7%
>=65 years	10 33.3%
Sex: Female, Male (Count of Participants)
Female	10 33.3%
Male	20 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.3%
Not Hispanic or Latino	29 96.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 6.7%
White	28 93.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination
Description	Response rate (complete remission(CR) + partial remission(PR)) will be, assessed by NCI-WG 1996 criteria with lymphadenopathy and organomegaly measured during physical examination. CR=Absence of lymphadenopathy and constitutional symptoms, Normal CBC (leukocytes ≥ 1500/μl, Platelets >100,000/μl, Hemoglobin > 11.0 gm/dl), peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with < 30% of nucleated cells being lymphocytes. PR=absence of constitutional symptoms, ≥ 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, ≥ 50% reduction in lymphadenopathy, ≥ 50% reduction in size of liver and/or spleen and one of the following: polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline platelets > 100,000/μl or 50% improvement over baseline or hemoglobin > 11.0 gm/dl or 50% improvement over baseline without transfusions
Time Frame	At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Measure Participants	30
Count of Participants [Participants]	30 100%

2. Primary Outcome

Title	Number of Patients Treated With Alemtuzumab and Rituximab Combination With Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans
Description	Response rate (complete remission(CR) + partial response(PR)) will be assessed by NCI-WG 1996 criteria with measurements of the lymph nodes and spleen size by CT scans. Best response at any timepoint is captured below. CR= absence of significant lymphadenopathy (e.g. lymph nodes > 1.5 cm in their greatest transverse diameter) and no hepatomegaly or splenomegaly. PR=reduction in lymphadenopathy as defined by the following: (a) a decrease in lymph node size by 50% or more either in the sum products of up to six lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy; (b) no increase in any lymph node, and no new enlarged lymph node; in small lymph nodes (< 2cm), an increase of less than 25% was not considered to be significant and a reduction in the noted pretreatment enlargement of the spleen or liver by 50% or more.
Time Frame	At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Measure Participants	30
Count of Participants [Participants]	21 70%

3. Secondary Outcome

Title	Toxicity of the Study Medications, Alemtuzumab and Rituximab
Description	Toxicity data will be collected at visits during 18 weeks of treatment and include adverse events considered at least possibly related to either study drugs (Alemtuzumab and Rituximab) and graded 3-5 using CTCAE 3.0. In general grading is as follows: Grade 1=mild Grade 2=moderate Grade 3=severe Grade 4=life threatening Grade 5=death Reported below are the number of patients who experienced each event
Time Frame	During treatment, 18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Measure Participants	30
Neutropenia	9 30%
Thrombocytopenia	2 6.7%
Infection	2 6.7%
Renal toxicity	1 3.3%
Skin rash	1 3.3%
Fatigue	1 3.3%

4. Post-Hoc Outcome

Title	Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Lymphadenopathy and Organomegaly Measured During Physical Examination
Description	Patients best response to treatment as defined in general as: Complete Remission=Absence of lymphadenopathy and constitutional symptoms, Normal CBC, peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with < 30% of nucleated cells being lymphocytes. Partial Remission=absence of constitutional symptoms, ≥50%decrease in peripheral blood lymphocyte count, ≥50%reduction in lymphadenopathy, ≥50%reduction in liver and/or spleen size & 1 of the following: polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline, platelets >100,000/μl or 50%improvement over baseline, hemoglobin > 11.0 gm/dl or 50% improvement over baseline without transfusions. Stable Disease=Do not meet criteria for complete/partial remission or progressive disease. Progressive Disease= ≥50%increase ≥2 lymph nodes or ≥50% increase in absolute no. of circulating lymphocytes or ≥50% increase in liver and/or spleen size or transformation to a more aggressive histology
Time Frame	At week 9, and post 18 weeks of treatment, then every 3 months for a year and up every 6 months for up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Measure Participants	30
Complete Remission	18 60%
Partial Remission	12 40%
Stable Disease	0 0%
Progressive Disease	0 0%

5. Post-Hoc Outcome

Title	Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans
Description	Best Response to treatment, in general is defined as: Complete Remission= absence of significant lymphadenopathy and no hepatomegaly/splenomegaly. Partial Remission=reduction in lymphadenopathy as defined by the following: (a) 50% decrease in lymph node size by 50% either in the sum products of up to six lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy; (b) no increase in any lymph node, and no new enlarged lymph node; in small lymph nodes (<2cm),and a reduction in the noted pretreatment enlargement of the spleen or liver by 50% or more. Stable Disease=not meet criteria for complete/partial remission or progressive disease Progressive Disease=appearance of any new lesion, such as enlarged lymph nodes (1.5cm), splenomegaly, hepatomegaly or other organ infiltrates: (a)50%increase + in greatest diameter of any previous site; (b)50% + increase liver or spleen size.
Time Frame	At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Measure Participants	30
Complete Remission	7 23.3%
Partial Remission	14 46.7%
Stable Disease	9 30%
Progressive Disease	0 0%

Adverse Events

Time Frame	Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Arm/Group Title	Alemtuzumab and Rituximab
Arm/Group Description	Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
All Cause Mortality
	Alemtuzumab and Rituximab
	Affected / at Risk (%)	# Events
Total	4/30 (13.3%)
Serious Adverse Events
	Alemtuzumab and Rituximab
	Affected / at Risk (%)	# Events
Total	11/30 (36.7%)
Infections and infestations
Possible infection with fever	2/30 (6.7%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelogenous leukemia	1/30 (3.3%)	1
Diffuse large B cell lymphoma	3/30 (10%)	3
Multiple myeoma	1/30 (3.3%)	1
Urachal adenocarcinoma of the bladder	1/30 (3.3%)	1
Esophageal cancer	1/30 (3.3%)	1
Colon Cancer	1/30 (3.3%)	1
Renal and urinary disorders
Possible acute renal failure	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Alemtuzumab and Rituximab
	Affected / at Risk (%)	# Events
Total	30/30 (100%)
Blood and lymphatic system disorders
Hemoglobin (anemia)	24/30 (80%)
Neutrophils (neutropenia)	18/30 (60%)
Leukocytes (total WBC)	29/30 (96.7%)
Lymphopenia	30/30 (100%)
Platelets (thrombocytopenia)	19/30 (63.3%)
Edema	1/30 (3.3%)
:Edema:trunk/genital	1/30 (3.3%)
Cardiac disorders
Hypotension	2/30 (6.7%)
Atrial fibrillation	1/30 (3.3%)
Tachycardia	1/30 (3.3%)
Ear and labyrinth disorders
Ear pressure/pain	1/30 (3.3%)
Pain : ear	1/30 (3.3%)
Endocrine disorders
Hot flashes/flushes	4/30 (13.3%)
Eye disorders
Flashing lights	1/30 (3.3%)
Watery eye (epiphora, tearing)	1/30 (3.3%)
Gastrointestinal disorders
Anorexia	3/30 (10%)
Constipation	2/30 (6.7%)
Colitis	1/30 (3.3%)
Diarrhea	3/30 (10%)
Flatulence	1/30 (3.3%)
Mucositis/stomatitis	1/30 (3.3%)
Heartburn/dyspepsia	1/30 (3.3%)
Nausea	5/30 (16.7%)
Dry lips	2/30 (6.7%)
Taste alteration(dysgeusia)	2/30 (6.7%)
Vomiting	2/30 (6.7%)
Scratchy throat	3/30 (10%)
Dysphagia (difficulty swallowing)	1/30 (3.3%)
Abdomen pain NOS	1/30 (3.3%)
General disorders
Allergic rhinitis (including sneezing,nasal stuffiness,postnasal drip)	1/30 (3.3%)
Malaise	2/30 (6.7%)
Fatigue	12/30 (40%)
Fever	15/30 (50%)
Insomnia	3/30 (10%)
Rigors	4/30 (13.3%)
Chills	4/30 (13.3%)
Sweating	13/30 (43.3%)
Weight loss	9/30 (30%)
Shaking	1/30 (3.3%)
Hematuria	1/30 (3.3%)
GENERAL- Pain	11/30 (36.7%)
Flu-like syndrome	4/30 (13.3%)
Nasal drip	1/30 (3.3%)
Nasal congestion	1/30 (3.3%)
Infections and infestations
Upper respiratory infection	1/30 (3.3%)
Lung (pneumonia)	1/30 (3.3%)
Upper airway infection NOS	1/30 (3.3%)
Adenovirus	1/30 (3.3%)
NOS	2/30 (6.7%)
CMV positive	5/30 (16.7%)
Metabolism and nutrition disorders
Alkaline phosphatase	9/30 (30%)
Transaminase	11/30 (36.7%)
Bicarbinate high	1/30 (3.3%)
High GFR	2/30 (6.7%)
ALT, SGPT (serum glutamic pyruvic transaminase)high	4/30 (13.3%)
AST, SGOT (serum glutamic oxaloacetic transaminase) high	5/30 (16.7%)
Albumin, serum-low (hypoalbuminemia)	14/30 (46.7%)
Bilirubin (hyperbilirubinemia)	3/30 (10%)
High LDH	6/30 (20%)
Increased BUN	1/30 (3.3%)
Creatinine	2/30 (6.7%)
Calcium, serum-low (hypocalcemia)	13/30 (43.3%)
Cholesterol, serum-high (hypercholesteremia)	1/30 (3.3%)
Glucose, serum-high (hyperglycemia)	24/30 (80%)
Glucose, serum-low(hypoglycemia)	4/30 (13.3%)
Magnesium, serum-high (hypermagnesemia)	1/30 (3.3%)
Magnesium, serum-low(hypomagnesemia)	3/30 (10%)
Phosphate, serum-low (hypophosphatemia)	4/30 (13.3%)
Potassium, serum-high(hyperkalemia)	2/30 (6.7%)
Potassium, serum-low(hypokalemia)	4/30 (13.3%)
Sodium, serum-high(hypernatremia)	4/30 (13.3%)
Sodium, serum-low(hyponatremia)	11/30 (36.7%)
Uric acid, serum-high (hyperuricemia)	2/30 (6.7%)
Musculoskeletal and connective tissue disorders
Muscle aches	1/30 (3.3%)
Muscle cramps	1/30 (3.3%)
Leg cramps	1/30 (3.3%)
Nervous system disorders
Neuropathy:sensory	4/30 (13.3%)
Motor - hand tremors	1/30 (3.3%)
Syncope (fainting)	1/30 (3.3%)
Headache	4/30 (13.3%)
Psychiatric disorders
Dizziness	4/30 (13.3%)
Mood alteration - Anxiety	1/30 (3.3%)
Mood alteration - Depression	1/30 (3.3%)
Renal and urinary disorders
Renal failure	1/30 (3.3%)
Polyuria	1/30 (3.3%)
Dysuria	3/30 (10%)
Renal incontinence	1/30 (3.3%)
Renal insufficiency	1/30 (3.3%)
Reproductive system and breast disorders
vaginal burning	1/30 (3.3%)
Respiratory, thoracic and mediastinal disorders
Cough	6/30 (20%)
Dyspnea (shortness of breath)	4/30 (13.3%)
Dyspnea on exertion	1/30 (3.3%)
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes	24/30 (80%)
Pruritus/itching	8/30 (26.7%)
Perivascular neutrophilic dermatitis	1/30 (3.3%)
Rash	12/30 (40%)
Sun burn	1/30 (3.3%)
Skin peeling	1/30 (3.3%)
Bruising	2/30 (6.7%)
Hives	3/30 (10%)
Alopecia	1/30 (3.3%)
Blotchiness	1/30 (3.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.