Azacitidine and Lintuzumab in Treating Patients With Previously Untreated Myelodysplastic Syndromes

• Sponsor: Alison Walker (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00997243
• Collaborator: Seagen Inc. (Industry)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as lintuzumab, 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 chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying the side effects and how well giving azacitidine together with lintuzumab works in treating patients with previously untreated myelodysplastic syndromes.

Condition or Disease	Intervention/Treatment	Phase
Leukemia; Myelodysplastic Syndromes	Biological: lintuzumab; Drug: 5-azacytidine	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To determine the complete response rate of the combination of lintuzumab and azacitidine in patients with myelodysplastic syndromes.

Secondary

• To define the specific toxicities of this regimen.

• To determine the overall response rate.

• To determine the relationship between pretreatment expression of Syk and clinical response.

• To determine whether the investigational agents modulate Syk expression and to correlate drug-induced changes in Syk with response to treatment.

• To provide preliminary data on the biological activity of azacitidine as a demethylating agent (changes in target gene methylation and gene expression, DNMT1 protein expression, global methylation).

• To perform exploratory studies of azacitidine-triphosphate with global DNA methylation.

• To explore the biologic role of microRNA in determining clinical response to this regimen and achievement of the other pharmacodynamic endpoints.

OUTLINE: Patients receive azacitidine IV or subcutaneously once daily on days 1-7 and lintuzumab IV on days 2, 7, 15, and 22 (days 2 and 15 of course 1 only). Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

Blood and bone marrow samples are collected periodically for pharmacodynamic studies.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of 5-azacytidine and Lintuzumab in Myelodysplastic Syndromes (MDS)
• Actual Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 5-azacytidine and Lintuzumab Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC(subcutaneous)daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.

Biological: lintuzumab; Cycle 1 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22. Subsequent Cycles (cycles to be repeated every 28 days) 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy. Doses should be given at least 12 days apart. By convention, dosing on days 7 and 22 of each cycle will be encouraged, but due to expected issues of patient convenience (time, travel, etc.), the study requirements are every other week, twice during each cycle, with one dose during AZA treatment.; Other Names: SGN-33 ; Drug: 5-azacytidine; 75mg/m2 IV/SC daily on days 1-7.; Other Names: Vidaza AZA

Outcome Measures

Primary Outcome Measures

1. Complete Response Rate [up to 5 years]

   Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.

Secondary Outcome Measures

1. Overall Response Rate [up to 5 years]

   Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.

2. Toxicities of the Combination [up to 5 years]

   All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.

3. Determine the Relationship Between Pretreatment Expression of Syk and Clinical Response; to Determine Whether the Investigational Agents Modulate Syk Expression and Correlate Drug-induced Changes in Syk With Response to Treatment [up to 5 years]

4. Provide Preliminary Data on the Biological Activity of AZA as a Demethylating Agent (Changes in Target Gene Methylation and Gene Expression, DNMT1[Deoxyribonucleic Acid Methyltransferase 1 DNA Methyltransferase 1]Protein Expression, Global Methylation) [up to 5 years]

5. Perform Exploratory Studies of AZA-triphosphate With Global DNA Methylation [up to 5 years]

6. Explore the Biologic Role of microRNAs in Determining Clinical Response to the AZA Plus Lintuzumab Combination and Achievement of the Other Pharmacodynamic Endpoints [Up to 5 years]

Eligibility Criteria

Criteria

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

Eligibility Criteria:

• Age >18 with untreated MDS by FAB or WHO criteria (note: FAB criteria for MDS includes <29% blasts; FAB criteria includes CMML).

• Patients with therapy related disease (t-MDS).

• If the patient has co-morbid medical illness, life expectancy attributed to this must be greater than 6 months.

• Eastern Cooperative Oncology Group (ECOG) performance status <2.

• Must have adequate organ function as defined below:

• total bilirubin <2.0mg/dL

• AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

• creatinine <2.0mg/dL

• NYHA CHF(congestive heart failure)Class II or better

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).

• Ability to understand and willingness to sign the written informed consent document.

• CD33 expression is required on at least 25% of left shifted dysplastic myeloid cells, including blasts. This testing will be done on bone marrow aspirate, but for patients whose CD33 expression in this cellular compartment cannot be ascertained, peripheral blood will be allowed to determine this.

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 6 months (for other cancers) prior to entering the study.

• Patients receiving any other investigational agents or patients that have received other investigational agents within 1 month of enrollment.

• Patients with active central nervous system disease or with granulocytic sarcoma as sole site of disease.

• Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZA or lintuzumab that are not easily managed are excluded. Patients with hypersensitivity to mannitol are excluded.

• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. As infection is a common feature of MDS, patients with active infection are permitted to enroll provided that the infection is under control. Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

• Psychiatric conditions that prevent compliance with protocol or consent.

• Pregnant women or women who are breastfeeding are excluded from this study.

• HIV-positive patients on combination antiretroviral therapy are ineligible.

• Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study.

• Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study.

• Patients with baseline fibrinogen <100mg/dL, or those with clinically significant disseminated intravascular coagulation, are excluded.

• Patients who require ongoing therapeutic anticoagulation with warfarin, lovenox, or similar agent are excluded. This does not apply to patients on low dose prophylaxis therapy.

• Patients who require ongoing clopidogrel therapy are excluded. In cases where clopidogrel use at screening is subsequently discontinued due to ongoing or future risk of drug and treatment related cytopenias, such patients will be eligible.

• Patients with platelet <10,000/uL who are refractory to platelet transfusion are not eligible (must bump to at least >10,000/uL after transfusion)

• Patients who have previously received lenalidomide or thalidomide are excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Alison Walker
• Seagen Inc.

Investigators

• Principal Investigator: Alison Walker, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Jamesline

Publications

None provided.

• Responsible Party: Alison Walker, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00997243
• Other Study ID Numbers: OSU-09034; NCI-2011-03159
• First Posted: Oct 19, 2009
• Last Update Posted: May 10, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Alison Walker, Principal Investigator, Ohio State University Comprehensive Cancer Center: de novo myelodysplastic syndromes; secondary myelodysplastic syndromes; chronic myelomonocytic leukemia; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; refractory anemia with ringed sideroblasts; refractory anemia; refractory cytopenia with multilineage dysplasia
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome; Azacitidine; Lintuzumab

Study Results

Participant Flow

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Period Title: Overall Study
STARTED	7
COMPLETED	0
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	75 mg/m2 5-azacytidine (Vidaza, AZA) and 600 mg Lintuzumab
Arm/Group Description	5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7 cycle 1 and all subsequent cycles. Lintuzumab 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22 for cycle 1 and 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy for all other subsequent cycles.
Overall Participants	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 28.6%
>=65 years	5 71.4%
Sex: Female, Male (Count of Participants)
Female	1 14.3%
Male	6 85.7%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Complete Response Rate
Description	Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Measure Participants	7
Number [percentage of participants]	14 200%

2. Secondary Outcome

Title	Overall Response Rate
Description	Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Measure Participants	7
Number [percentage of participants]	14 200%

3. Secondary Outcome

Title	Toxicities of the Combination
Description	All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Measure Participants	7
Thrombosis/embolism (vascular access-related)	14 200%
Platelets	100 1428.6%
Neutrophils/granulocytes (ANC/AGC)	100 1428.6%
Lymphopenia	57 814.3%
Leukocytes (total WBC)	100 1428.6%
Infection with unknown ANC - Upper airway NOS	14 200%
Infection with normal ANC or Grade 1 or 2 neutroph	14 200%
Infection with unknown ANC - Bladder (urinary)	14 200%
Infection	28 400%
Infection Grade 3 or 4 neutrophils-blood	28 400%
Hemorrhage, GI (lower GI NOS/Rectum)	14 200%
Hemorrhage/Bleeding - Other	14 200%
Hemoglobin	100 1428.6%
Fever (in the absence of neutropenia)	28 400%
Febrile neutropenia (fever of unknown origin)	14 200%

4. Secondary Outcome

Title	Determine the Relationship Between Pretreatment Expression of Syk and Clinical Response; to Determine Whether the Investigational Agents Modulate Syk Expression and Correlate Drug-induced Changes in Syk With Response to Treatment
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

No participants were analyzed due to withdrawal of the investigational agent by the company.

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Measure Participants	0

5. Secondary Outcome

Title	Provide Preliminary Data on the Biological Activity of AZA as a Demethylating Agent (Changes in Target Gene Methylation and Gene Expression, DNMT1[Deoxyribonucleic Acid Methyltransferase 1 DNA Methyltransferase 1]Protein Expression, Global Methylation)
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

No participants were analyzed due to withdrawal of the investigational agent by the company.

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Measure Participants	0

6. Secondary Outcome

Title	Perform Exploratory Studies of AZA-triphosphate With Global DNA Methylation
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

No participants were analyzed due to withdrawal of the investigational agent by the company.

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Measure Participants	0

7. Secondary Outcome

Title	Explore the Biologic Role of microRNAs in Determining Clinical Response to the AZA Plus Lintuzumab Combination and Achievement of the Other Pharmacodynamic Endpoints
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

No participants were analyzed due to withdrawal of the investigational agent by the company.

Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Measure Participants	0

Adverse Events

Time Frame	Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Arm/Group Title	5-azacytidine and Lintuzumab
Arm/Group Description	Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
All Cause Mortality
	5-azacytidine and Lintuzumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	5-azacytidine and Lintuzumab
	Affected / at Risk (%)	# Events
Total	7/7 (100%)
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	1/7 (14.3%)	2
Hemoglobin	1/7 (14.3%)	1
Cardiac disorders
Pain - Cardiac/heart	1/7 (14.3%)	1
Palpitations	2/7 (28.6%)	2
Supraventricular and nodal arrhythmia - Sinus tachycardia	3/7 (42.9%)	5
Supraventricular and nodal arrhythmia - Supraventricular tachycardia	1/7 (14.3%)	1
Eye disorders
Vision-blurred vision	1/7 (14.3%)	1
Vision-flashing lights/floaters	1/7 (14.3%)	1
Gastrointestinal disorders
Constipation	1/7 (14.3%)	2
Distension/bloating, abdominal	2/7 (28.6%)	3
Hemorrhage, GI - Lower GI NOS	1/7 (14.3%)	1
Nausea	2/7 (28.6%)	2
Pain - Abdomen NOS	2/7 (28.6%)	2
Vomiting	2/7 (28.6%)	2
General disorders
Edema: limb	2/7 (28.6%)	2
Fatigue (asthenia, lethargy, malaise)	4/7 (57.1%)	5
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	2/7 (28.6%)	3
Pain - Chest/thorax NOS	2/7 (28.6%)	2
Rigors/chills	3/7 (42.9%)	4
Syndromes - Other (Specify, __)	1/7 (14.3%)	1
Hepatobiliary disorders
Cystitis	1/7 (14.3%)	1
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	1/7 (14.3%)	1
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	1/7 (14.3%)	1
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	1/7 (14.3%)	1
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	1/7 (14.3%)	1
Infection with unknown ANC - Bladder (urinary)	1/7 (14.3%)	1
Investigations
Bilirubin (hyperbilirubinemia)	1/7 (14.3%)	1
Leukocytes (total WBC)	1/7 (14.3%)	1
Neutrophils/granulocytes (ANC/AGC)	3/7 (42.9%)	3
Platelets	1/7 (14.3%)	1
Metabolism and nutrition disorders
Acidosis	1/7 (14.3%)	1
Albumin, serum-low (hypoalbuminemia)	1/7 (14.3%)	1
ALT, SGPT (serum glutamic pyruvic transaminase)	1/7 (14.3%)	1
Anorexia	4/7 (57.1%)	4
AST, SGOT(serum glutamic oxaloacetic transaminase)	1/7 (14.3%)	1
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	2/7 (28.6%)	3
Pain - Back	1/7 (14.3%)	1
Pain - Chest wall	1/7 (14.3%)	1
Pain - Extremity-limb	2/7 (28.6%)	2
Pain - Joint	1/7 (14.3%)	1
Pain - Neck	2/7 (28.6%)	2
Nervous system disorders
Dizziness	2/7 (28.6%)	2
Neurology - Other (Specify, __)	1/7 (14.3%)	1
Pain - Head/headache	2/7 (28.6%)	2
Psychiatric disorders
Confusion	1/7 (14.3%)	1
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS	1/7 (14.3%)	1
Obstruction, GU - Bladder	1/7 (14.3%)	1
Pain - Bladder	1/7 (14.3%)	1
Urinary frequency/urgency	1/7 (14.3%)	1
Urinary retention (including neurogenic bladder)	1/7 (14.3%)	1
Urine color change	2/7 (28.6%)	2
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	1/7 (14.3%)	1
Atelectasis	1/7 (14.3%)	1
Cough	4/7 (57.1%)	4
Dyspnea (shortness of breath)	5/7 (71.4%)	6
Hypoxia	2/7 (28.6%)	2
Pleural effusion (non-malignant)	1/7 (14.3%)	1
Skin and subcutaneous tissue disorders
Dry skin	1/7 (14.3%)	1
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	1/7 (14.3%)	2
Rash/desquamation	1/7 (14.3%)	1
Sweating (diaphoresis)	2/7 (28.6%)	2
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __)	1/7 (14.3%)	1
Hypotension	1/7 (14.3%)	1
Thrombosis/embolism (vascular access-related)	1/7 (14.3%)	1
Other (Not Including Serious) Adverse Events
	5-azacytidine and Lintuzumab
	Affected / at Risk (%)	# Events
Total	7/7 (100%)
Blood and lymphatic system disorders
Hemoglobin	7/7 (100%)	41
Cardiac disorders
Pain - Cardiac/heart	1/7 (14.3%)	2
Palpitations	2/7 (28.6%)	5
Supraventricular and nodal arrhythmia - Sinus tachycardia	3/7 (42.9%)	7
Supraventricular and nodal arrhythmia - Supraventricular tachycardia	1/7 (14.3%)	2
Eye disorders
Ocular/Visual - Other (Specify, __)	1/7 (14.3%)	1
Pain - Eye	1/7 (14.3%)	5
Vision-blurred vision	1/7 (14.3%)	3
Watery eye (epiphora, tearing)	1/7 (14.3%)	2
Keratitis (corneal inflammation/corneal ulceration)	2/7 (28.6%)	2
Gastrointestinal disorders
Anorexia	3/7 (42.9%)	7
Constipation	7/7 (100%)	29
Diarrhea	4/7 (57.1%)	17
Distension/bloating, abdominal	1/7 (14.3%)	1
Hemorrhage, GI - Lower GI NOS	1/7 (14.3%)	3
Incontinence, anal	1/7 (14.3%)	4
Nausea	5/7 (71.4%)	33
Pain - Abdomen NOS	2/7 (28.6%)	4
Pain - Rectum	1/7 (14.3%)	9
Salivary gland changes/saliva	1/7 (14.3%)	2
Vomiting	3/7 (42.9%)	10
General disorders
Constitutional Symptoms - Other (Specify, __)	1/7 (14.3%)	3
Edema: head and neck	1/7 (14.3%)	2
Edema: limb	4/7 (57.1%)	33
Fatigue (asthenia, lethargy, malaise)	7/7 (100%)	52
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	2/7 (28.6%)	4
Pain - Chest/thorax NOS	1/7 (14.3%)	2
Pain - Other (Specify, __)	4/7 (57.1%)	23
Pain - Pain NOS	2/7 (28.6%)	10
Rigors/chills	4/7 (57.1%)	14
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)	1/7 (14.3%)	7
Cytokine release syndrome/acute infusion reaction	1/7 (14.3%)	1
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	1/7 (14.3%)	1
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	2/7 (28.6%)	7
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	1/7 (14.3%)	3
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	1/7 (14.3%)	2
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	1/7 (14.3%)	1
Infection with unknown ANC - Upper airway NOS	1/7 (14.3%)	2
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)	1/7 (14.3%)	3
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	1/7 (14.3%)	3
AST, SGOT(serum glutamic oxaloacetic transaminase)	2/7 (28.6%)	3
Bilirubin (hyperbilirubinemia)	3/7 (42.9%)	8
INR (International Normalized Ratio of prothrombin time)	1/7 (14.3%)	1
Leukocytes (total WBC)	7/7 (100%)	31
Lymphopenia	4/7 (57.1%)	23
Neutrophils/granulocytes (ANC/AGC)	7/7 (100%)	33
Platelets	7/7 (100%)	48
PTT (Partial Thromboplastin Time)	1/7 (14.3%)	1
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	4/7 (57.1%)	11
Glucose, serum-high (hyperglycemia)	4/7 (57.1%)	5
Phosphate, serum-low (hypophosphatemia)	2/7 (28.6%)	7
Potassium, serum-low (hypokalemia)	2/7 (28.6%)	6
Sodium, serum-low (hyponatremia)	4/7 (57.1%)	12
Uric acid, serum-high (hyperuricemia)	1/7 (14.3%)	1
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)	1/7 (14.3%)	7
Muscle weakness, generalized or specific area (not due to neuropathy) - Facial	1/7 (14.3%)	5
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	2/7 (28.6%)	9
Pain - Back	3/7 (42.9%)	15
Pain - Chest wall	1/7 (14.3%)	3
Pain - Extremity-limb	4/7 (57.1%)	17
Pain - Joint	3/7 (42.9%)	16
Pain - Muscle	2/7 (28.6%)	14
Pain - Neck	2/7 (28.6%)	3
Nervous system disorders
Dizziness	3/7 (42.9%)	8
Neurology - Other (Specify, __)	1/7 (14.3%)	2
Neuropathy: sensory	1/7 (14.3%)	5
Pain - Head/headache	4/7 (57.1%)	22
Pain - Sinus	1/7 (14.3%)	2
Syncope (fainting)	1/7 (14.3%)	4
Psychiatric disorders
Insomnia	3/7 (42.9%)	25
Mood alteration - Anxiety	2/7 (28.6%)	20
Mood alteration - Depression	2/7 (28.6%)	13
Renal and urinary disorders
Incontinence, urinary	1/7 (14.3%)	2
Urine color change	2/7 (28.6%)	6
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	2/7 (28.6%)	9
Cough	4/7 (57.1%)	15
Dyspnea (shortness of breath)	7/7 (100%)	37
Hypoxia	1/7 (14.3%)	2
Pain - Throat/pharynx/larynx	1/7 (14.3%)	2
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)	1/7 (14.3%)	4
Dry skin	1/7 (14.3%)	3
Flushing	1/7 (14.3%)	2
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	1/7 (14.3%)	1
Pruritus/itching	1/7 (14.3%)	3
Rash/desquamation	3/7 (42.9%)	13
Sweating (diaphoresis)	3/7 (42.9%)	14
Vascular disorders
Hematoma	1/7 (14.3%)	4
Hemorrhage/Bleeding - Other	1/7 (14.3%)	2
Hot flashes/flushes	1/7 (14.3%)	6
Hypotension	1/7 (14.3%)	2

Limitations/Caveats

The study was terminated early by the sponsor due to the removal of lintuzumab from the market.

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.