Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy

• Sponsor: Spectrum Pharmaceuticals, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01510184
• Collaborator: (none)
• Enrollment: 79
• Locations: 93
• Arms: 2
• Actual Duration (Months): 30.1
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma; Follicle Center Lymphoma	Drug: Zevalin; Drug: Y-90-Zevalin; Drug: Rituximab; Drug: In-111 Zevalin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) Versus Observation in Patients at Least 60 Years of Age With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy
• Actual Study Start Date: Apr 19, 2012
• Actual Primary Completion Date: Oct 23, 2014
• Actual Study Completion Date: Oct 23, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zevalin Participants received rituximab 250 milligram per meter square (mg/m^2) by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 millicurie (mCi) on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/ microliter [μL] to 149,000/μL).	Drug: Zevalin; Zevalin administered intravenous infusion.; Other Names: Ibritumomab Tiuxetan ; Drug: Y-90-Zevalin; Y-90-Zevalin administered by intravenous infusion.; Drug: Rituximab; Rituximab administered by intravenous infusion.; Drug: In-111 Zevalin; In-111-Zevalin administered by intravenously.
No Intervention: Observation Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease.

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) for Living Participants [From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)]

   OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.

2. Overall Survival for Death [From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)]

   OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.

Secondary Outcome Measures

1. Progression-Free Survival (PFS) [From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)]

   PFS was defined as the time interval between the date of randomization and the date of relapse or death from any cause.

2. Overall Survival Rate at 24 Months [24 Months]

   The OS rate at 24-month defined as the percentage of all randomized participants who died within 24 months of randomization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participant was 60-years of age or older at time of randomization

2. Histologically confirmed Ann Arbor stage II, III, or IV diffuse large B-cell lymphoma (DLBCL); or follicular lymphoma (FCL) Grade 3B according to the Revised European American lymphoma (REAL)/ World health organization (WHO) classification (from initial diagnosis made prior to starting R-CHOP therapy. Results from a pre R-CHOP marrow shall be available for review.

3. Local pathology review confirming the DLBCL diagnosis and cluster of differentiation 20 (CD20) positivity, and no evidence of DLBCL in bone marrow upon confirmation of complete remission (CR).

4. A paraffin block or original slides available for confirmatory pathology review. Participants may be randomized based on the local pathology result.

5. Age-adjusted international prognostic index (IPI) of 1, 2, or 3. The age-adjusted IPI was defined by one point for Lactate dehydrogenase (LDH) > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ eastern cooperative operations group (ECOG) performance status >1.

6. First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) chemotherapy. Participants who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible.

7. Complete remission (CR) according to the International Workshop Response Criteria for non-Hodgkin's lymphoma (NHL) described by Cheson et al after first-line treatment. Computerized tomography (CT) scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of chemotherapy. Applicability of the neck CT means that the participant had involvement of the neck region by palpation / physical examination at first diagnosis.

8. A negative Fluorine-18-deoxyglucose positron emission tomography (FDG-PET) scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735).

9. Bone marrow cellularity greater than 15%, no evidence of myelodysplasia morphologically and no evidence of involvement with lymphoma either at the pre R-CHOP marrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeat marrow is required for participant randomized to the Zevalin arm only.

10. A world health organization/eastern cooperative oncology group (WHO/ECOG) performance status of 0, 1 or 2.

11. Adequate hematopoietic functions: Absolute neutrophil count (ANC) ≥ 1.0 x 10^{9/ liter (L), Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 10}9/L.

12. Life expectancy of 6 months or longer.

13. Written informed consent obtained according to local guidelines.

Exclusion Criteria:

1. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, participants treated for Stage I or II cancers are eligible provided they have a life expectancy of > 5 years. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.

2. Prior radioimmunotherapy, including radiation therapy for Non-Hodgkin's lymphoma) NHL, or any other NHL therapy.

3. Presence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis.

4. Histological transformation of low-grade NHL.

5. Active hepatitis B or C.

6. Known history of human immunodeficiency virus (HIV) infection.

7. Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease.

8. Abnormal renal function: serum creatinine > 2.0 × ULN.

9. Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment.

10. Known hypersensitivity to murine or chimeric antibodies or proteins.

11. Granulocyte-colony stimulating factor (G-CSF) or Granulocyte macrophage-colony stimulating factor (GM-CSF) therapy within 4 weeks prior to Zevalin or observation.

12. Concurrent severe and/or medically uncontrolled disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study.

13. Treatment with investigational drugs less than 4 weeks prior to Zevalin or observation.

14. Major surgery less than 4 weeks prior to Zevalin or start of observation.

15. Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment. Participants on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20 milligram (mg) daily, stable for 4 weeks, are permissible.

16. Unwillingness or inability to comply with the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Treatment Services Arizona	Casa Grande	Arizona	United States	85122
2	Sutter East Bay Hospitals	Berkeley	California	United States	94704
3	City of Hope	Duarte	California	United States	91010
4	Halifax Health Medical Center	Daytona Beach	Florida	United States	32114
5	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33612
6	Piedmont Hospital Cancer Center	Atlanta	Georgia	United States	30318
7	St. Luke's Mountain States Tumor Institute (MSTI)	Boise	Idaho	United States	83712
8	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
9	Rush University Medical Center	Chicago	Illinois	United States	60612
10	Decatur Memorial Hospital Cancer Care Specialists of Central Illinois	Decatur	Illinois	United States	62526
11	Illinois Cancer Specialists	Niles	Illinois	United States	60714
12	Midwestern Regional Medical Center	Zion	Illinois	United States	60099
13	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
14	Norton Cancer Institute, Suburban	Louisville	Kentucky	United States	40207
15	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
16	St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
17	Oncology Research-Park Nicollet Institute	Saint Louis Park	Minnesota	United States	55426
18	Saint Louis University	Saint Louis	Missouri	United States	63110
19	Comprehensive Cancer Centers of Nevada	Henderson	Nevada	United States	89044
20	Hackensack UMC / John Theurer Cancer Center	Hackensack	New Jersey	United States	07601
21	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
22	Adams Cancer center	Gettysburg	Pennsylvania	United States	17325
23	York Cancer Center / Cancer Care Associates of York	York	Pennsylvania	United States	17403
24	Saint Francis Hospital	Greenville	South Carolina	United States	29601
25	Avera Hematology and Transplant	Sioux Falls	South Dakota	United States	57105
26	Associates In Oncology and Hematology	Chattanooga	Tennessee	United States	37421
27	The University of Texas M.D. Anderson Cancer Center	Houston	Texas	United States	77030
28	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
29	Royal Hobart Hospital	Hobart	Tasmania	Australia	7001
30	Royal Melbourne	Parkville	Victoria	Australia	3052
31	Royal Adelaide Hospital	Adelaide		Australia
32	Barwon Health	Geelong		Australia	3220
33	Western Hospital	Melbourne		Australia
34	Medizinische Universität Wien -AKH Wien	Vienna		Austria	A-1090
35	Nuclear Medicine Physician, Jules Bordet Institute	Bruxelles		Belgium	1000
36	University Hospital Gasthuisberg	Leuven		Belgium	3000
37	Thunder Bay Regional Health Sciences Centre-Regional Cancer Care	Thunder Bay	Ontario	Canada	P7B 6V4
38	Sunnybrook Research Institute	Toronto	Ontario	Canada
39	CSSS Champlain Charles LeMoyne	Greenfield Park	Quebec	Canada	J4V2H1
40	CHU A Michallon	Grenoble	Cedex 9	France	38043
41	CHU Dupuytren	Limoges	Cedex	France	87042
42	CHU Amiens, Hôpital Sud	Amiens		France	80054
43	CH Avignon	Avignon		France	84902
44	CH de la Côte Basque, Service d'Hématologie	Bayonne		France	64109
45	Hématologie - CHU Jean Minjoz	Besancon		France	25030
46	Institut Bergonié	Bordeaux		France	33076
47	Hopital MORVAN - CHU Brest	Brest		France	29609
48	Centre François Baclesse, Comite Hématologie	Caen		France	14076
49	Hôpital Henri MONDOR	Creteil		France	94010
50	CHD Vendée	La Roche-sur-Yon		France	85925
51	CHRU Lille- Hospital Claude Huriez	Lille		France	59037
52	Institut Paoli-Calmettes	Marseille		France	13273
53	CHR Metz-Thionville	Metz		France	57085
54	CH de Mulhouse - Hôpital Emile Muller	Mulhouse		France	68100
55	Centre Antoine Lacassagne	Nice		France	06189
56	CHR Orléans	Orleans		France	45100
57	Institut Curie	Paris		France	75005
58	Centre Hospitalier Saint Jean	Perpignan		France	66000
59	Hôpital Haut-Levêque Centre F.Magendie	Pessac		France	33600
60	Centre Hospitalier René Dubos,	Pontoise		France	95303
61	Service d'Hématologie Centre Henri Becquerel	Rouen		France	76038
62	CHU de Brabios	Vandoeuvre-les-nancy		France	54511
63	St James 's Hospital	Dublin		Ireland	8
64	University Hospital Galway	Galway		Ireland
65	Soroka Medical Centre	Beersheba		Israel	84101
66	Rambam Health Care Campus	Haifa		Israel
67	Hadassah Medical Organization	Jerusalem		Israel	91120
68	Shaare Zedek Medical Center	Jerusalem		Israel	93722
69	Tel Aviv Sourasky Medical Centre	Tel Aviv		Israel	64239
70	Chaim Sheba Medical Center	Tel-Hashomer		Israel	52621
71	Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli''	Bologna		Italy	40138
72	New Ematologia dell'Ospedale "Spedali Civili" di Brescia	Brescia		Italy	25123
73	Divisione di Ematoncologia	Milano		Italy	20141
74	Azienda Ospedaliera Sant'Andrea	Roma		Italy	00189
75	Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette,	Torino		Italy	10126
76	Meander Medisch Centrum	Amersfoort		Netherlands	3813 TZ
77	VU Medisch Centrum	Amsterdam		Netherlands	1081
78	Haga Ziekenhuis	Den Haag		Netherlands	2545 CH
79	University Medical Centre Groningen (UMCG)	Groningen		Netherlands	9713GZ
80	Spaarne Ziekenhuis, Internal Medicine/Ocology	Hoofddorp		Netherlands	2134TM
81	Medisch Centrum Leeuwarden	Leeuwarden		Netherlands	8934 AD
82	St. Antonius Hospital	Nieuwegein		Netherlands	3435 CM
83	University Medical Center Radboud Nijmegen	Nijmegen		Netherlands	6525
84	Erasmus Medisch Centrum	Rotterdam		Netherlands	NL-3015
85	Auxilio Mutuo Cancer Center	San Juan		Puerto Rico	00918
86	Clínica Universidad de Navarra (CUN)	Pamplona		Spain
87	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009
88	Miguel Servet University Hospital	Zaragoza		Spain
89	Department of Haematology Bristol Royal Infirmary	Bristol		United Kingdom	BS2 8HW
90	Poole General Hospital	Dorset		United Kingdom	BH15
91	Beatson Cancer Centre	Glasgow		United Kingdom	G12 0YN
92	King's College Hospital	London		United Kingdom	SE5 9RS
93	The Christie NHS Foundation Trust, The Christie Hospital,	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• Spectrum Pharmaceuticals, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spectrum Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01510184
• Other Study ID Numbers: SPI-ZEV-11-301
• First Posted: Jan 13, 2012
• Last Update Posted: Dec 16, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Rituximab; Antibodies, Monoclonal

Study Results

Participant Flow

Recruitment Details	A total of 79 participants were enrolled into the study from 19 Apr 2012 to 23 Oct 2014.

Arm/Group Title	Zevalin	Observation
Arm/Group Description	Participants received rituximab 250 milligram per meter square (mg/m^2) by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 millicurie (mCi) on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/ microliter [μL] to 149,000/μL).	Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
Period Title: Overall Study
STARTED	36	43
COMPLETED	6	8
NOT COMPLETED	30	35

Baseline Characteristics

Arm/Group Title	Zevalin	Observation	Total
Arm/Group Description	Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).	Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease	Total of all reporting groups
Overall Participants	36	43	79
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (1.02)	71 (1.06)	70 (0.75)
Sex: Female, Male (Count of Participants)
Female	20 55.6%	22 51.2%	42 53.2%
Male	16 44.4%	21 48.8%	37 46.8%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS) for Living Participants
Description	OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.
Time Frame	From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment. Overall number of participants analyzed signifies participants who were alive.

Arm/Group Title	Zevalin	Observation
Arm/Group Description	Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).	Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
Measure Participants	35	41
Median (Full Range) [months]	8.90	6.14

2. Primary Outcome

Title	Overall Survival for Death
Description	OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.
Time Frame	From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment. Overall number of participants analyzed signifies participants who died.

Arm/Group Title	Zevalin	Observation
Arm/Group Description	Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).	Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
Measure Participants	1	2
Median (Full Range) [months]	16.76	5.82

3. Secondary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS was defined as the time interval between the date of randomization and the date of relapse or death from any cause.
Time Frame	From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)

Outcome Measure Data

Analysis Population Description

Data for this outcome measure was not collected and analyzed due to early termination of study for sponsor business decision.

Arm/Group Title	Zevalin	Observation
Arm/Group Description	Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).	Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
Measure Participants	0	0

4. Secondary Outcome

Title	Overall Survival Rate at 24 Months
Description	The OS rate at 24-month defined as the percentage of all randomized participants who died within 24 months of randomization.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Data for this outcome measure was not collected and analyzed due to early termination of study for sponsor business decision.

Arm/Group Title	Zevalin	Observation
Arm/Group Description	Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).	Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
Measure Participants	0	0

Adverse Events

Time Frame	From first dose up to approximately 2.5 years
Adverse Event Reporting Description	Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.
Arm/Group Title	Zevalin		Observation
Arm/Group Description	Participants received rituximab 250 mg/m^2 by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 mCi on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/μL to 149,000/μL).		Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease
All Cause Mortality
	Zevalin		Observation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)		2/43 (4.7%)
Serious Adverse Events
	Zevalin		Observation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/36 (22.2%)		3/43 (7%)
Blood and lymphatic system disorders
Neutropenia	4/36 (11.1%)		1/43 (2.3%)
Thrombocytopenia	2/36 (5.6%)		0/43 (0%)
Leukopenia	1/36 (2.8%)		0/43 (0%)
General disorders
Death	0/36 (0%)		2/43 (4.7%)
Infections and infestations
Lung infection	1/36 (2.8%)		0/43 (0%)
Investigations
Platelet count decreased	2/36 (5.6%)		0/43 (0%)
Lymphocyte count decreased	1/36 (2.8%)		0/43 (0%)
Nervous system disorders
Syncope	1/36 (2.8%)		0/43 (0%)
Depressed level of consciousness	0/36 (0%)		1/43 (2.3%)
Vascular disorders
Hypotension	1/36 (2.8%)		0/43 (0%)
Embolism	0/36 (0%)		1/43 (2.3%)
Other (Not Including Serious) Adverse Events
	Zevalin		Observation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/36 (58.3%)		7/43 (16.3%)
Blood and lymphatic system disorders
Thrombocytopenia	6/36 (16.7%)		0/43 (0%)
Neutropenia	6/36 (16.7%)		1/43 (2.3%)
Anaemia	5/36 (13.9%)		0/43 (0%)
Gastrointestinal disorders
Constipation	5/36 (13.9%)		0/43 (0%)
Nausea	4/36 (11.1%)		1/43 (2.3%)
Diarrhoea	3/36 (8.3%)		3/43 (7%)
Vomiting	2/36 (5.6%)		0/43 (0%)
General disorders
Fatigue	10/36 (27.8%)		2/43 (4.7%)
Investigations
Platelet count decreased	6/36 (16.7%)		0/43 (0%)
Neutrophil count decreased	6/36 (16.7%)		0/43 (0%)
White blood cell count decreased	6/36 (16.7%)		0/43 (0%)
Lymphocyte count decreased	4/36 (11.1%)		0/43 (0%)
Musculoskeletal and connective tissue disorders
Back pain	3/36 (8.3%)		0/43 (0%)
Pain in extremity	2/36 (5.6%)		2/43 (4.7%)
Nervous system disorders
Headache	3/36 (8.3%)		0/43 (0%)
Dizziness	2/36 (5.6%)		1/43 (2.3%)
Dysgeusia	2/36 (5.6%)		0/43 (0%)
Neuropathy peripheral	0/36 (0%)		3/43 (7%)
Respiratory, thoracic and mediastinal disorders
Cough	3/36 (8.3%)		0/43 (0%)
Skin and subcutaneous tissue disorders
Pruritus	2/36 (5.6%)		0/43 (0%)

Limitations/Caveats

The study was terminated early due to a sponsor business decision.

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.