Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00329030
• Collaborator: Blood and Marrow Transplant Clinical Trials Network (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 224
• Locations: 36
• Arms: 2
• Duration (Months): 92
• Patients Per Site: 6.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is designed as a Phase III, multicenter trial, comparing progression-free survival (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, B-Cell; Lymphoma, Large-Cell, Immunoblastic; Lymphoma, Non-Hodgkin	Drug: Autologous transplantation using rituxan/BEAM; Drug: Autologous transplantation using Bexxar/BEAM	Phase 3

Detailed Description

BACKGROUND:

Bexxar (Tositumomab and Iodine I 131 Tositumomab) is a radioimmunoconjugate with demonstrated anti-lymphoma effects. This drug is indicated for the treatment of patients with CD20 positive, relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin's lymphoma. Bexxar has been used in several Phase I and II transplant trials either alone or in combination with high-dose chemotherapy for the treatment of relapsed non-Hodgkin's lymphoma. The Phase I and II trials combining Bexxar with BEAM and autologous hematopoietic stem cell transplantation demonstrated promising early results with 80% event-free survival in relapsed chemosensitive diffuse large B-cell non-Hodgkin's lymphoma patients. The administration of Rituxan to the mobilization and conditioning regimen is now the standard of care at most transplant centers. Therefore, the primary endpoint of this study will be to compare progression-free survival after autologous hematopoietic stem cell transplantation for chemotherapy-sensitive diffuse large B-cell lymphoma using Rituxan/BEAM versus Bexxar/BEAM for pre-transplant conditioning.

DESIGN NARRATIVE:

All patients will receive induction or salvage chemotherapy as indicated by their clinical circumstance to achieve at least a partial response (as defined in the protocol). There must be 20% or less bone marrow involvement after their most recent salvage therapy.

Mobilization therapy may be employed per institutional guidelines, but all patients must receive one dose of rituxan (375 mg/m^{2) at least within 4 weeks of actual stem cell apheresis. Patients must have an adequate autograft (target of at least 2.0 X 10}6 CD34+ cells/kg; minimum of more than 1.5 X 106 CD34+ cells/kg) to be eligible for the protocol. Eligible patients will be randomized to receive either: 1) Rituxan plus BEAM, with Rituxan 375 mg/m^{2 IV Days -19 and -12, Carmustine (BCNU) 300 mg/m}2 Day -6, Etoposide 100 mg/m^{2 Days -5 to -2, Cytarabine 100 mg/m}2 Days -5 to -2, and Melphalan 140 mg/m^{2 Day -1 followed by ASCT; or, 2) Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive BCNU 300 mg/m}2 Day -6, Etoposide 100 mg/m^{2 Days -5 to -2, Cytarabine 100 mg/m}2 Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by ASCT.

Patients will be followed for 2 years post-transplant. Survival data, hematopoiesis data, incidence of infection, mucositis assessment data, immune reconstitution data, and toxicity data will be recorded and reported periodically to the BMT CTN Data Coordinating Center (DCC).

Study Design

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Rituxan/BEAM vs. Bexxar/BEAM With Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin's Lymphoma (BMTCTN0401)
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rituxan/BEAM Autologous transplantation using rituxan/BEAM	Drug: Autologous transplantation using rituxan/BEAM; Rituxan 375 mg/m2 (Day -19 and Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation; Other Names: Rituximab
Experimental: Bexxar/BEAM Autologous transplantation using Bexxar/BEAM	Drug: Autologous transplantation using Bexxar/BEAM; Bexxar dosimetric dose 5 mCi (Day -19); Bexxar therapy dose 75 cGy TBD (Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation; Other Names: Tositumomab and Iodine I 131 Tositumomab Bexxar

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) [1 and 2 years]

   Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.

Secondary Outcome Measures

1. Overall Survival [1 and 2 years]

   The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation

2. Incidence of Relapse/Progression [1 and 2 years]

   The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.

3. Complete Response (CR) and Partial Response (PR) Proportion [Day 100 and 2 years]

4. Platelet Recovery to 20,000 Cells/μL [100 and 180 days]

5. Hematologic Function [100 days, 1 year]

   Hematologic function will be defined as ANC > 1,500 neutrophils/μL, hemoglobin > 10 g/dL without transfusion support, and platelet count > 100,000/μL without transfusion support.

6. Incidence of Infection [1 year]

7. Mucositis Severity [Day 21]

   Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.

8. Immune Reconstitution [1 year]

   Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.

9. Immune Reconstitution of Quantitative Immunoglobulins [1 year]

   Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.

10. Treatment-related Mortality (TRM) [1 and 2 years]

    TRM is defined as death occurring in a patient from causes other than relapse or progression

11. Neutrophil Recovery [Day 28 and Day 60]

    Time to neutrophil recovery will be the first of two consecutive days of > 500 neutrophils/μL following the expected nadir.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of persistent or recurrent REAL classification diffuse large B-cell lymphoma, composite lymphoma with more than 50% diffuse large B-cell lymphoma, mediastinal B-cell lymphoma

• Demonstration of CD20+ on at least one histologic specimen

• 18-80 years old at time of first registration

• Three or fewer prior regimens of chemotherapy over the entire course of their disease treatment (including one induction chemotherapy and no more than 2 salvage chemotherapies); monoclonal antibody therapy and involved field radiation therapy will not be counted as prior therapies

• Disease status of primary induction failure, first relapse, or second complete remission; all patients must have chemosensitive disease as demonstrated by response to induction or salvage chemotherapy with at least a partial response (as defined in the protocol)

• No more than a 20% bone marrow involvement

• Patients with adequate organ function as measured by:

• Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; additionally, patients greater than 60 years of age must have a left ventricular ejection fraction at rest of at least 40% demonstrated by Multi-Gated Acquisition Scan (MUGA)

• Hepatic: Bilirubin less than 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) and alanine transaminase (ALT) and aspartate transaminase (AST) less than 3x the upper limit of normal

• Renal: Creatinine less than 2.0 mg/dL or creatinine clearance (calculated creatinine clearance is permitted) more than 40 mL/min; no hydronephrosis on CT scan prior to mobilization

• Pulmonary: Carbon Monoxide Diffusing Capacity (DLCO), Volume forcibly exhaled in one second (FEV1), forced vital capacity (FVC) at least 45% of predicted (corrected for hemoglobin)

• Autologous graft with a minimum of at least 1.5 X 10^{6 CD34+ cells/kg (target greater than 2.0 X 10}6 CD34+ cells/kg. Peripheral blood stem cells (PBSC) are preferred; however, if PBSC mobilization fails, cells can be obtained by institutional practices (in cases where bone marrow will be used for transplantation, the required CD34+ dose does not apply and institutional practice for total nucleated cell dose should be used).

• Initiate conditioning therapy within 3 months of mobilization

• Signed informed consent

Exclusion Criteria:

• Karnofsky performance score less than 70%

• Transformed follicular lymphoma

• Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)

• Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent less than 5 years previously will be allowed

• Pregnant (positive β-HCG) or breastfeeding; this patient population is excluded due to the lack of data on the use of Bexxar in patients who are pregnant or breastfeeding

• Seropositivity for HIV; this patient population is excluded due to the lack of data on the use of Bexxar in HIV positive patients and because the treatment regimens are too immunosuppressive for this patient population

• Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant

• Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)

• Patients with evidence of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) or abnormal cytogenetic analysis indicative of MDS on the pre-transplant bone marrow examination

• Patients with a prior severe reaction to Rituxan or Filgrastim (G-CSF). Patients with severe reactions to G-CSF that receive pre-medication for control of the reaction are not excluded from study.

• Patients who have received prior radioimmunotherapy

• Patients with known hypersensitivity to murine proteins

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06520
2	University of Florida College of Medicine (Shands)	Gainesville	Florida	United States	32610
3	University of Miami	Miami	Florida	United States	33136
4	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33624
5	Emory University	Atlanta	Georgia	United States	30322
6	St. Lukes Mountain States Tumor Institute	Boise	Idaho	United States	83712
7	Loyola University Medical Center	Maywood	Illinois	United States	60153
8	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
9	University of Maryland Medical Systems/Greenbaum Cancer Center	Baltimore	Maryland	United States	21228
10	Johns Hopkins/SKCCC	Baltimore	Maryland	United States	21231
11	Tufts-New England Medical Center	Boston	Massachusetts	United States	02111
12	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
13	University of Minnesota	Minneapolis	Minnesota	United States	55455
14	Washington University/Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
15	University of Nebraska	Omaha	Nebraska	United States	68198
16	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
17	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
18	Weill Cornell Medical College, The New York Presbyterian Hospital	New York	New York	United States	10065
19	University of Rochester Medical Center	Rochester	New York	United States	14642
20	University of North Carolina Hospital at Chapel Hill	Chapel Hill	North Carolina	United States	27599
21	Duke University Medical Center	Durham	North Carolina	United States	27705
22	University Hospitals of Cleveland/Case Western	Cleveland	Ohio	United States	44106
23	Providence Portland Medical Center	Portland	Oregon	United States	97213
24	Columbia River Oncology Program	Portland	Oregon	United States	97225
25	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
26	Medical University of South Carolina	Charleston	South Carolina	United States	29425
27	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29615
28	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
29	Baylor University Medical Center	Dallas	Texas	United States	75246
30	Texas Transplant Institute	San Antonio	Texas	United States	78229
31	University of Utah Medical School, BMT	Salt Lake City	Utah	United States	84132
32	Intermountain BMT Program	Salt Lake City	Utah	United States	84143
33	Virginia Commonwealth University/MCV Hospital	Richmond	Virginia	United States	23298
34	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
35	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
36	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53211

Sponsors and Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)
• Blood and Marrow Transplant Clinical Trials Network
• National Cancer Institute (NCI)

Investigators

• Study Director: Mary Horowitz, MD, Center for International Blood and Marrow Transplant Research

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 20, 2010

More Information

Additional Information:

• Blood and Marrow Transplant Clinical Trials Network Website

Publications

None provided.

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT00329030
• Other Study ID Numbers: BMTCTN0401; BMT CTN 0401; U01HL069294-05; 384; NCT00415012
• First Posted: May 24, 2006
• Last Update Posted: Nov 1, 2021
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by National Heart, Lung, and Blood Institute (NHLBI): Large B-Cell Lymphoma; Non-Hodgkin's Lymphoma
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Rituximab; Tositumomab I-131

Study Results

Participant Flow

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT	Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
Period Title: Overall Study
STARTED	111	113
COMPLETED	103	107
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	B-BEAM	R-BEAM	Total
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM	Total of all reporting groups
Overall Participants	111	113	224
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.1 (13.5)	56.8 (12.5)	56.0 (13.0)
Sex: Female, Male (Count of Participants)
Female	43 38.7%	39 34.5%	82 36.6%
Male	68 61.3%	74 65.5%	142 63.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 1.8%	9 8%	11 4.9%
Not Hispanic or Latino	99 89.2%	101 89.4%	200 89.3%
Unknown or Not Reported	10 9%	3 2.7%	13 5.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 1.8%	2 0.9%
Asian	2 1.8%	3 2.7%	5 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 3.6%	3 2.7%	7 3.1%
White	99 89.2%	103 91.2%	202 90.2%
More than one race	2 1.8%	0 0%	2 0.9%
Unknown or Not Reported	4 3.6%	2 1.8%	6 2.7%
Primary Disease Stage (participants) [Number]
Primary Induction Failure	21 18.9%	15 13.3%	36 16.1%
First Relapse	35 31.5%	46 40.7%	81 36.2%
Second Complete Remission	55 49.5%	52 46%	107 47.8%
Karnofsky Performance-status Score (participants) [Number]
100%	29 26.1%	26 23%	55 24.6%
90%	67 60.4%	63 55.8%	130 58%
80%	12 10.8%	19 16.8%	31 13.8%
70%	3 2.7%	5 4.4%	8 3.6%
Disease Status at Transplantation (participants) [Number]
First Partial Response	21 18.9%	15 13.3%	36 16.1%
First Relapse	35 31.5%	45 39.8%	80 35.7%
Second Complete Remission	55 49.5%	53 46.9%	108 48.2%
Number of Prior Therapies (participants) [Number]
1	2 1.8%	7 6.2%	9 4%
2	93 83.8%	83 73.5%	176 78.6%
3	16 14.4%	23 20.4%	39 17.4%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS)
Description	Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.
Time Frame	1 and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
1 year	53.2 47.9%	56.6 50.1%
2 years	48.6 43.8%	49.0 43.4%

2. Secondary Outcome

Title	Overall Survival
Description	The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation
Time Frame	1 and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
1 year	68.5 61.7%	73.7 65.2%
2 years	60.1 54.1%	66.3 58.7%

3. Secondary Outcome

Title	Incidence of Relapse/Progression
Description	The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.
Time Frame	1 and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
1 year	39.6 35.7%	40.7 36%
2 years	44.2 39.8%	47.4 41.9%

4. Secondary Outcome

Title	Complete Response (CR) and Partial Response (PR) Proportion
Time Frame	Day 100 and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
Day 100	69.9 63%	71.0 62.8%
2 years	48.5 43.7%	43.9 38.8%

5. Secondary Outcome

Title	Platelet Recovery to 20,000 Cells/μL
Time Frame	100 and 180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
Day 100	83.5 75.2%	82.2 72.7%
Day 180	84.5 76.1%	83.2 73.6%

6. Secondary Outcome

Title	Hematologic Function
Description	Hematologic function will be defined as ANC > 1,500 neutrophils/μL, hemoglobin > 10 g/dL without transfusion support, and platelet count > 100,000/μL without transfusion support.
Time Frame	100 days, 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
Day 100	34.8 31.4%	38.5 34.1%
1 year	64.0 57.7%	58.9 52.1%

7. Secondary Outcome

Title	Incidence of Infection
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections.

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
1 Infection	38 34.2%	35 31%
2 Infections	14 12.6%	11 9.7%
3 Infections	5 4.5%	7 6.2%
4 Infections	3 2.7%	4 3.5%
5 Infections	1 0.9%	0 0%
6-10 Infections	6 5.4%	2 1.8%
>10 Infections	0 0%	1 0.9%

8. Secondary Outcome

Title	Mucositis Severity
Description	Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.
Time Frame	Day 21

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
Median (Full Range) [scores on a scale]	0.72	0.31

9. Secondary Outcome

Title	Immune Reconstitution
Description	Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
CD2 (cells/uL)	1006.0 (767.6)	1024.9 (1074.7)
CD3 (cells/uL)	921.8 (694.8)	990.3 (1056.1)
CD4 (cells/uL)	342.8 (223.9)	286.1 (213.3)
CD8 (cells/uL)	558.5 (517.9)	697.7 (901.1)
CD19 (cells/uL)	143.4 (140.5)	140.8 (203.0)
CD3+/CD25+ (cells/uL)	112.2 (92.8)	118.0 (127.7)
CD45RA (cells/uL)	469.3 (404.4)	579.8 (620.5)
CD45RO (cells/uL)	476.2 (337.4)	727.8 (798.8)
CD56+/CD3- (cells/uL)	125.1 (94.6)	130.5 (135.7)

10. Secondary Outcome

Title	Immune Reconstitution of Quantitative Immunoglobulins
Description	Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
IgA (mg/dL)	68.5 (42.6)	85.0 (71.8)
IgG (mg/dL)	619.6 (289.2)	643.8 (395.3)
IgM (mg/dL)	51.0 (36.0)	79.0 (154.4)

11. Secondary Outcome

Title	Treatment-related Mortality (TRM)
Description	TRM is defined as death occurring in a patient from causes other than relapse or progression
Time Frame	1 and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
1 year	5.9 5.3%	2.9 2.6%
2 years	5.9 5.3%	3.9 3.5%

12. Secondary Outcome

Title	Neutrophil Recovery
Description	Time to neutrophil recovery will be the first of two consecutive days of > 500 neutrophils/μL following the expected nadir.
Time Frame	Day 28 and Day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	B-BEAM	R-BEAM
Arm/Group Description	Bexxar/BEAM	Rituxan/BEAM
Measure Participants	103	107
Day 28	96.1 86.6%	93.5 82.7%
Day 60	96.1 86.6%	95.3 84.3%

Adverse Events

Time Frame	Patients will be followed for at least two years post-ASCT.
Adverse Event Reporting Description	Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Arm/Group Title	B-BEAM		R-BEAM
Arm/Group Description	Bexxar/BEAM		Rituxan/BEAM
All Cause Mortality
	B-BEAM		R-BEAM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	B-BEAM		R-BEAM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/111 (9.9%)		6/113 (5.3%)
Cardiac disorders
Sinus tachycardia	1/111 (0.9%)	1	0/113 (0%)	0
Myocardial infarction	0/111 (0%)	0	2/113 (1.8%)	2
Gastrointestinal disorders
Eosinophilic oesophagitis	1/111 (0.9%)	1	0/113 (0%)	0
Gastrointestinal haemorrhage	0/111 (0%)	0	1/113 (0.9%)	1
General disorders
Death	0/111 (0%)	0	1/113 (0.9%)	1
Hepatobiliary disorders
Cholecystitis	1/111 (0.9%)	1	0/113 (0%)	0
Immune system disorders
Acute graft versus host disease in liver	1/111 (0.9%)	1	0/113 (0%)	0
Injury, poisoning and procedural complications
Engraft failure	1/111 (0.9%)	1	0/113 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome	1/111 (0.9%)	1	0/113 (0%)	0
Acute myeloid leukaemia	0/111 (0%)	0	1/113 (0.9%)	1
Nervous system disorders
Syncope	2/111 (1.8%)	2	0/113 (0%)	0
Cerebrovascular accident	1/111 (0.9%)	1	0/113 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonitis	1/111 (0.9%)	1	0/113 (0%)	0
Acute respiratory distress syndrome	0/111 (0%)	0	1/113 (0.9%)	1
Surgical and medical procedures
Orchidectomy	1/111 (0.9%)	1	0/113 (0%)	0
Other (Not Including Serious) Adverse Events
	B-BEAM		R-BEAM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/113 (0%)

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.