Trial Outcomes & Findings for Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies (NCT NCT00472056)
NCT ID: NCT00472056
Last Updated: 2016-03-15
Results Overview
DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Up to 5 years from transplant date.
Results posted on
2016-03-15
Participant Flow
Recruitment Period: March 03, 2005 to June 19, 2009. All recruitment done at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
Cohort 1 65 Years of Age or Less With Arm 2
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 1 65 Years of Age or Less With Arm 1
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
19
|
32
|
17
|
|
Overall Study
COMPLETED
|
25
|
19
|
32
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
Cohort 1 65 Years of Age or Less With Arm 2
n=25 Participants
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1
n=19 Participants
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 1 65 Years of Age or Less With Arm 1
n=32 Participants
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2
n=17 Participants
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 7.58288 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 3.50522 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 11.93155 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 3.43211 • n=4 Participants
|
61 years
STANDARD_DEVIATION 11.17466 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
19 participants
n=7 Participants
|
32 participants
n=5 Participants
|
17 participants
n=4 Participants
|
93 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years from transplant date.Population: Analysis was per protocol.
DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.
Outcome measures
| Measure |
Standard Dose Rituximab
n=51 Participants
Standard dose arm: Rituximab 375 mg/m\^2 intravenous on days +1 and +8 after stem cell infusion.
|
High Dose Rituximab
n=42 Participants
High dose arm: Rituximab 1000mg/m\^2 intravenous on days +1 and +8 after stem cell infusion
|
|---|---|---|
|
Disease-free Survival (DFS)
|
11.33 months
Interval 1.81 to 39.29
|
9.635 months
Interval 1.77 to 31.45
|
Adverse Events
Cohort 1 65 Years of Age or Less With Arm 2
Serious events: 14 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 1 65 Years of Age or Less With Arm 1
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 65 Years of Age or Less With Arm 2
n=25 participants at risk
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1
n=19 participants at risk
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 1 65 Years of Age or Less With Arm 1
n=32 participants at risk
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2
n=17 participants at risk
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Mucositis
|
4.0%
1/25 • Number of events 1 • 4 Years, 5 Months
|
0.00%
0/19 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
0.00%
0/17 • 4 Years, 5 Months
|
|
Infections and infestations
Neutropenic fever
|
36.0%
9/25 • Number of events 9 • 4 Years, 5 Months
|
31.6%
6/19 • Number of events 7 • 4 Years, 5 Months
|
25.0%
8/32 • Number of events 8 • 4 Years, 5 Months
|
23.5%
4/17 • Number of events 4 • 4 Years, 5 Months
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 1 • 4 Years, 5 Months
|
15.8%
3/19 • Number of events 3 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
5.9%
1/17 • Number of events 1 • 4 Years, 5 Months
|
|
Renal and urinary disorders
Renal Insufficiency
|
4.0%
1/25 • Number of events 1 • 4 Years, 5 Months
|
0.00%
0/19 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
0.00%
0/17 • 4 Years, 5 Months
|
|
Infections and infestations
Infection
|
16.0%
4/25 • Number of events 6 • 4 Years, 5 Months
|
10.5%
2/19 • Number of events 2 • 4 Years, 5 Months
|
9.4%
3/32 • Number of events 6 • 4 Years, 5 Months
|
17.6%
3/17 • Number of events 5 • 4 Years, 5 Months
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/25 • 4 Years, 5 Months
|
5.3%
1/19 • Number of events 1 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
0.00%
0/17 • 4 Years, 5 Months
|
|
Hepatobiliary disorders
Transaminitis
|
0.00%
0/25 • 4 Years, 5 Months
|
10.5%
2/19 • Number of events 2 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
0.00%
0/17 • 4 Years, 5 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
4.0%
1/25 • Number of events 1 • 4 Years, 5 Months
|
0.00%
0/19 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
0.00%
0/17 • 4 Years, 5 Months
|
|
Blood and lymphatic system disorders
Low Platelets
|
8.0%
2/25 • Number of events 2 • 4 Years, 5 Months
|
0.00%
0/19 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
0.00%
0/17 • 4 Years, 5 Months
|
|
Musculoskeletal and connective tissue disorders
Failure to Thrive
|
0.00%
0/25 • 4 Years, 5 Months
|
5.3%
1/19 • Number of events 1 • 4 Years, 5 Months
|
0.00%
0/32 • 4 Years, 5 Months
|
0.00%
0/17 • 4 Years, 5 Months
|
Other adverse events
| Measure |
Cohort 1 65 Years of Age or Less With Arm 2
n=25 participants at risk
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1
n=19 participants at risk
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 1 65 Years of Age or Less With Arm 1
n=32 participants at risk
Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
|
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2
n=17 participants at risk
Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
60.0%
15/25 • Number of events 15 • 4 Years, 5 Months
|
63.2%
12/19 • Number of events 12 • 4 Years, 5 Months
|
78.1%
25/32 • Number of events 25 • 4 Years, 5 Months
|
70.6%
12/17 • Number of events 12 • 4 Years, 5 Months
|
|
Gastrointestinal disorders
Diarrhea
|
72.0%
18/25 • Number of events 18 • 4 Years, 5 Months
|
42.1%
8/19 • Number of events 8 • 4 Years, 5 Months
|
65.6%
21/32 • Number of events 21 • 4 Years, 5 Months
|
52.9%
9/17 • Number of events 9 • 4 Years, 5 Months
|
|
Gastrointestinal disorders
Mucositis
|
76.0%
19/25 • Number of events 19 • 4 Years, 5 Months
|
31.6%
6/19 • Number of events 6 • 4 Years, 5 Months
|
87.5%
28/32 • Number of events 28 • 4 Years, 5 Months
|
64.7%
11/17 • Number of events 11 • 4 Years, 5 Months
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.00%
0/25 • 4 Years, 5 Months
|
15.8%
3/19 • Number of events 3 • 4 Years, 5 Months
|
6.2%
2/32 • Number of events 2 • 4 Years, 5 Months
|
5.9%
1/17 • Number of events 1 • 4 Years, 5 Months
|
|
Hepatobiliary disorders
Transaminitis
|
4.0%
1/25 • Number of events 1 • 4 Years, 5 Months
|
10.5%
2/19 • Number of events 3 • 4 Years, 5 Months
|
15.6%
5/32 • Number of events 6 • 4 Years, 5 Months
|
5.9%
1/17 • Number of events 1 • 4 Years, 5 Months
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
4.0%
1/25 • Number of events 1 • 4 Years, 5 Months
|
21.1%
4/19 • Number of events 4 • 4 Years, 5 Months
|
18.8%
6/32 • Number of events 6 • 4 Years, 5 Months
|
41.2%
7/17 • Number of events 7 • 4 Years, 5 Months
|
|
Infections and infestations
Fever
|
8.0%
2/25 • Number of events 3 • 4 Years, 5 Months
|
0.00%
0/19 • 4 Years, 5 Months
|
3.1%
1/32 • Number of events 1 • 4 Years, 5 Months
|
5.9%
1/17 • Number of events 1 • 4 Years, 5 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
5/25 • Number of events 5 • 4 Years, 5 Months
|
5.3%
1/19 • Number of events 1 • 4 Years, 5 Months
|
3.1%
1/32 • Number of events 1 • 4 Years, 5 Months
|
5.9%
1/17 • Number of events 1 • 4 Years, 5 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place