Trial Outcomes & Findings for Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation (NCT NCT00591630)
NCT ID: NCT00591630
Last Updated: 2021-02-02
Results Overview
Response evaluated using the standard criteria response for lymphoma through CT scan.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
2 years (beginning day 30 after treatment)
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 1 - Zevalin + BEAM + Stem Cell Transplant
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Rituximab + Stem Cell Transplant
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Stem Cell Transplant
BEAM + Rituximab Followed by Stem Cell Transplant
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
10
|
6
|
|
Overall Study
COMPLETED
|
6
|
8
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 1 - Zevalin + BEAM + Stem Cell Transplant
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Rituximab + Stem Cell Transplant
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Stem Cell Transplant
BEAM + Rituximab Followed by Stem Cell Transplant
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant
n=6 Participants
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 1 - Zevalin + BEAM + Stem Cell Transplant
n=8 Participants
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Rituximab + Stem Cell Transplant
n=10 Participants
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Stem Cell Transplant
n=6 Participants
BEAM + Rituximab Followed by Stem Cell Transplant
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
6 participants
n=4 Participants
|
30 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 years (beginning day 30 after treatment)Response evaluated using the standard criteria response for lymphoma through CT scan.
Outcome measures
| Measure |
Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant
n=6 Participants
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 1 - Zevalin + BEAM + Stem Cell Transplant
n=8 Participants
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Rituximab + Stem Cell Transplant
n=10 Participants
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Stem Cell Transplant
n=6 Participants
BEAM + Rituximab Followed by Stem Cell Transplant
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
|---|---|---|---|---|
|
Number of Participants With a 2-Year Progression-Free Survival (PFS)
|
6 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
Adverse Events
Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 1 - Zevalin + BEAM + Stem Cell Transplant
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2 - BEAM + Rituximab + Stem Cell Transplant
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Group 2 - BEAM + Stem Cell Transplant
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant
n=6 participants at risk
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 1 - Zevalin + BEAM + Stem Cell Transplant
n=8 participants at risk
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Rituximab + Stem Cell Transplant
n=10 participants at risk
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Stem Cell Transplant
n=6 participants at risk
BEAM + Rituximab Followed by Stem Cell Transplant
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
|---|---|---|---|---|
|
Cardiac disorders
CD OTH
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
10.0%
1/10 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Nervous system disorders
NE OTH
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
10.0%
1/10 • 3 Years
|
0.00%
0/6 • 3 Years
|
Other adverse events
| Measure |
Group 1 - Zevalin + BEAM + Rituximab +Stem Cell Transplant
n=6 participants at risk
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 1 - Zevalin + BEAM + Stem Cell Transplant
n=8 participants at risk
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
Zevalin: (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Rituximab + Stem Cell Transplant
n=10 participants at risk
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
Group 2 - BEAM + Stem Cell Transplant
n=6 participants at risk
BEAM + Rituximab Followed by Stem Cell Transplant
Carmustine: 300 mg/m\^2 by vein.
Etoposide: 200 mg/m\^2 by vein every 12 hours.
Cytarabine: 200 mg/m\^2 by vein every 12 hours.
Melphalan: 140 mg/m\^2 by vein.
Rituximab: Arm 1, Arm 2 = 250 mg/m\^2 by vein;
Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant;
Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Stem Cell Transplant: Injection of stem cells (Autologous SCT)
|
|---|---|---|---|---|
|
Investigations
ALK increased
|
16.7%
1/6 • 3 Years
|
37.5%
3/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
66.7%
4/6 • 3 Years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Investigations
ALT increased
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Infections and infestations
Bacterial
|
33.3%
2/6 • 3 Years
|
25.0%
2/8 • 3 Years
|
22.2%
2/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Blood and lymphatic system disorders
Bleeding (no GI no PUL)
|
16.7%
1/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
General disorders
Bone pain
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Cardiac disorders
CD OTH
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Cardiac disorders
Chest pain
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • 3 Years
|
12.5%
1/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • 3 Years
|
12.5%
1/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
6/6 • 3 Years
|
87.5%
7/8 • 3 Years
|
44.4%
4/9 • 3 Years
|
33.3%
2/6 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Cardiac disorders
Dysrhythmia
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
General disorders
Edema
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
General disorders
Fatigue
|
16.7%
1/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
2/6 • 3 Years
|
75.0%
6/8 • 3 Years
|
55.6%
5/9 • 3 Years
|
83.3%
5/6 • 3 Years
|
|
General disorders
Fever
|
0.00%
0/6 • 3 Years
|
12.5%
1/8 • 3 Years
|
33.3%
3/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
General disorders
Flu like syndrome
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
General disorders
Fluid overload
|
33.3%
2/6 • 3 Years
|
25.0%
2/8 • 3 Years
|
44.4%
4/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Infections and infestations
Fungal
|
0.00%
0/6 • 3 Years
|
12.5%
1/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 3 Years
|
12.5%
1/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • 3 Years
|
37.5%
3/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • 3 Years
|
12.5%
1/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Infections and infestations
IN FEC
|
16.7%
1/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6 • 3 Years
|
100.0%
8/8 • 3 Years
|
100.0%
9/9 • 3 Years
|
83.3%
5/6 • 3 Years
|
|
Nervous system disorders
NE COR
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Nervous system disorders
NE OTH
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Gastrointestinal disorders
Oral mucositis
|
100.0%
6/6 • 3 Years
|
100.0%
8/8 • 3 Years
|
77.8%
7/9 • 3 Years
|
83.3%
5/6 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
0.00%
0/6 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • 3 Years
|
25.0%
2/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
22.2%
2/9 • 3 Years
|
33.3%
2/6 • 3 Years
|
|
Investigations
T bilirubin increased
|
16.7%
1/6 • 3 Years
|
12.5%
1/8 • 3 Years
|
11.1%
1/9 • 3 Years
|
33.3%
2/6 • 3 Years
|
|
Infections and infestations
Viral
|
16.7%
1/6 • 3 Years
|
0.00%
0/8 • 3 Years
|
0.00%
0/9 • 3 Years
|
16.7%
1/6 • 3 Years
|
Additional Information
Issa F. Khouri, MD / Stem Cell Transplantation
University of Texas MD Anderson Cancer Center
Phone: 713-792-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place