Trial Outcomes & Findings for Non-Myeloablative Allogeneic Stem Cell Transplantation (NCT NCT00525876)
NCT ID: NCT00525876
Last Updated: 2011-12-07
Results Overview
Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
100 days post transplant
Results posted on
2011-12-07
Participant Flow
Recruitment Period:1/27/2005 through 8/31/2010. All participant recruitment attempted at UT MD Anderson Cancer Center.
Out of the 49 participants enrolled, 13 were excluded, not assigned to part of the two intervention study groups.
Participant milestones
| Measure |
Matched Sibling Transplant
Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
|
Allo MUD & MM
Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
|
Overall Study
COMPLETED
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Myeloablative Allogeneic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Matched Sibling Transplant
n=16 Participants
Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
|
Allo MUD & MM
n=20 Participants
Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59 years
STANDARD_DEVIATION 7 • n=5 Participants
|
59 years
STANDARD_DEVIATION 6 • n=7 Participants
|
59 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days post transplantPopulation: Analysis was per protocol.
Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.
Outcome measures
| Measure |
Matched Sibling Transplant
n=16 Participants
Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
|
Allo MUD & MM
n=20 Participants
Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
|
|---|---|---|
|
Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)
|
16 participants
|
19 participants
|
Adverse Events
Matched Sibling Transplant
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Allo MUD & MM
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Matched Sibling Transplant
n=16 participants at risk
Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
|
Allo MUD & MM
n=20 participants at risk
Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergic Reaction
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
Infections and infestations
Encephalitis
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
Infections and infestations
Aspergillus Infection
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
General disorders
Prolonged Hospitalization due to Graft vs Host Disease
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
Infections and infestations
CMV Pneumonia
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/16 • 3 years and 3 months
|
5.0%
1/20 • Number of events 1 • 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/16 • 3 years and 3 months
|
5.0%
1/20 • Number of events 1 • 3 years and 3 months
|
Other adverse events
| Measure |
Matched Sibling Transplant
n=16 participants at risk
Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
|
Allo MUD & MM
n=20 participants at risk
Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
|
|---|---|---|
|
General disorders
Epistaxis
|
0.00%
0/16 • 3 years and 3 months
|
5.0%
1/20 • Number of events 1 • 3 years and 3 months
|
|
Cardiac disorders
Lower Extremity Edema
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
15.0%
3/20 • Number of events 3 • 3 years and 3 months
|
|
Cardiac disorders
Decreased Left Ventricular Ejection Fraction
|
0.00%
0/16 • 3 years and 3 months
|
5.0%
1/20 • Number of events 1 • 3 years and 3 months
|
|
Cardiac disorders
Hypertension
|
31.2%
5/16 • Number of events 5 • 3 years and 3 months
|
30.0%
6/20 • Number of events 6 • 3 years and 3 months
|
|
Cardiac disorders
Hypotension
|
25.0%
4/16 • Number of events 4 • 3 years and 3 months
|
10.0%
2/20 • Number of events 2 • 3 years and 3 months
|
|
Cardiac disorders
Atrial Fibrillation
|
12.5%
2/16 • Number of events 2 • 3 years and 3 months
|
5.0%
1/20 • Number of events 1 • 3 years and 3 months
|
|
Cardiac disorders
Chest Pain
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
5.0%
1/20 • Number of events 1 • 3 years and 3 months
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
General disorders
Fatigue
|
43.8%
7/16 • Number of events 7 • 3 years and 3 months
|
40.0%
8/20 • Number of events 8 • 3 years and 3 months
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
10.0%
2/20 • Number of events 2 • 3 years and 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
43.8%
7/16 • Number of events 7 • 3 years and 3 months
|
15.0%
3/20 • Number of events 3 • 3 years and 3 months
|
|
Gastrointestinal disorders
Mucositis
|
18.8%
3/16 • Number of events 3 • 3 years and 3 months
|
25.0%
5/20 • Number of events 5 • 3 years and 3 months
|
|
Gastrointestinal disorders
Lower GI Bleed
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
Gastrointestinal disorders
Nausea
|
75.0%
12/16 • Number of events 12 • 3 years and 3 months
|
75.0%
15/20 • Number of events 15 • 3 years and 3 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 4 • 3 years and 3 months
|
15.0%
3/20 • Number of events 3 • 3 years and 3 months
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 3 • 3 years and 3 months
|
20.0%
4/20 • Number of events 4 • 3 years and 3 months
|
|
Renal and urinary disorders
Elevated Creatinine
|
18.8%
3/16 • Number of events 3 • 3 years and 3 months
|
35.0%
7/20 • Number of events 7 • 3 years and 3 months
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
18.8%
3/16 • Number of events 3 • 3 years and 3 months
|
25.0%
5/20 • Number of events 5 • 3 years and 3 months
|
|
Renal and urinary disorders
Dysuria
|
12.5%
2/16 • Number of events 2 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
Hepatobiliary disorders
Elevated Alkaline Phosphatase
|
31.2%
5/16 • Number of events 5 • 3 years and 3 months
|
50.0%
10/20 • Number of events 10 • 3 years and 3 months
|
|
Hepatobiliary disorders
Elevated Alanine Aminotransferase
|
37.5%
6/16 • Number of events 6 • 3 years and 3 months
|
30.0%
6/20 • Number of events 6 • 3 years and 3 months
|
|
Hepatobiliary disorders
Elevated Bilirubin
|
18.8%
3/16 • Number of events 3 • 3 years and 3 months
|
5.0%
1/20 • Number of events 1 • 3 years and 3 months
|
|
Nervous system disorders
Confusion
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
10.0%
2/20 • Number of events 2 • 3 years and 3 months
|
|
General disorders
Headache
|
37.5%
6/16 • Number of events 6 • 3 years and 3 months
|
20.0%
4/20 • Number of events 4 • 3 years and 3 months
|
|
Ear and labyrinth disorders
Hearing Loss
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
Nervous system disorders
Neuropathy
|
18.8%
3/16 • Number of events 3 • 3 years and 3 months
|
15.0%
3/20 • Number of events 3 • 3 years and 3 months
|
|
General disorders
CNS Hemorrhage
|
6.2%
1/16 • Number of events 1 • 3 years and 3 months
|
0.00%
0/20 • 3 years and 3 months
|
|
General disorders
Bone Pain
|
25.0%
4/16 • Number of events 4 • 3 years and 3 months
|
15.0%
3/20 • Number of events 3 • 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
12.5%
2/16 • Number of events 2 • 3 years and 3 months
|
25.0%
5/20 • Number of events 5 • 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
6/16 • Number of events 6 • 3 years and 3 months
|
65.0%
13/20 • Number of events 13 • 3 years and 3 months
|
|
General disorders
Graft versus Host Disease
|
37.5%
6/16 • Number of events 6 • 3 years and 3 months
|
15.0%
3/20 • Number of events 3 • 3 years and 3 months
|
|
Infections and infestations
Infections
|
100.0%
11/11 • Number of events 11 • 3 years and 3 months
|
80.0%
16/20 • Number of events 16 • 3 years and 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place