Trial Outcomes & Findings for Atorvastatin for the Prophylaxis of Acute GVHD in Patients Undergoing Matched Sibling Allogeneic Transplantation (NCT NCT01175148)
NCT ID: NCT01175148
Last Updated: 2017-06-07
Results Overview
Cummalative incidence of grade 2 to 4 acute Graft vs Host Diesease (GVHD) at day 100 post transplant will be will be histologically confirmed and graded in Hematopoietic Stem Cell Transplantation Recipients
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
100 days post transplant
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Recipient Arm
Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily
|
Donor Arm
Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atorvastatin for the Prophylaxis of Acute GVHD in Patients Undergoing Matched Sibling Allogeneic Transplantation
Baseline characteristics by cohort
| Measure |
Recipient Arm
n=30 Participants
Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily
|
Donor Arm
n=30 Participants
Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-49
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Age, Customized
50--69
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Age, Customized
70-80
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days post transplantPopulation: Only the Recipients were analyzed for the outcome measurements.
Cummalative incidence of grade 2 to 4 acute Graft vs Host Diesease (GVHD) at day 100 post transplant will be will be histologically confirmed and graded in Hematopoietic Stem Cell Transplantation Recipients
Outcome measures
| Measure |
Recipient Arm - Experimental
n=30 Participants
Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily
|
|---|---|
|
Cummalative Incidence of Grade 2 to 4 Acute Graft vs Host Diesease (GVHD) at Day 100 Post Transplant in HSCT Recipients
|
3.3 percentage of participants
Interval 0.2 to 14.8
|
Adverse Events
Recipient Arm - Experimental
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Donor Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recipient Arm - Experimental
n=30 participants at risk
Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily
|
Donor Arm
n=30 participants at risk
Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
10.0%
3/30 • 2 years from study enrollment
|
0.00%
0/30 • 2 years from study enrollment
|
|
Blood and lymphatic system disorders
Ankle Edema
|
3.3%
1/30 • 2 years from study enrollment
|
0.00%
0/30 • 2 years from study enrollment
|
|
Nervous system disorders
Fatigue
|
3.3%
1/30 • 2 years from study enrollment
|
0.00%
0/30 • 2 years from study enrollment
|
|
Hepatobiliary disorders
Liver Function Tests
|
6.7%
2/30 • 2 years from study enrollment
|
0.00%
0/30 • 2 years from study enrollment
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • 2 years from study enrollment
|
0.00%
0/30 • 2 years from study enrollment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • 2 years from study enrollment
|
3.3%
1/30 • 2 years from study enrollment
|
Additional Information
Pam Bunner, Clinical Research Specialist
Mary Babb Randolph Cancer Center
Phone: 304-598-4511
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place