Trial Outcomes & Findings for Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation (NCT NCT00948753)
NCT ID: NCT00948753
Last Updated: 2022-05-17
Results Overview
number of Adverse Events following exposure to Maraviroc
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
1 year
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
Phase 1: 150mg Maraviroc
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Phase 1
STARTED
|
7
|
6
|
0
|
|
Phase 1
COMPLETED
|
7
|
6
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
25
|
|
Phase 2
COMPLETED
|
0
|
0
|
25
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
Baseline characteristics by cohort
| Measure |
Phase 1: 150mg Maraviroc
n=7 Participants
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Total
n=38 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
25 participants
n=5 Participants
|
38 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: patients receiving SCT
number of Adverse Events following exposure to Maraviroc
Outcome measures
| Measure |
Phase 1: 150mg Maraviroc
n=7 Participants
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Safety of Maraviroc
|
8 Number of AEs
|
6 Number of AEs
|
18 Number of AEs
|
PRIMARY outcome
Timeframe: 8 weeksEfficacy is measured by number of participants progressing to acute GVHD. If acute GVHD is noted in a participant following exposure to study drug, then efficacy was not achieved. If no GVHD was noted following exposure, then efficacy was achieved in that participant
Outcome measures
| Measure |
Phase 1: 150mg Maraviroc
n=7 Participants
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Efficacy of Maraviroc
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: pre-dose, 1,2,3,4,6,12 hours post-dosePopulation: not enough data was collected to reach statistical power for plasma maraviroc levels in the Phase 2 group.
Plasma maraviroc levels were measured in the blood with a target level of 100 ng per milliliter. Blood was drawn on Day 0 and Day 10-12 at pre-dose, 1, 2, 3, 4, 6, and 12 hours post-dose. Data was analyzed looking at the number of patients to achieve the target of 100 ng per milliliter at any time point.
Outcome measures
| Measure |
Phase 1: 150mg Maraviroc
n=7 Participants
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT
|
4 number of patients to reach target
|
6 number of patients to reach target
|
0 number of patients to reach target
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants
count of how many patients treated with Maraviroc during SCT go on to develop chronic GVHD in 1 year
Outcome measures
| Measure |
Phase 1: 150mg Maraviroc
n=7 Participants
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants who died without relapse within 1 year of SCT
Outcome measures
| Measure |
Phase 1: 150mg Maraviroc
n=7 Participants
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Rate of Early Mortality After Transplant
|
2 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year and 11 monthsNumber of participants who received Maraviroc during SCT who relapsed within 1 year and 11 months. This was based on a diagnosis made by their physician that their primary cancer had returned.
Outcome measures
| Measure |
Phase 1: 150mg Maraviroc
n=7 Participants
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 Participants
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Number of Participants Who Relapsed During Study Period
|
2 Participants
|
2 Participants
|
15 Participants
|
Adverse Events
Phase 1: 150mg Maraviroc
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1: 300mg Maraviroc
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2: 300mg Maraviroc
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: 150mg Maraviroc
n=7 participants at risk
150mg twice daily
Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 1: 300mg Maraviroc
n=6 participants at risk
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
Phase 2: 300mg Maraviroc
n=25 participants at risk
300mg twice daily
Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Mucositis
|
28.6%
2/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
20.0%
5/25 • Number of events 5
|
|
Blood and lymphatic system disorders
Bacteremia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Abnormal LFTs
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Gout
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/7
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/25
|
|
Infections and infestations
Septic arthritis
|
0.00%
0/7
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyponatremia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/25
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/25
|
|
Nervous system disorders
Headache
|
0.00%
0/7
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Acute kidney injury
|
0.00%
0/7
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7
|
0.00%
0/6
|
4.0%
1/25 • Number of events 1
|
Additional Information
David Porter
University of Pennsylvania Abramson Cancer Center
Phone: 215-662-2862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place