Trial Outcomes & Findings for Phase II Maraviroc for GVHD Prevention (NCT NCT01785810)
NCT ID: NCT01785810
Last Updated: 2021-01-11
Results Overview
The cumulative incidence of grade II-IV acute GVHD by day 180 after the stem-cell infusion. This is based on consensus conference criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
180 days
Results posted on
2021-01-11
Participant Flow
Participant milestones
| Measure |
Maraviroc
Maraviroc - 300 mg
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Maraviroc for GVHD Prevention
Baseline characteristics by cohort
| Measure |
Maraviroc
n=37 Participants
Maraviroc 300 mg
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Comorbidity Index
Low
|
7 Participants
n=5 Participants
|
|
Comorbidity Index
Intermediate
|
12 Participants
n=5 Participants
|
|
Comorbidity Index
High
|
18 Participants
n=5 Participants
|
|
Diagnosis
Acute myeloid leukemia
|
27 Participants
n=5 Participants
|
|
Diagnosis
Myelodysplastic syndrome
|
6 Participants
n=5 Participants
|
|
Diagnosis
Non-Hodgkin's lymphoma
|
1 Participants
n=5 Participants
|
|
Diagnosis
Myeloproliferative neoplasms
|
1 Participants
n=5 Participants
|
|
Diagnosis
Acute lymphoblastic leukemia
|
2 Participants
n=5 Participants
|
|
Donor
Matched unrelated
|
31 Participants
n=5 Participants
|
|
Donor
Single-antigen mismatched
|
6 Participants
n=5 Participants
|
|
Donor Age
|
32 years
n=5 Participants
|
|
Cytomegalovirus Serostatus
Recipient positive
|
18 Participants
n=5 Participants
|
|
Cytomegalovirus Serostatus
Donor positive
|
9 Participants
n=5 Participants
|
|
Cytomegalovirus Serostatus
Negative
|
10 Participants
n=5 Participants
|
|
CD34+ cell dose
|
6.2 x 10^6 cells/kg
n=5 Participants
|
|
Disease Risk Index
Low
|
3 Participants
n=5 Participants
|
|
Disease Risk Index
Intermediate
|
16 Participants
n=5 Participants
|
|
Disease Risk Index
High/very high
|
18 Participants
n=5 Participants
|
|
Donor Sex
Male
|
24 Participants
n=5 Participants
|
|
Donor Sex
Female
|
13 Participants
n=5 Participants
|
|
CD3+ cell dose
|
2.2 x 10^8 cells/kg
n=5 Participants
|
|
CD4+ cell dose
|
1.5 x 10^8 T cells/kg
n=5 Participants
|
|
CD8+ cell dose
|
0.7 x 10^8 T cells/kg
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 daysThe cumulative incidence of grade II-IV acute GVHD by day 180 after the stem-cell infusion. This is based on consensus conference criteria.
Outcome measures
| Measure |
Maraviroc
n=37 Participants
Maraviroc - 300 mg
|
|---|---|
|
Day +180 Rate of Grade II-IV Acute GVHD
|
22 Participants
|
Adverse Events
Maraviroc
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maraviroc
n=37 participants at risk
Maraviroc - dose level of 300 mg
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
1/37 • Number of events 1 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
1/37 • Number of events 1 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Cardiac disorders
Pericardial effusion
|
2.7%
1/37 • Number of events 1 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.7%
1/37 • Number of events 1 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.4%
2/37 • Number of events 2 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Infections and infestations
Sepsis
|
5.4%
2/37 • Number of events 2 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
Other adverse events
| Measure |
Maraviroc
n=37 participants at risk
Maraviroc - dose level of 300 mg
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.9%
7/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.5%
5/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Cardiac disorders
Pericardial effusion
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Diarrhea
|
10.8%
4/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Esophagitis
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Oral pain
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Rectal mucositis
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
White blood cell decreased
|
18.9%
7/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Aspartate aminotransferase increased
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Prolonged partial thromboplastin time
|
10.8%
4/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.8%
4/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Nausea
|
10.8%
4/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.8%
4/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
General disorders
Fatigue
|
10.8%
4/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Lymphocyte count decreased
|
18.9%
7/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Hypercalcemia
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
INR Increased
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Hyperbilirubinemia
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
General disorders
Edema limbs
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Vascular disorders
Hypotension
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Oral mucositis
|
13.5%
5/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.2%
6/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Alkaline phosphatase increased
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Decreased platelets
|
18.9%
7/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Rectal pain
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Creatinine Elevated
|
10.8%
4/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Renal and urinary disorders
Hematuria
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
3/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Investigations
Neutropenia
|
18.9%
7/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
General disorders
Multi-organ failure
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Psychiatric disorders
Anxiety
|
5.4%
2/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
General disorders
Fever
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Renal and urinary disorders
Bladder spasm
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Vascular disorders
Flushing
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Bloating
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Renal and urinary disorders
Urinary retention
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
2.7%
1/37 • From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place