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Phase II Maraviroc for GVHD Prevention

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ClinicalTrials.gov Identifier: NCT01785810
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hematologic Malignancy
Intervention Drug: Maraviroc 300 mg
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc - 300 mg
Period Title: Overall Study
Started 37
Completed 29
Not Completed 8
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc 300 mg
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
65
(49 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
14
  37.8%
Male
23
  62.2%
Comorbidity Index   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Low
7
  18.9%
Intermediate
12
  32.4%
High
18
  48.6%
[1]
Measure Description: The comorbidity index indicates the presence of other medical conditions that increase the risk of hospitalization or death. The high category indicates a score >2.
Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Acute myeloid leukemia
27
  73.0%
Myelodysplastic syndrome
6
  16.2%
Non-Hodgkin's lymphoma
1
   2.7%
Myeloproliferative neoplasms
1
   2.7%
Acute lymphoblastic leukemia
2
   5.4%
Donor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Matched unrelated
31
  83.8%
Single-antigen mismatched
6
  16.2%
Donor Age  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
32
(19 to 53)
Cytomegalovirus Serostatus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Recipient positive
18
  48.6%
Donor positive
9
  24.3%
Negative
10
  27.0%
CD34+ cell dose  
Mean (Full Range)
Unit of measure:  X 10^6 cells/kg
Number Analyzed 37 participants
6.2
(1.5 to 20.2)
Disease Risk Index   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Low
3
   8.1%
Intermediate
16
  43.2%
High/very high
18
  48.6%
[1]
Measure Description: The disease risk index uses information about the underlying disease and disease status to categorize patients according to risk of relapse and survival.
Donor Sex  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Male
24
  64.9%
Female
13
  35.1%
CD3+ cell dose  
Mean (Full Range)
Unit of measure:  X 10^8 cells/kg
Number Analyzed 37 participants
2.2
(0.6 to 8.1)
CD4+ cell dose  
Mean (Full Range)
Unit of measure:  X 10^8 T cells/kg
Number Analyzed 37 participants
1.5
(0.3 to 5.4)
CD8+ cell dose  
Mean (Full Range)
Unit of measure:  X 10^8 T cells/kg
Number Analyzed 37 participants
0.7
(0.1 to 2.2)
1.Primary Outcome
Title Day +180 Rate of Grade II-IV Acute GVHD
Hide Description The cumulative incidence of grade II-IV acute GVHD by day 180 after the stem-cell infusion. This is based on consensus conference criteria.
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc - 300 mg
Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
22
  59.5%
Time Frame From the initiation of maraviroc (Day -3) to d+ 120 days following stem-cell infusion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc - dose level of 300 mg
All-Cause Mortality
Maraviroc
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Maraviroc
Affected / at Risk (%) # Events
Total   5/37 (13.51%)    
Blood and lymphatic system disorders   
Febrile neutropenia *  2/37 (5.41%)  2
Cardiac disorders   
Pericardial effusion *  1/37 (2.70%)  1
Infections and infestations   
Sepsis *  2/37 (5.41%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  1/37 (2.70%)  1
Hypoxia *  1/37 (2.70%)  1
Pulmonary edema *  1/37 (2.70%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maraviroc
Affected / at Risk (%) # Events
Total   29/37 (78.38%)    
Blood and lymphatic system disorders   
Anemia   7/37 (18.92%) 
Febrile Neutropenia   1/37 (2.70%) 
Cardiac disorders   
Pericardial effusion *  1/37 (2.70%) 
Gastrointestinal disorders   
Diarrhea   4/37 (10.81%) 
Esophagitis   1/37 (2.70%) 
Hemorrhoidal hemorrhage   1/37 (2.70%) 
Vomiting   3/37 (8.11%) 
Oral pain   1/37 (2.70%) 
Rectal mucositis   1/37 (2.70%) 
Nausea   4/37 (10.81%) 
Oral mucositis   5/37 (13.51%) 
Constipation   2/37 (5.41%) 
Hemorrhoids   1/37 (2.70%) 
Rectal pain   1/37 (2.70%) 
Dysphagia   1/37 (2.70%) 
Abdominal pain   1/37 (2.70%) 
Bloating   1/37 (2.70%) 
Abdominal distension   1/37 (2.70%) 
Flatulence   1/37 (2.70%) 
General disorders   
Fatigue   4/37 (10.81%) 
Edema limbs   2/37 (5.41%) 
Multi-organ failure   1/37 (2.70%) 
Fever   1/37 (2.70%) 
Investigations   
White blood cell decreased   7/37 (18.92%) 
Aspartate aminotransferase increased   3/37 (8.11%) 
Prolonged partial thromboplastin time   4/37 (10.81%) 
Lymphocyte count decreased   7/37 (18.92%) 
Alanine aminotransferase increased   3/37 (8.11%) 
Hypercalcemia   1/37 (2.70%) 
INR Increased   3/37 (8.11%) 
Hyperbilirubinemia   3/37 (8.11%) 
Alkaline phosphatase increased   1/37 (2.70%) 
Decreased platelets   7/37 (18.92%) 
Creatinine Elevated   4/37 (10.81%) 
Neutropenia   7/37 (18.92%) 
Metabolism and nutrition disorders   
Hyponatremia   5/37 (13.51%) 
Hypoglycemia   1/37 (2.70%) 
Hypomagnesemia   3/37 (8.11%) 
Hypokalemia   2/37 (5.41%) 
Hypocalcemia   4/37 (10.81%) 
Anorexia   4/37 (10.81%) 
Dehydration   3/37 (8.11%) 
Hyperkalemia   3/37 (8.11%) 
Hypophosphatemia   2/37 (5.41%) 
Hypoalbuminemia   2/37 (5.41%) 
Hyperglycemia   6/37 (16.22%) 
Tumor lysis syndrome   1/37 (2.70%) 
Hypermagnesemia   1/37 (2.70%) 
Musculoskeletal and connective tissue disorders   
Flank pain   1/37 (2.70%) 
Generalized muscle weakness   2/37 (5.41%) 
Back pain   1/37 (2.70%) 
Neck pain   1/37 (2.70%) 
Nervous system disorders   
Dysgeusia   1/37 (2.70%) 
Peripheral sensory neuropathy   1/37 (2.70%) 
Headache   1/37 (2.70%) 
Dizziness   1/37 (2.70%) 
Depressed level of consciousness   1/37 (2.70%) 
Psychiatric disorders   
Depression   1/37 (2.70%) 
Anxiety   2/37 (5.41%) 
Renal and urinary disorders   
Hematuria   1/37 (2.70%) 
Bladder spasm   1/37 (2.70%) 
Urinary retention   1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders   
Postnasal drip   1/37 (2.70%) 
Dyspnea   2/37 (5.41%) 
Sore throat   2/37 (5.41%) 
Respiratory failure   1/37 (2.70%) 
Epistaxis   1/37 (2.70%) 
Hypoxia   1/37 (2.70%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme   1/37 (2.70%) 
Urticaria   1/37 (2.70%) 
Pruritus   3/37 (8.11%) 
Rash maculopapular   1/37 (2.70%) 
Vascular disorders   
Hypotension   2/37 (5.41%) 
Flushing   1/37 (2.70%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Gardo
Organization: Abramson Cancer Center
Phone: 215-615-2232
EMail: michael.gardo@uphs.upenn.edu
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01785810    
Other Study ID Numbers: UPCC 04712
First Submitted: February 5, 2013
First Posted: February 7, 2013
Results First Submitted: September 24, 2020
Results First Posted: January 11, 2021
Last Update Posted: January 11, 2021