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A Randomized, Placebo-Controlled Multi-Site Phase 2 Study Evaluation the Safety and Efficacy of Preemptive Treatment With CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation in Adults and Children

Phase 2
3 Months
75 Years
Open (Enrolling)
Adenovirus Disease

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Trial Information

A Randomized, Placebo-Controlled Multi-Site Phase 2 Study Evaluation the Safety and Efficacy of Preemptive Treatment With CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation in Adults and Children

Inclusion Criteria:

1. Males and females ≥ 3 months and ≤ 75 years of age.

2. Subjects have received an allogeneic HSCT.

3. Positive serum AdV PCR (> 100 copies/mL) as measured by the central laboratory.

4. Subject or guardian(s) are willing to comply with the protocol.

5. Subject or guardian(s) are willing and able to understand the informed

6. Females of child-bearing potential must have a negative pregnancy test (serum
beta-hCG) and sexually active females must use a reliable and medically approved
method of contraception throughout the study. Sexually active males of procreation
potential must be able and willing to use a reliable and medically approved
contraceptive method throughout the study. At least one barrier method of
contraception must be used, in subjects of procreation potential.

Exclusion Criteria:

1. Subject has possible, probable, or definitive AdV disease. See Appendix 2Error!
Reference source not found. for a definition and criteria outlining possible,
probable or definitive AdV disease.

2. Suspected gut graft versus host disease (GVHD) that is not biopsy-proven (subjects
with a biopsy performed may be included in the study).

3. Subject has an eGFR ≤ 30 mL/minute and is not currently on dialysis.

4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 times the
ULN, conjugated bilirubin > 5 times the upper limit of normal (ULN).

5. Subject has mucositis preventing ingestion of oral medication.

6. Subject is Human Immunodeficiency Virus (HIV) antibody positive, based upon available
medical records.

7. Subject has ocular hypotony, uveitis, or retinitis or any other intraocular pathology
that would predispose the subject to one of these conditions.

8. Subject has participated in any other investigational drug study or was exposed to an
investigational drug within 14 days of enrollment.

9. Is pregnant or breast-feeding or intending to conceive during the course of the
study, including the follow-up period after drug discontinuation.

10. Known immunologic hypersensitivity to CDV or CMX001 drug or any of its excipients.

11. History of illicit drug use or alcohol abuse within the previous 6 months.

12. Any medical condition that, in the opinion of the Investigator, might interfere with
the subject's participation in the study, poses an added risk for the subject, or
confounds the assessment of the subject (e.g. severe cardiovascular, central nervous
system (CNS) or pulmonary disease).

13. Subject has received CMX001, CDV, ribavirin, or leflunomide within the previous 14

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT with asymptomatic AdV viremia

Outcome Description:

The outcome measure for the primary endpoint will be "treatment failure". Treatment failure is a composite endpoint consisting of: Progression to probable or definitive AdV disease. OR increasing AdV viremia during randomized therapy (defined as increase from baseline in AdV viremia by ≥ 1 log10, confirmed on a second measurement, at least one week apart) AND requiring discontinuation from randomized therapy

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

Related Keywords:

  • Adenovirus Disease
  • Adv
  • Hematopoeitic Stem cell Transplant
  • HSCT
  • Adenoviridae Infections



MD Anderson Cancer Center Houston, Texas  77030-4096
New York Medical College Valhalla, New York  10595
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's National Medical Center Washington, District of Columbia  20010-2970
City of Hope National Medical Center Los Angeles, California  91010
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Seattle Cancer Care Alliance Seattle, Washington  98109
Methodist Hospital Houston, Texas  77030
University of California, San Francisco San Francisco, California  94143
Children's Hospital of Alabama Birmingham, Alabama  35233
Duke University Medical Center Durham, North Carolina  27710
Cleveland Clinic Cleveland, Ohio  44195
Indiana University Indianapolis, Indiana  46202
The Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Memorial Sloan Kettering New York, New York  10021
UT Southwestern Dallas, Texas  75390
Cincinnati Childrens Hospital Cincinnati, Ohio  45229
Pheonix Children's Hospital Pheonix, Arizona  85016
Childrens hospital of LA Los Angeles, California  90033
CHOC Children's Hospital Orange, California  92868
Lucile Packard Childrens hopsital at Stanford Stanford, California  94304
The Children's Hospital-Denver Aurora, Colorado  80045
LSU Health Sciences Center New Orleans Childrens Hospital New Orleans, Louisiana  70118
Harvard-Children's Hospital Boston Boston, Massachusetts  02115
Univeristy of Minnesota Minneapolis, Minnesota  55455
St. Louis Children's Hosptial St. Louis, Missouri  63110
St. Judes Children's Research Hospital Memphis, Tennessee  38105
Baylor College of Medicine, Texas Childrens Hospital Houston, Texas  77030
Primary Children's Medical of Utah Salt Lake City, Utah  84113