CompletedPhase 2

Efficacy and Safety Study of CSJ148 in Stem Cell Transplant Patients

United States86 participantsStarted 2015-06-02

Plain-language summary

This study is designed to test if CSJ148 can prevent HCMV replication after stem cell transplantation.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Written informed consent must be obtained before any assessment was performed.
✓. Male and female patients at least 18 years of age.
✓. Patients weighed between 45 -120 kg to participate in the study, and had a body mass index (BMI) within the range of 18 - 34 kg/m2
✓. Scheduled to undergo allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation (transplant may be related or unrelated, T-cell depleted or non-T-cell depleted, myeloablative or non-myeloablative/reduced intensity, haploidentical) and began conditioning chemotherapy within 48 hours of planned dosing day.
✓. Patient seropositive for HCMV before transplantation; donor could be seropositive or seronegative for HCMV (donor positive/recipient or donor negative/recipient positive). Historical patient HCMV serology data collected within the last 12 months or local assays could be used to qualify the patient for enrollment.
✓. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

✕. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD (pharmacodynamic) effect has returned to baseline, whichever is longer; or longer if required by local regulations.
✕. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
✕. Karnofsky performance score \<50%.
✕. Had HCMV-related organ disease within 6 months prior to enrollment.
✕. Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase chain reaction (PCR) assays prior to enrollment from samples collected within 14 days prior to enrollment. Local assays could be used to qualify the patient for enrollment.
✕. Received any of the following within 30 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (\>25 mg/kg/day IV), valacyclovir (\>3 gm/day oral), famciclovir (\>1500 mg/day oral), HCMV immune globulin, immune globulin (\>500 mg/kg), or any other medication with anti-HCMV activity.
✕. Required mechanical ventilation within 7 days prior to enrollment.
✕. Received any vasopressors or other agents for hemodynamic support within 7 days prior to enrollment. These agents included but are not limited to epinephrine, metaraminol, norepinephrine, dopamine, vasopressin, phenylephrine, and dobutamine.

Number of Participants Who Require Preemptive HCMV Therapy

Timeframe: 98 days

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Timeframe: 98 days

NCT IDNCT02268526

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-07

Results submitted2017-12-06

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Written informed consent must be obtained before any assessment was performed.
✓. Male and female patients at least 18 years of age.
✓. Patients weighed between 45 -120 kg to participate in the study, and had a body mass index (BMI) within the range of 18 - 34 kg/m2
✓. Scheduled to undergo allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation (transplant may be related or unrelated, T-cell depleted or non-T-cell depleted, myeloablative or non-myeloablative/reduced intensity, haploidentical) and began conditioning chemotherapy within 48 hours of planned dosing day.
✓. Patient seropositive for HCMV before transplantation; donor could be seropositive or seronegative for HCMV (donor positive/recipient or donor negative/recipient positive). Historical patient HCMV serology data collected within the last 12 months or local assays could be used to qualify the patient for enrollment.
✓. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

✕. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD (pharmacodynamic) effect has returned to baseline, whichever is longer; or longer if required by local regulations.
✕. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
✕. Karnofsky performance score \<50%.
✕. Had HCMV-related organ disease within 6 months prior to enrollment.
✕. Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase chain reaction (PCR) assays prior to enrollment from samples collected within 14 days prior to enrollment. Local assays could be used to qualify the patient for enrollment.
✕. Received any of the following within 30 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (\>25 mg/kg/day IV), valacyclovir (\>3 gm/day oral), famciclovir (\>1500 mg/day oral), HCMV immune globulin, immune globulin (\>500 mg/kg), or any other medication with anti-HCMV activity.
✕. Required mechanical ventilation within 7 days prior to enrollment.
✕. Received any vasopressors or other agents for hemodynamic support within 7 days prior to enrollment. These agents included but are not limited to epinephrine, metaraminol, norepinephrine, dopamine, vasopressin, phenylephrine, and dobutamine.