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Brief Title: Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
Official Title: A Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
Study ID: NCT04161248
Brief Summary: The purpose of this study is to find the highest dose of a new drug, in combination with standard drugs, which can be tolerated without causing very severe side effects. The study treatment is new agents in combination with R-GDP or an equivalent regimen.
Detailed Description: To find the highest dose of a new drug that can be tolerated without causing severe side effects when receiving R-GDP or an equivalent regimen. This is done by starting at a dose lower than the one that is tolerated in patients when given on its own. Participants are given the new drug together with R-GDP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then new participants will be given a higher dose of the new drug. Participants joining the study later on will get higher doses of the new drug than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
University Health Network, Toronto, Ontario, Canada
The Jewish General Hospital, Montreal, Quebec, Canada
Name: Sarit Assouline
Affiliation: The Jewish General Hospital, Montreal QC, Canada
Role: STUDY_CHAIR
Name: Diego Villa
Affiliation: BCCA - Vancouver Cancer Centre, BC, Canada
Role: STUDY_CHAIR
Name: Tara Baetz
Affiliation: Cancer Centre of Southeastern Ontario at Kingston, ON, Canada
Role: STUDY_CHAIR