Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Grade 3b Follicular Lymphoma
  • Non Hodgkin's Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

OUTLINE: This is a dose-escalation study of copanlisib. Patients receive copanlisib intravenously (IV) and gemcitabine IV on days 1 and 8, carboplatin IV and rituximab IV on day 1, and dexamethasone orally (PO) or IV 30-60 minutes prior to chemotherapy on day 1 or PO in the morning (AM) and 30-60 mi...

OUTLINE: This is a dose-escalation study of copanlisib. Patients receive copanlisib intravenously (IV) and gemcitabine IV on days 1 and 8, carboplatin IV and rituximab IV on day 1, and dexamethasone orally (PO) or IV 30-60 minutes prior to chemotherapy on day 1 or PO in the morning (AM) and 30-60 minutes prior to chemotherapy on days 2-4. Patients also receive pegfilgrastim subcutaneously (SC) on day 8 or 9. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for up to 1 year.

Tracking Information

NCT #
NCT04156828
Collaborators
  • National Cancer Institute (NCI)
  • Bayer
Investigators
Principal Investigator: Ryan Lynch Fred Hutch/University of Washington Cancer Consortium