Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma
Last updated on July 2021Recruitment
- 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