Copanlisib Plus Venetoclax in R/R DLBCL

Part of paid clinical trials in Duarte, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04572763
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Large B Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Relapsed Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copanlisib — DRUG
    Intravenous infusion
  • Venetoclax — DRUG
    Tablet taken orally

Study Details

This research study is evaluating the combination of two drugs, copanlisib and venetoclax, as a possible treatment for trelapsed/refractory diffuse large B-cell lymphoma (DLBCL) The names of the study drugs involved in this study are: * Copanlisib * Venetoclax

Key Dates

Start date
Sep 8, 2021
Status verified
Jan 2026
Primary completion
Jul 29, 2025
Completion
Jul 29, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Copanlisib + Venetoclax
    Phase 1 * Dose escalation will occur using a 3+3 design * Copanlisib will be administered IV on days 1, 8 and 15 in 28 day cycle * Venetoclax will be administered orally daily for each 28-day cycle. During cycle 1, a venetoclax dose ramp-up is performed in the outpatient setting
  • Experimental: Recommended phase II dose (RP2D) Copanlisib + Venetoclax
    Patients will be treated with copanlisib in combination with venetoclax, administered at the Recommended phase II dose (RP2D).

Primary Outcome Measure

Maximum tolerated dose of venetoclax in combination with copanlisib (recommended phase II dose (RP2D) - Phase 1 [ Time Frame: 28 Days up to 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110-

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center· Duarte, CADana-Farber Cancer Institute· Boston, MASiteman Cancer Center at Washington University· St Louis, MO

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