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Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma

NCT04433182 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-08-08

No results posted yet for this study

Summary

This is a multicentric single arm phase II trial, to investigate the efficacy (in terms of PFS) of the combination regimen rituximab-bendamustine in association with copanlisib in patients affected by relapsed/refractory DLBCL, not eligible to HDC and ASCT or relapsed after intensified regimens.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Copanlisib

Induction phase: 6 cycles of Copa-RB every 28 days according to the following schedule * Copanlisib (Copa): 60 mg/day i.v. on days 1,8,15 * Rituximab (R): 375 mg/sqm i.v. day 1\* * Bendamustine (B): 90 mg/sqm i.v. days 1-2\* note: during cycle 1 rituximab can be administered on day 2: in this case bendamustine will be administered on days 2-3; in the case of a frail patient or a patient with high tumor burden copanlisib could be administered on day 1, rituximab on day 2 and bendamustine on days 3-4, at physician discretion. Maintenance phase: patients who reach at least SD after induction will receive a maintenance with copanlisib in monotherapy according to the following schedule: • Copanlisib: 60 mg/day i.v. on days 1 and 15 in 28-day cycles for 1 year

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Umberto Vitolo · Ematologia, Candiolo Cancer Institute. FPO-IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2024-12-19
Completion
2024-12-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433182 on ClinicalTrials.gov