Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04433182|
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: Copanlisib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Copanlisib in Combination With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma: a Multicentric Phase II Trial|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||August 1, 2024|
Experimental: Single arm Copa-RB
Induction phase with Copanlisib, Rituximab and Bendamustina. Maintenance phase (for patients who reach at least SD after induction) with Copanlisib in monotherapy.
Induction phase: 6 cycles of Copa-RB every 28 days according to the following schedule
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
Other Name: ALIQOPA
- Progression-free survival (PFS) [ Time Frame: 4 years ]Progression-Free Survival (PFS) will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause. Responding patients according to Response Criteria for NHL with PET and patients who are lost to follow-up will be censored at their last assessment date.
- Overall Survival (OS) [ Time Frame: 4 years ]Time between the date of enrolment and the date of death from any cause. Patients who have not died at the time of the final analysis will be censored at the date of the last contact.
- Overall Response Rate (ORR) [ Time Frame: End of treament (EOT), 30 months ]ORR will be defined as the sum of CR + PR
- Complete Response Rate (CRR) [ Time Frame: End of induction (EOI), 18 months ]CRR will be defined as the proportion of patients achieving a CR
- Duration of response (DOR) [ Time Frame: 4 years ]DOR is measured from the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression will be censored at their last assessment date.
- Conversion rate from SD/PR to PR/CR with maintenance [ Time Frame: End of treatment (after maintenance), 30 months ]Conversion rate from SD/PR to PR/CR with maintenance
- Evaluation of adverse events according to the current version of the CTCAE criteria [ Time Frame: 4 years ]Evaluation of adverse events according to the current version of the CTCAE criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433182
|Contact: Umberto Vitoloemail@example.com|
|Principal Investigator:||Umberto Vitolo||Ematologia, Candiolo Cancer Institute. FPO-IRCCS|