Trial · NCT02626455
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SRI: Occurrence of Dose-limiting Toxicities (DLT) | At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP | Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of \>2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting \>7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3. |
| Primary | Phase 3: Progression-free Survival (PFS) by Independent Central Review | Approximately 6 years 4 months | PFS is defined as the time from randomization to progressive disease (PD) or death from any cause (if no progression is documented). |
| Secondary | SRI: Best Overall Response | Approximately 7 years 8 months | Best overall response is defined as the best response achieved during the treatment and active follow-up periods; prior to end of study or start of new anti-tumor treatment, whichever occurs first. |
| Secondary | SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE) | Approximately 4 years 10 months | A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake. |
| Secondary | Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review | Up to 6 years 4 months | ORR, as assessed by independent central review, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS). |
| Secondary | Phase 3: ORR-Investigator Assessment | Up to 6 years 4 months | ORR, as assessed by investigator, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS). |
| Secondary | Phase 3: Duration of Tumor Response (DOR)-Independent Central Review | Approximately 6 years 4 months | DOR, as assessed by independent central review, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR. |
| Secondary | Phase 3: DOR-Investigator Assessment | Approximately 6 years 4 months | DOR, as assessed by investigator, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR. |
| Secondary | Phase 3: Complete Tumor Response Rate (CRR)-Independent Central Review | Approximately 6 years 4 months | CRR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS). |
| Secondary | Phase 3: CRR-Investigator Assessment | Approximately 6 years 4 months | CRR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS). |
| Secondary | Phase 3: Disease Control Rate (DCR)-Independent Central Review | Approximately 6 years 4 months | DCR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease). |
| Secondary | Phase 3: DCR-Investigator Assessment | Approximately 6 years 4 months | DCR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease). |
| Secondary | Phase 3: Time to Tumor Progression (TTP)-Independent Central Review | Approximately 6 years 4 months | TTP, as assessed by independent central review, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD). |
| Secondary | Phase 3: TTP-Investigator Assessment | Approximately 6 years 4 months | TTP, as assessed by investigator, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD). |
| Secondary | Phase 3: Time to Next Anti-lymphoma Treatment (TTNT) | Approximately 6 years 4 months | A new anti-lymphoma therapy is any new systemic anticancer treatment or radiotherapy for lymphoma, with a consolidation intent. TTNT was defined as the time from the date of randomization to the start of new anti-lymphoma therapy, where the date of randomization was considered Day 1. |
| Secondary | Phase 3: Overall Survival (OS) | Approximately 6 years 4 months | Overall survival is defined as the time from randomization until death from any cause. The OS for patients alive at the time of the database cut-off date was censored to the last date they were known to be alive. Deaths that occurred after the database cut-off date, reported during data cleaning, were considered for establishing the last known alive date at data cut-off. |
| Secondary | Phase 3: Time to Deterioration in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma | Approximately 6 years 4 months | Time to deterioration in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated in all patients. It is defined as the time from randomization to DRS-P decline, progression, or death from any reason, whichever occurred earlier. |
| Secondary | Phase 3: Time to Improvement in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma | Approximately 6 years 4 months | Time to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated for all patients. It is defined as the time from randomization to DRS-P improvement of at least 3 points. |
| Secondary | Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE) | Approximately 4 years | A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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